No longer must you wait until the National Enquirer gets a hot tip from an anonymous source that "various celebrities" are getting facials made from liquefied cells of a baby's foreskin to learn about the latest skincare trends on the market. In 2020, we suggest a slightly more discerning approach: get your forecast on the biggest treatments and ingredients to try in the new year straight from the experts.

To be clear, that doesn't mean the future of skin care is any less exciting or innovative. (As dermatologist Matthew Elias, MD, put it: "2020 is going to be a banner year for skin care.") There will be blood, personalization, and a slight tweak to the lip filler movement you've been seeing everywhere of late. TDLR? The next phase of skincare trends will be anything but boring, and we asked a handful of derms to break down which ones you should be most excited about in 2020.

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These 5 Skincare Trends Are the Wave of the Future, and You'll See 'Em Everywhere in 2020 - POPSUGAR

Skin Stem Cells Comments Off on These 5 Skincare Trends Are the Wave of the Future, and You’ll See ‘Em Everywhere in 2020 – POPSUGAR | December 18th, 2019

Specializing in innovative cosmetic applications for the face, eyes, and body, Dr. Zamora is a leader in minimally invasive treatments.

DENVER (PRWEB) December 18, 2019

Dr. Jack Zamora, a renowned face expert in Denver, Colorado has joined the esteemed Haute Beauty network.

The Haute Beauty Network, well known for its exclusive and luxurious lifestyle publication Haute Living is privileged to present Dr. Jack Zamora as a face expert and our newest addition to the Haute Beauty members-only network.

Haute Beauty offers a prominent collective of leading doctors. The invitation-only exclusive publication maintains elite as ever, with only two doctors in every market. This partnership allows Haute Beauty to connect its affluent readers with industry-leading aesthetic surgeons located in their area.

ABOUT DR. ZAMORADr. Jack Zamora is an oculofacial plastic surgeon, and a pioneer in plasma treatments and stem cell technology. Specializing in innovative cosmetic applications for the face, eyes, and body, Dr. Zamora is a leader in minimally invasive treatments. Graduating from Tulane University in New Orleans, he received a doctorate degree in medicine and completed his internship at Boston Medical Center (internal medicine), his residency at Boston University (ophthalmology department), and completed his fellowship at Boston University (ophthalmology and oculoplastics).

Dr. Zamora is the medical director of several locations throughout Colorado offering select surgical and non-surgical facial refinement, skin rejuvenation, and body sculpting services. Known for exceptional patient care and state-of-the-art procedures that achieve natural-looking results with as little downtime as possible, Dr. Zamora and his team work with each patient to tailor a combination of treatments for long-term results.

As the creator of J-Plazty, Dr. Zamora has received national and international attention for his revolutionary technique. J-Plazty is a minimally invasive procedure that uses Renuvion plasma energy sub-dermally to instantly tighten and rejuvenate skin anywhere on the face and body without large incisions, downtime, or the complications of traditional surgery. As an authority on skin tightening applications, Dr. Zamora has seen remarkable results with plasma and often combines it with other radiofrequency (RF) modalities for superior rejuvenation. Utilizing his plasma techniques with micro and macro-needling radiofrequency (RF), Dr. Zamora is seeing unparalleled skin shrinkage as well as tightening of extremely delicate tissue allowing for long-term improvement with less downtime

In an effort to improve the outcome of aesthetic procedures, Dr. Zamora has partnered with Vitro BioPharma to develop the worlds first ultra pure cosmetic stem cell serum, InfiniVive MD, to be used topically by plastic surgeons, cosmetic surgeons, and aestheticians throughout the United States. InfiniVive MD is the highest quality cGMP-grade cosmetic stem cell serum containing ultra pure mesenchymal stem cells and exosomes. InfiniVive MD is to be used with ablative and non- ablative lasers, plasma energy technologies, and microneedling radiofrequency. The serum provides an unprecedented improvement in fine lines and wrinkles, helps reduce the signs of aging, and helps promote accelerated healing.

Being an international trainer for J-Plazty, Apyx Medical, and Bausch Health Companies Inc., and a luminary for AMP Medical, Lutronic Medical, and Syneron ELOS, Dr. Zamora offers his expertise to physicians from around the globe. He is a regular speaker and consultant, has been featured on The Doctors TV Show, and has written on the techniques and parameters of soft tissue coagulation and subcutaneous neck skin plasma tightening. Valuing continued education, Dr. Zamora created the Jack Zamora MD Aesthetic Institute, which offers advanced aesthetic training to medical professionals and licensed aestheticians.

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LONDON, Dec. 18, 2019 /PRNewswire/ --GSK today announced positive headline results for intravenous (IV) Benlysta (belimumab) in the largest controlled phase 3 study in active lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE) which can lead to end-stage kidney disease.

The Efficacy and Safety of Belimumab in Patients with Active Lupus Nephritis (BLISS-LN) study, involving 448 patients, met its primary endpoint demonstrating that a statistically significant greater number of patients achieved Primary Efficacy Renal Response (PERR) over two years when treated with belimumab plus standard therapy compared to placebo plus standard therapy in adults with active LN (43% vs 32%, odds ratio (95% CI) 1.55 (1.04, 2.32), p=0.0311).

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK said: "Lupus nephritis is one of the most common and serious complications of SLE, occurring in up to 60% of adult patients. The results of the BLISS-LN study show that Benlysta could make a clinically meaningful improvement to the lives of these patients who currently have limited treatment options."

Dr Richard Furie,Chief of the Division of Rheumatology and Professor at the Feinstein Institutes atNorthwell Health and Lead Investigator of BLISS-LN said: "My journey with Benlysta began nearly twenty years ago when we performed the very first clinical research trial in lupus patients. To see it culminate in a successful phase 3 lupus nephritis study is a key achievement as the inadequate response of our patients with kidney disease to conventional treatment has long been an area in need of major improvement."

Belimumab also demonstrated statistical significance compared to placebo across all four major secondary endpoints: Complete Renal Response (CRR) after two years (the most stringent measure of renal response), Ordinal Renal Response (ORR) after two years, PERR after one year, and the time to death or renal-related event. In BLISS-LN, safety results for patients treated with belimumab were generally comparable to patients treated with placebo plus standard therapy. The safety results are consistent with the known profile of belimumab.

Benlysta is currently not recommended for use in severe active lupus nephritis anywhere in the world because it has not been previously evaluated in these patients. Based on these positive phase 3 data, GSK plans to progress regulatory submissions in the first half of 2020 to seek an update to the prescribing information.

The full results will be submitted for future presentation at upcoming scientific meetings and in peer-reviewed publications.

About lupus nephritisSystemic lupus erythematosus (SLE), the most common form of lupus, is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage. In lupus nephritis (LN), SLE causes kidney inflammation, which can lead to end-stage kidney disease. Despite improvements in both diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis.1,2 Manifestations of LN include proteinuria, elevations in serum creatinine, and the presence of urinary sediment.

About BLISS-LNBLISS-LN,which enrolled 448 adult patients, was a phase 3, 104-week, randomised, double-blind, placebo-controlled post-approval commitment study to evaluate the efficacy and safety of IV belimumab 10 mg/kg plus standard therapy (mycophenolate mofentil for induction and maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance, plus steroids) compared to placebo plus standard therapy in adult patients with active lupus nephritis. Active lupus nephritis was confirmed by kidney biopsy during screening visit using the 2003 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria, and clinically active kidney disease.

The primary endpoint PERR was defined as estimated Glomerular Filtration Rate (eGFR) 60 mL/min/1.73m2 or no decrease in eGFR from pre-flare of > 20%; and urinary protein:creatinine ratio (uPCR) 0.7; and not a treatment failure. The most stringent secondary endpoint CRR was defined as eGFR is no more than 10% below the pre-flare value or within normal range; and uPCR < 0.5; and not a treatment failure. ORR was defined as complete, partial or no response.

About Benlysta (belimumab)Benlysta, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. Benlysta does not bind B cells directly. By binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.

The current US and EU indication for Benlysta are summarised below:

In the US, "Benlysta is indicated for the treatment of patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of Benlysta is not recommended in these situations."

Full US prescribing information including Medication Guide is available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Benlysta/pdf/BENLYSTA-PI-MG.PDF

In the EU, "Benlysta is indicated as "add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy."

The Precaution and Warnings for Benlysta includes information that "Benlysta has not been studied in the following adult and paediatric patient groups, and is not recommended: severe active central nervous system lupus; severe active lupus nephritis; HIV; a history of, or current, hepatitis B or C; hypogammaglobulinaenia (IgG < 400mg/dl) or IgA deficiency (IgA < 10 mg/dl); a history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant."

The EU Summary of Product Characteristics for Benlysta is available on: http://www.ema.europa.eu

Benlysta is available as an intravenous and a subcutaneous formulation. The Benlysta subcutaneous formulation is not approved for use in children.

GSK's commitment to immunologyGSK is focused on the research and development of medicines for immune-mediated diseases, such as lupus and rheumatoid arthritis, that are responsible for a significant health burden to patients and society. Our world-leading scientists are focusing research on the biology of the immune system with the aim to develop immunological-based medicines that have the potential to alter the course of inflammatory disease. As the only company with a biological treatment approved for adult and paediatric lupus, GSK is leading the way to help patients and their families manage this chronic, inflammatory autoimmune disease. Our aim is to develop transformational medicines that can alter the course of inflammatory disease to help people live their best day, every day.

Important Safety Information for belimumabPlease consult the full Prescribing Information for all the labelled safety information for Benlysta (belimumab)

Contraindications:Previous anaphylaxis with BENLYSTA.

Warnings and precautions: Not recommended in adult and paediatric groups with severe active central nervous system lupus, severe active lupus nephritis, HIV, history of/current hepatitis B or C, hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl) and patients with a history of major organ transplant or hematopoietic stem/cell/marrow transplant or renal transplant.

Mortality:In adult intravenous (IV) clinical trials, death occurred in 0.8% of patients treated with BENLYSTA and in 0.4% of patients receiving placebo; etiologies included infection, cardiovascular disease, and suicide. In the adult SC clinical trial, death occurred in 0.5% of patients receiving BENLYSTA and in 0.7% of patients receiving placebo; infection was the most common cause of death.

Serious Infections:Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. The most frequent serious infections in adults treated with BENLYSTA IV included pneumonia, urinary tract infection, cellulitis, and bronchitis. Use caution in patients with severe or chronic infections, and consider interrupting therapy in patients with a new infection.

Progressive Multifocal Leukoencephalopathy (PML):Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported in patients with SLE receiving immunosuppressants, including BENLYSTA. If PML is confirmed, consider stopping immunosuppressant therapy, including BENLYSTA.

Hypersensitivity Reactions (Including Anaphylaxis):Acute hypersensitivity reactions, including anaphylaxis (eg, hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea) and death, have been reported, including in patients who have previously tolerated BENLYSTA. Generally, reactions occurred within hours of the infusion but may occur later. Non-acute hypersensitivity reactions (eg, rash, nausea, fatigue, myalgia, headache, and facial edema) typically occurred up to a week after infusion. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. With BENLYSTA SC, systemic hypersensitivity reactions were similar to those in IV trials.

Healthcare providers (HCPs) should monitor patients during and after IV administration and be prepared to manage anaphylaxis; discontinue immediately in the event of a serious reaction. Premedication may mitigate or mask a hypersensitivity response. Advise patients about hypersensitivity symptoms and instruct them to seek immediate medical care if a reaction occurs.

Infusion Reactions:Serious infusion reactions (eg, bradycardia, myalgia, headache, rash, urticaria, and hypotension) were reported in adults. HCPs should monitor patients and manage reactions if they occur. Premedication may mitigate or mask a reaction. If an infusion reaction develops, slow or interrupt the infusion.

Depression and Suicidality:In clinical trials, psychiatric disorders (depression, suicidal ideation and behavior) were reported more frequently in patients receiving BENLYSTA than placebo. In adult trials, psychiatric events reported more frequently with BENLYSTA IV related primarily to depression-related events, insomnia, and anxiety; serious psychiatric events included serious depression and suicidality, including 2 completed suicides. No serious depression-related events or suicides were reported in the BENLYSTA SC trial. Before adding BENLYSTA, physicians should assess patients' risk of depression and suicide and monitor them during treatment. Instruct patients to contact their HCP if they experience new/worsening depression, suicidal thoughts, or other mood changes.

Malignancy:The impact of BENLYSTA on the development of malignancies is unknown; its mechanism of action could increase the risk for malignancies.

Immunization: Live vaccines should not be given for 30 days before or concurrently with BENLYSTA as clinical safety has not been established.

Use With Biologic Therapies or IV Cyclophosphamide:BENLYSTA has not been studied and is not recommended in combination with other biologic therapies, including B-cell targeted therapies, or IV cyclophosphamide.

Adverse Reactions:The most common serious adverse reactions in adults were serious infections: BENLYSTA IV 6.0% (placebo 5.2%), some of which were fatal. Adverse reactions occurring in 3% of adults and 1% more than placebo: nausea 15% (12%); diarrhea 12% (9%); pyrexia 10% (8%); nasopharyngitis 9% (7%); bronchitis 9% (5%); insomnia 7% (5%); pain in extremity 6% (4%); depression 5% (4%); migraine 5% (4%); pharyngitis 5% (3%); cystitis 4% (3%); leukopenia 4% (2%); viral gastroenteritis 3% (1%).

Adverse reactions in pediatric patients aged 5 years receiving BENLYSTA IV were consistent with those observed in adults.

The safety profile observed for BENLYSTA SC in adults was consistent with the known safety profile of BENLYSTA IV with the exception of local injection site reactions.

Pregnancy and lactation:Pregnancy: There are insufficient data in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. After a risk/benefit assessment, if prevention is warranted, women of childbearing potential should use contraception during treatment and for 4 months after the final treatment.

Lactation:No information is available on the presence of belimumab in human milk, the effects on the breastfed infant, or the effects on milk production. Consider developmental and health benefits of breastfeeding with the mother's clinical need for BENLYSTA and any potential adverse effects on the breastfed child or from the underlying maternal condition.

Pediatric Use:The safety and effectiveness have not been established for BENLYSTA IV in patients <5 years of age and for BENLYSTA SC in patients <18 years of age.

Black/African American Patients:In clinical trials there have been mixed results regarding how well BENLYSTA works in this patient population. Consider risks and benefits when prescribing BENLYSTA.

About GSK GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit http://www.gsk.com.

Trademarks are owned by or licensed to the GSK group of companies.

References

GSK enquiries:

UK Media enquiries:

Simon Steel

+44 (0) 20 8047 5502

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Tim Foley

+44 (0) 20 8047 5502

(London)

US Media enquiries:

Evan Berland

+1 215 432 0234

(Philadelphia)

Courtney Dysart

+1 215-237-7431

(Philadelphia)

Analyst/Investor enquiries:

Sarah Elton-Farr

+44 (0) 20 8047 5194

(London)

Danielle Smith

+44 (0) 20 8047 2406

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James Dodwell

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Jeff McLaughlin

+1 215 751 7002

(Philadelphia)

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2018.

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The 2010s will go down in history as a decade of many newsworthy health-related stories, many of which were not good news -- Ebola, measles, antibiotic resistance. But in the years since 2010 there were also many promising discoveries in medicine, life-saving drugs approved, and great strides taken addressing national health crises. Some of these stories will have lasting effects for generations to come.

24/7 Tempo reviewed multiple news archives and dozens of articles published since 2010 to select 15 of the most positive health news stories that made headlines.

Some of the most talked about stories over the last few years have influenced health guidelines, treatment of serious disease, and even government policy.

Reports of significant research developments in the treatment and prevention of chronic and other conditions gave hope to millions of Americans. Some of the good news broke as recently as just a few months ago these are the 15 biggest health topics of 2019.

Click here for 15 of the best health news over the last decade.

CT scans in high risk patients can reduce overall lung cancer mortality

Year: 2011

Category: Diseases

The tremendous effort by researchers and health institutions to develop a cure for cancer over the decades since the legislation for the War on Cancer was enacted in 1971 will likely continue. Any good news on developments are worth noting. The 2011 National Lung Screening Trial showed a reduction in lung cancer mortality of 20% in high risk patients receiving low-dose CT (LDCT) compared to chest X-ray. The CDC recommends that people at high risk of developing lung cancer -- heavy smokers, people who have smoked as recently as 15 years, and people who are 55 years or older -- undergo annual LDCT scans because of potential risks.

In 2016, there were 218,229 new cases of lung cancer, and 148,869 people died from the disease in the United States, according to the CDC. The American Cancer Society estimates 142,670 deaths from lung cancer in 2019. A major reason for the disease's high mortality rate is that the tumor does not typically cause symptoms until it spreads, making early screening especially crucial to improving survival rates.

Blame SUVs: These 9 cars will be killed in 2020

Pass the ketchup, hold the beef: Americans crave Impossible Burger, Beyond Meat in 2020

Melanoma drug approved

Year: 2011

Category: Treatment

After more than a decade of no new potential drugs for melanoma, the deadliest form of skin cancer, the FDA approved vemurafenib, sold under the brand name Zelboraf, in 2011 for patients with metastatic melanoma with the BRAF(V600E) mutation or for those who have tumors that cannot be surgically removed.

Zelboraf was seen as a major development because it can improve melanoma patients' quality of life -- the drug is a simple pill taken twice a day -- and it may extend survival rate. In a trial, the length of time melanoma patients who received Zelboraf lived without the cancer getting worse was almost double the length of patients who did not take the drug.

Since 2011 several drugs have been approved to treat melanoma, and survival rates of this deadly cancer have improved.

Gene editing is now possible

Year: 2012

Category: Technology

Gene editing is the process of changing an organisms DNA. After decades of research around the world, scientists made a major breakthrough with the discovery of clustered repeats of DNA sequences, known as CRISPR.

First described in 2012, CRISPR, or Clustered Regularly Interspaced Short Palindromic Repeats, is the basis for potentially world-changing gene editing technology, or, as some might say, DNA hacking. It may be used to develop treatments for a range of diseases, including cancer and genetic disorders. In 2015, CRISPR was successfully used for the first time to save a life. Two baby girls, 11-month and a 16-month-old, received gene editing treatment to help them fight leukemia.

While the gene-altering tool is bringing revolutionary change to health fields, it has also raised serious ethical concerns. Misuses and inadvertently harmful uses of CRISPR include those for creating designer babies, and causing environmental ripple effects by eliminating disease-spreading insects.

FDA says trans fat should not be considered 'safe'

Year: 2013

Category: Eating

Trans fats, or partially hydrogenated oils, have been widely used for years, most notably in fast foods. Trans fats can raise the levels of "bad" LDL cholesterol, lower the levels of good-for-you HDL cholesterol, and increase the risk of heart disease, the No. 1 killer in the United States. And now they are on their way out.

In 2013, the FDA officially announced trans fats should not be considered safe in human food. In 2015, the agency gave food manufacturers three years to phase out the use of trans fats in their products. The deadline was June 18, 2018, although the FDA granted a one-year extension in the use of artificial trans fats in some cases. The ban will be fully implemented in Jan. 1, 2020.

HIV prevention pill

Year: 2014

Category: Diseases

About 50,000 Americans are diagnosed with HIV every year, according to the CDC. Despite advancements in treatment and years of research into the infection, HIV does not have a cure. In 2014, the CDC issued new guidelines that recommend a pill to people at high risk of HIV as a prevention method. High risk people include gay or bisexual men, injection drug users, and women with an HIV+ partner.

The agency said that the pill, sold under the brand name Truvada, may lower the risk by as much as 90% when taken consistently. Truvada has been used to treat HIV since 2012 when the FDA approved the drug. Truvada contains tenofovir and emtricitabine, which when used in combination with other antiviral medication may keep the HIV virus from establishing a permanent infection.

A new way to treat cavities

Year: 2015

Category: Treatment

In 2015, the FDA approved a painless new way to treat tooth decay called silver diamine fluoride (SDF). It's a liquid that is applied directly to cavities to stop the decay. The FDA gave it a "breakthrough therapy designation" two years later.

As a non-invasive and fairly cheap method (it costs about $20-$25 per tooth), SDF treatment, which must be prescribed by a dentist, can save people a lot of money. About 91% of American adults have dental decay, and about 27% have untreated tooth decay, according to the CDC. Tooth decay is common among kids as well -- it's the most common chronic disease in children between 6 and 11 years of age.

3D printing of human organs

Year: 2015

Category: Technology

3D printing technology has improved considerably over the past few years. (Today, low-budget 3D printers are available for anyone who can spare $100.) The technology has advanced so much that producing fully functional replacement organs from a person's own cells seems like a not-so-distant possibility. Scientists at Harvard's Wyss Institute have grown a heart tissue that beats just like a normal human heart.

Production for treatment is still years away, however. The technique, called sacrificial writing into functional tissue (SWIFT), has not even been tested on mice yet. But if it works, it can be used to print other organs, too, potentially saving the lives of thousands of people who are waiting for an organ transplant.

Immunotherapy and cancer

Year: 2016

Category: Treatment

Cancer immunotherapy was named the 2016 Advance of the Year by the American Society of Clinical Oncology. The therapy is designed to support and boost the immune systems response to cancer cells, rather than targeting the cancer itself. One of the most successful immunotherapies so far is the checkpoint inhibition. It makes the immune response stronger by keeping immune cells activated, which does not normally happen when a person has cancer.

It may take decades until immunotherapy could replace the current standards in cancer treatment of surgery, chemotherapy, and radiation, but currently hundreds of immunotherapy drugs are being tested in clinical trials on people.

Some benefits of immunotherapy include fewer side effects than radiation or chemotherapy, lower risk of relapse, and making other cancer treatments more effective.

Opioid crisis recognized as national public health emergency

Year: 2017

Category: Public health

Every day over 130 people in the United States die from opioid overdose, including pain medication, heroin, and synthetic opioids such as fentanyl, according to the National Institutes of Health. In 2017, President Donald Trump declared the opioid crisis a national public health emergency, giving hope that the federal government's involvement could help fight the worst drug crisis in U.S. history.

The official designation removed certain administrative requirements for accessing federal funds to fight the epidemic, including the use of taxpayers' money to make addiction treatments and naloxone, a life-saving medication that can reverse an opioid overdose, drug, more accessible.

The Department of Health and Human Services has renewed the opioid crisis' status as a national emergency several times since 2017. Money has been used to speed up a survey on whether and how often doctors prescribe opioids and help launch anti-addiction programs quicker, according to the a 2018 report by the Government Accountability Office.

Early-stage Alzheimer's treatment

Year: 2019

Category: Diseases

Currently, there is no treatment for Alzheimer's disease, the sixth leading cause of death in the United States. Pharmaceutical companies and universities have tried to tackle different aspects of the neurodegenerative disorder, but to no avail. Until just a few months ago.

Biogen, a biotechnology company, announced in October 2019 it would ask the FDA to approve its Aducanumab drug as first treatment for early Alzheimer's disease. The company said that patients in the early stages of the disease who were treated with a high dose of the drug experienced significant improvements in memory, orientation, and language. If Aducanumab is approved, it will be one of a handful of drugs approved to treat the disease.

Smoking rates at all-time low

Year: 2018

Category: Habits

The short and long-term health problems smoking causes have been well-documented for decades. Today cigarette smoking among U.S. adults is at an all-time low -- 13.7% in 2018, according to the CDC.

While smoking regular cigarettes is down, smoking e-cigarettes is on the rise. About 37% of 12th graders reported vaping in 2018, compared with 28% in 2017. A recent Gallup survey found that 20% of 18- to 29-year-olds vape regularly, more than twice the national average for all age groups.

There has been a recent outbreak of lung injury associated with the use of e-cigarettes. At least 47 deaths and 2,290 lung injuries have been confirmed by the CDC as a result of vaping as of Nov. 20, 2019. The agency has identified vitamin E acetate, an additive in some THC-containing e-cigarettes, as the likely cause for the lung injuries.

Cystic fibrosis treatment approved by FDA

Year: 2019

Category: Treatment

About 30,000 Americans live with cystic fibrosis, a fairly common genetic disease that affects the lungs and other organs, limiting one's ability to breathe as the disease progresses. About 1,000 new cases are diagnosed every year.

The FDA approved in 2019 what it called a "new breakthrough" therapy to treat the condition. The medication, sold under the name Trikafta, is available to patients who are 12 years or older and have the F508del mutation, the most common cystic fibrosis mutation. It is found in 90% of the people living with the disease. The treatment can increase the life expectancy of patients, which is now around 44 years.

Second HIV patient goes into remission

Year: 2019

Category: Diseases

A second person since HIV was identified in the 1980s has been said to be in sustained remission. The patient, who was treated in London, has not been given antiretroviral therapy for 18 months, and the virus has remained undetectable. The good news comes more than a decade after the Berlin patient, known as the first person to have been cured from the infection. Both patients received a stem cell transplant.

HIV, the virus that causes AIDS, is one of the most serious global health challenges. Almost 38 million people live with HIV worldwide, according to the World Health Organization. Just over 60% are receiving treatment.

Blood test detects breast cancer 5 years early

Year: 2019

Category: Diagnoses

Even though deaths from breast cancer have declined, the disease remains the second leading cause of cancer death among women in the United States, according to the CDC. More than 40,000 women die from it a year.

Improved rates of early detection have helped drive up survival rates. A recent British study offers hope that the condition could now be detected five years before there are any clinical signs of it. The new method is a blood test that identifies the body's immune response to antigens produced by tumor cells. The test may be available in clinics in about five years.

Finding a cure for arthritis

Year: 2019

Category: Treatment

2019 has been an exciting year in the field of health technology and scientific research. In addition to such technological developments as organ printing and gene editing, recent research has shown promise for a cure for arthritis. Millions of people suffering from joint inflammation -- from osteoarthritis, for example, which is the most common form of arthritis -- may be helped.

A recent study published in the Science Advances journal has found that "cartilage in human joints can repair itself [...] to regenerate limbs." The body was previously believed to be unable to do so. People have a molecule that helps with joint tissue repair, and that molecule is more active in ankles and less active in knees and hips. The findings can help develop treatments that may prevent, slow, or even reverse arthritis.

24/7 Wall Street is a USA TODAY content partner offering financial news and commentary. Its content is produced independently of USA TODAY.

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Overall score: 85/100

Tested August 2019

This face mask is formulated with ingredients such as ovine placenta and Phyto stem cells, a blend that claims to repair the skin and boost the production of collagen and elastin. It aims to leave skin hydrated, firmer and looking younger overnight these effects should be long-lasting.

250.00

Available from: net-a-porter.com

As many as 91% of our testers agreed that this product delivered on its claims. It left skin feeling more hydrated by morning and the effects were long-lasting.

It plumped and firmed the skin, especially around the neck and dcolletage. Our testers also noted improvements to the appearance of eye bags and fine lines around the eyes. The face mask absorbed, blended nicely and left the skin feeling soft. The panel described it as an intensive product, which reduced the size of pores and left the complexion smoother and more even.

All product information provided by the manufacturer is correct at time of publication.

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MZ Skin Replenish and Restore Overnight Face Masque Review - goodhousekeeping.com

Skin Stem Cells Comments Off on MZ Skin Replenish and Restore Overnight Face Masque Review – goodhousekeeping.com | December 18th, 2019

Company closes $5.6 million in funding and secures distinguished board of directors as it seeks to empower individual health ownership with personalized biological analysis and storage

GoodCell ("LifeVault Bio"), the personal biobanking company with the health indicators to inform actionable next steps in your health journey, today announced it has secured a $2.6 million price round under LifeVault Bio and a $3 million convertible note, and brought on renowned technology executive Anthony Bay as its newest board member. The capital will be used to expand GoodCell Diagnostics, the companys commercial application, as it pioneers a cell quality test to measure the DNA damage to somatic cells over time, as well as fuel the formation of strategic partnerships across the healthcare and life sciences sectors, and grow the team at its headquarters in Waltham, Mass.

GoodCell helps individuals take control of their health through personalized biobanking of cells, DNA and blood plasma, with the belief that medical science will continue to progress, bringing forth new ways of preventing, detecting and treating diseases. Research continues to prove that cells are an essential starting material for the treatments of tomorrow. DNA and plasma are widely validated as critical information sources for monitoring and tracking health risk and informing lifestyle decisions. GoodCell aims to empower individuals with personal health information and storage resources to take full advantage of breakthrough medical science as it emerges.

"Stem cells are among the most promising areas of medical research because they are the starting materials from which all other cells originate," said Brad Hamilton, co-founder and chief science officer at GoodCell. "Some of these cells, specifically induced pluripotent stem (iPS) cells which can be derived from a persons own skin or blood, can be programmed to produce virtually any type of cell in the human body. This versatility has made them an instrumental tool, helping scientists understand and fight some of the biggest health threats of our time, such as Parkinsons disease, Type 1 diabetes and heart disease. GoodCell exists to help people preserve their access to these potentially lifesaving cells."

After GoodCell sends members a sample collection kit to their doorstep, they are prompted to schedule a convenient blood-draw with a certified phlebotomist, who then safely packages and ships the sample for processing. Once received, GoodCell isolates and preserves three components of the blood sample: cells, DNA and blood plasma. The DNA sample is then tested to inform genetic predisposition to disease, such as metabolic, neurologic and cardiac disorders, as well as certain cancers. Armed with deep insight into a members biology, the GoodCell Dashboard displays their health information as a comprehensive overview, designed to inform the next best action in their health journey. Samples are stored in a state-of-the-art, FDA-registered CLIA/CAP certified lab and biorepository that is trusted by larger biotechnology companies and the National Institutes of Health. Since it is the change in health indicators that indicates risk, recurrent sampling is possible to enable measuring the trajectory of change in plasma components or DNA. Since the samples belong to GoodCell members, they can decide whether or not to share their information with their doctor or allow researchers to use it in clinical studies.

"To me, GoodCell represents the ultimate in personalized medicine. Individuals can now have their own biobank and their own biodata. These wont be owned by a hospital or in the case of your cells, by no one at all. These will be stored for you, accessible only on your instruction. As new tests come online or as cells become a broader therapy source, you will be able to tap into your own earlier, preserved self in the form of your blood," said David Scadden, MD, co-founder and chair of the Scientific Advisory Board at GoodCell. "Imagine two scenarios. First, a new blood test becomes available for Alzheimers disease. You get the test, but just like current tests for things like prostate cancer, it is only meaningful in light of how it is changing. Your doctor will likely advise waiting months or a year to re-test. With a GoodCell sample, we envision the test can be done on your blood from a previous time. Then you can know how things are changing without the prolonged wait and the anxiety it engenders. Second, lets say the stem cell field delivers on the therapies it is currently testing for diabetes, heart failure, Parkinsons disease and macular degeneration. Those therapies will likely be as cells derived from you. Would you want those to be from you at a younger age since we know our cells accumulate genetic damage with age? I think most people would, and would want cells from their blood, which the bones have shielded from radiation, rather than their skin as is currently done. GoodCell will have those blood cells for you and has shown they can be made into stem cells (iPSC) with high efficiency."

Story continues

GoodCell is focused on continuing to grow its customer base and building up its talent pool at its new headquarters in Waltham, Mass. The company, which is poised to expand its headcount in early 2020, will also be exploring strategic partnerships with cell and gene therapy companies and interest groups that could benefit from GoodCell members deciding whether to opt-in to allow access to stored cells, DNA and plasma. GoodCell will also continue to recruit pioneers in business, science and technology to its board positions. Most recently, it welcomed Anthony Bay, former Global Head of Digital Video for Amazon and a veteran senior executive at other technology powerhouses, including Apple and Microsoft.

"Ive devoted my career to creating scalable and differentiated technology platforms and unique digital experiences in many industries, and am excited to lend my expertise and perspectives to GoodCell," said Bay. "I am delighted to play a role in helping the GoodCell team scale and expand to match the size of our opportunity to change peoples lives."

Bay joins an already robust and diverse group of consumer technology and life science leaders, including John Goscha, Lucidity Lights founder and Chairman of the Board of Directors, Finally Light Bulb Company founder and entrepreneur; David Scadden, MD, professor of medicine at Harvard Universitys Department of Stem Cell and Regenerative Biology; Daniel Marshak, principal consultant in therapeutics, diagnostics and medical devices; Avi Ellman, managing partner of Delta Global Investment Services; and Trevor Perry, co-founder and chief executive officer at GoodCell.

"Up until now, existing genetics offerings can only go so far as to inform your genetic makeup. GoodCell is taking that a step further today by combining genetics, health indicator testing and personal biobanking into one solution, and then turning this information right back to the individual so they can understand the story of their health and leverage actionable data at any age," said Perry. "We are taking advantage of leading scientific innovation to help people take control of their health through personalized biobanking of cells, DNA, and blood plasma, and we believe the tremendous amount of support we received during this initial funding round will further allow us to be a true enabler of and partner in this process. Our goal is to set a new standard for personal biobanking as an individual health milestone, and our mission is to ensure our members feel confident and prepared to own their aging experience, and we look forward to accelerating our efforts in the months ahead."

For more information about GoodCell, visit https://www.goodcell.com. To order your starter kit, visit https://www.goodcell.com/shop/.

About GoodCell

GoodCell helps you take control of your health through personalized biobanking of cells, DNA and blood plasma. Leveraging the best science, the technology provides health indicators for a comprehensive and proactive approach to self-care. Through the GoodCell Dashboard, the company informs the next best action in your health journey, offering access for you and for your doctor to actionable data and insights that relate to all aspects of your health through genetic reporting and blood analysis. Driven by mounting evidence in support of cellular therapy and united in the belief that you should be empowered to take control of your health, GoodCell is led by a founding team of scientific advisors with a diverse set of medical research and clinical expertise. By backing up your starting materials, GoodCell is setting a new standard of personal biobanking today for a healthier future. Learn more at: https://www.goodcell.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191217005485/en/

Contacts

PAN CommunicationsStaci Didner407 734 7325Goodcell@pancomm.com

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GoodCell Oversubscribes Upon Debut, Fueling Expansion of Health Tracking and Personal Biobanking Services; Adds Former Amazon and Microsoft Executive...

Skin Stem Cells Comments Off on GoodCell Oversubscribes Upon Debut, Fueling Expansion of Health Tracking and Personal Biobanking Services; Adds Former Amazon and Microsoft Executive… | December 18th, 2019

Though the research was intended as a proof of concept, the experimental gene therapy slowed tumour growth and prolonged survival in mice with gliomas, which constitute about 80% of malignant brain tumours in humans.

The technique takes advantage of exosomes, fluid-filled sacs that cells release as a way to communicate with other cells.

The research was carried out by scientists at the Ohio State University and published in the journal Nature Biomedical Engineering.

While exosomes are gaining ground as biologically friendly carriers of therapeutic materials because there are a lot of them and they dont prompt an immune response the trick with gene therapy is finding a way to fit those comparatively large genetic instructions inside their tiny bodies on a scale that will have a therapeutic effect.

This new method relies on patented technology that prompts donated human cells such as adult stem cells to spit out millions of exosomes that, after being collected and purified, function as nanocarriers containing a drug.

When they are injected into the bloodstream, they know exactly where in the body to find their target even if its in the brain.

Senior study author L. James Lee, professor emeritus of chemical and biomolecular engineering at Ohio State University, said: Think of them like Christmas gifts: the gift is inside a wrapped container that is postage paid and ready to go. This is a Mother Nature-induced therapeutic nanoparticle.

In 2017, Lee and colleagues made waves with news of a regenerative medicine discovery called tissue nanotransfection (TNT). The technique uses a nanotechnology-based chip to deliver biological cargo directly into skin, an action that converts adult cells into any cell type of interest for treatment within a patients own body.

By looking further into the mechanism behind TNTs success, scientists in Lees lab discovered that exosomes were the secret to delivering regenerative goods to tissue far below the skins surface.

The scientists placed about one million donated cells on a nano-engineered silicon wafer and used an electrical stimulus to inject synthetic DNA into the donor cells. As a result of this DNA force-feeding, as Lee described it, the cells need to eject unwanted material as part of DNA transcribed messenger RNA and repair holes that have been poked in their membranes.

The electrical stimulation had a bonus effect of a thousand-fold increase of therapeutic genes in a large number of exosomes released by the cells, a sign that the technology is scalable to produce enough nanoparticles for use in humans.

Essential to any gene therapy is knowing what genes need to be delivered to fix a medical problem. For this work, the researchers chose to test the results on glioma brain tumours by delivering a gene called PTEN, a cancer-suppressor gene. Mutations of PTEN that turn off that suppression role can allow cancer cells to grow unchecked.

For Lee, founder of Ohio States Center for Affordable Nanoengineering of Polymeric Biomedical Devices, producing the gene is the easy part. The synthetic DNA force-fed to donor cells is copied into a new molecule consisting of messenger RNA, which contains the instructions needed to produce a specific protein. Each exosome bubble containing messenger RNA is transformed into a nanoparticle ready for transport, with no blood-brain barrier to worry about.

The testing in mice showed the labelled exosomes were far more likely to travel to the brain tumours and slow their growth compared to substances used as controls.

Because of exosomes safe access to the brain, Lee said, this drug-delivery system has promise for future applications in neurological diseases such as Alzheimers and Parkinsons disease.

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Mother Nature provides new gene therapy strategy to reverse disease - Health Europa

Skin Stem Cells Comments Off on Mother Nature provides new gene therapy strategy to reverse disease – Health Europa | December 18th, 2019

A Wisconsin boy with a uncommon illness that causes his pores and skin to blister on the slightest contact has now been recognized with most cancers.

Charlie Knuth, 13, from Darboy, was adopted by his mother and father after he was deserted on the hospital as a child, reported WFRV.

He suffers from epidermolysis bullosa (EB), a uncommon genetic tissue dysfunction that causes the pores and skin to blister and burst, leaving uncooked sores which might be inclined to infections.

Charlie has lived most of his life wrapped in bandages and has to take particular baths on daily basis to deal with his sores and maintain them from getting contaminated.

However the teenager is now going through a brand new battle after being recognized earlier this 12 months with lymphoma, a most cancers of the immune system.

Charlie Knuth, 13, from Darboy, Wisconsin, was born with a uncommon pores and skin dysfunction. Pictured: Charlie, proper, along with his father, Kevin

The dysfunction, often known as epidermolysis bullosa, causes the pores and skin to blister and burst on the slightest contact and leaves uncooked sores. Pictured: Charlie within the hospital)

Victims of EB are lacking sort VII collagen, a protein that enables the highest layer of pores and skin to bind with the underside layers.

The slightest motion can causes the pores and skin to instantly and constantly fall off.

The dysfunction could be very uncommon, and is estimated to happen in 20 newborns per a million reside births within the US, based on Stanford Kidss Hospital.

About 87 % of youngsters born with EB die throughout their first 12 months of life.

There isnt any remedy for EB so remedy goals at stopping blisters from changing into contaminated.

Charlies mom, Trisha Knuth, stated she and his father, Kevin, have tried a number of measures to assist deal with her son, together with lotions, lotions and gloves.

He is additionally undergone two stem cell transplants, during which new sheets of pores and skin grown and graft over the injuries.

In 2017, Charlie underwent surgical procedure to revive the usage of his palms, which had been degenerating because of his situation.

With no surgical procedure, his palms can be lined in scar tissue.

The scar tissue will really construct up between all the net areas between every finger, and the palms, and develop proper excessive of the hand so persons are left with simply nothing however mitts, Trisha advised WFRV.

In keeping with the station, throughout the surgical procedure, pores and skin was taken from Charlies thighs to make use of on his palms.

Titanium rods had been additionally inserted intoevery of his fingers, and saved there for 5 weeks, to stop them from curling into his palms.

Charlie (left and proper) was deserted at a hospital earlier than being adopted by his present mother and father. Earlier this month, he was recognized with lymphoma, a most cancers of immune system cells

His mother and father stated theyre touring to Minnesota to determine what stage his most cancers is at and what remedy hell bear. Pictured: Charlie, proper, along with his mom, Trisha

On Wednesday, Trisha posted on Fb that her son was recognized with lymphoma.

Lymphoma is most cancers that begins within the lymphocytes, that are immune system cells that struggle an infection.

There are two kinds of the most cancers, Non-Hodgkins and Hodgkins, nevertheless its not clear which kind Charlie has.

Indicators and signs embody swelling of the lymph nodes, fever, fatigue, shortness of breath and sudden weight reduction.

Therapy varies and may embody chemotherapy, radiation remedy and immunotherapy.

Its estimated that 82,310 folks will likely be recognized with lymphoma in 2019 and that 20,970 will die, based on the American Most cancers Society.

Within the Fb put up, Trisha wrote: My head is spinning and my coronary heart is breaking. My candy boy.

Charlies mom added the household will likely be touring to Minnesota so his most cancers can get staged and so they can assess remedy choices.

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Boy abandoned at the hospital after being born with butterfly skin disease diagnosed with cancer - Herald Publicist

Skin Stem Cells Comments Off on Boy abandoned at the hospital after being born with butterfly skin disease diagnosed with cancer – Herald Publicist | December 18th, 2019

The ODAC discussions were based on the supplemental Biologics License Application (sBLA), currently under priority review at the FDA, seeking approval of KEYTRUDA monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, NMIBC with carcinoma in-situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy (removal of bladder). This application is based on results from the Phase 2 KEYNOTE-057 trial.

The positive vote from todays ODAC meeting supports the potential for KEYTRUDA in certain patients with high-risk, non-muscle invasive bladder cancer, who currently have limited non-surgical treatment options approved by the FDA, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. We are encouraged by todays productive discussion and look forward to working with the FDA as they continue their review of our supplemental application for KEYTRUDA in this patient population.

The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA is not bound by the committees guidance but takes its advice into consideration. Merck anticipates a Prescription Drug User Fee Act (PDUFA), or target action date, in January 2020, based on priority review.

About Bladder Cancer

Bladder cancer begins when cells in the urinary bladder start to grow uncontrollably. As more cancer cells develop, they can form a tumor and spread to other areas of the body. Bladder cancers are described based on how far they have invaded into the wall of the bladder. NMIBC occurs when the cancer has not grown into the main muscle layer of the bladder. It is estimated that more than 80,000 new cases of bladder cancer will be diagnosed in 2019 in the United States. Approximately 75% of patients with bladder cancer are diagnosed with non-muscle invasive bladder cancer (NMIBC). For high-risk NMIBC patients who are BCG-unresponsive with persistent or recurrent disease, treatment guidelines recommend radical cystectomy, a surgery to remove the entire bladder that often requires removal of other surrounding organs and tissues. In men, removal of the prostate is common, and in women, surgeons may also remove the uterus, fallopian tubes, ovaries and cervix, and occasionally a portion of the vagina.

About KEYNOTE-057

The filing was based on data from KEYNOTE-057 (NCT02625961), a Phase 2, multicenter, open-label, single-arm trial in 102 patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumors who were ineligible for or had elected not to undergo cystectomy (Cohort A). In this study, BCG-unresponsive high-risk NMIBC is defined as persistent disease despite adequate BCG therapy, disease recurrence after an initial tumor-free state following adequate BCG therapy, or T1 disease following a single induction course of BCG. Patients received KEYTRUDA 200 mg every three weeks until unacceptable toxicity, persistent or recurrent high-risk NMIBC or progressive disease. Assessment of tumor status was performed every 12 weeks, and patients without disease progression could be treated for up to 24 months. The major efficacy outcome measures were complete response (as defined by negative results for cystoscopy [with transurethral resection of bladder tumor (TURBT)/biopsies as applicable], urine cytology, and computed tomography urography [CTU] imaging) and duration of response.

About KEYTRUDA (pembrolizumab) Injection, 100mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,000 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patients likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency), thyroid function (prior to and periodically during treatment), and hyperglycemia. For hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or 4 hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Adverse reactions occurring in patients with hepatocellular carcinoma (HCC) were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 34) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 34) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. Laboratory abnormalities (Grades 34) that occurred at a higher incidence were elevated AST (11%) and hyperglycemia (19%).

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

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FDA Oncologic Drugs Advisory Committee (ODAC) Recommends KEYTRUDA (pembrolizumab) for the Treatment of Certain Patients with High-Risk, Non-Muscle...

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Aspen Neuroscience, a new biotech company, has raised $6.5 million to develop cell therapies for Parkinsons disease using patients own cells.

The company was co-founded by renowned stem cell scientists Jeanne F. Loring, PhD, and Andres Bratt-Leal, PhD, and initially supported by Summit for Stem Cell, a non-profit organization that provides a variety of services for Parkinsons patients.

Parkinsons hallmark motor symptomsinclude tremor, slowness of movement (bradykinesia), stiffness (rigidity), uncontrollable movements (dyskinesia), and poor balance.

As the disease progresses, patients typically need to gradually increase their dopaminergic therapeutic dose for maximum benefit. Even after that they might sometimes experience reappearance or worsening of symptoms due to diminishing effects of dopaminergic therapy, known was off periods.

Importantly, dopaminergic therapy is delivered to areas of the brain other than the striatum, a key motor control region severely affected in Parkinsons disease. Because of the therapys off-target behavior, patients also may experience side effects such as hallucinations or cognitive impairment.

Aspen wants to combine its expertise in stem cell biology, genomics and neurology and develop the first autologous (self) stem cell-based therapy for Parkinsons disease.

In this type of cell therapy, a patients own cells (usually skin cells) are reprogrammed back into a stem cell-like state, which allows the development of an unlimited source of almost any type of human cell needed, including dopamine-producing neurons, which are those mainly affected by this disorder.

Because these cells are derived from patients, they do not carry the risk of being rejected once re-implanted, eliminating the need for immunosuppressive complementary therapies, which carry serious side effects such as infections and possibly limiting therapeutic potential.

In theory, replacing lost dopaminergic neurons with new stem cell-derived dopamine-producing ones could potentially ease or reverse motor symptoms associated with the disease.

Aspen is developing a restorative, disease modifying autologous neuron therapy for people suffering from Parkinsons disease, Howard J. Federoff, MD, PhD, Aspens CEO, said in a press release.

We are fortunate to have such a high-caliber scientific and medical leadership team to make our treatments a reality. Our cell replacement therapy, which originated in the laboratory of Dr. Jeanne Loring and was later supported by Summit for Stem Cell and its President, Ms. Jenifer Raub, has the potential to release dopamine and reconstruct neural networks where no disease-modifying therapies exist, Federoff said.

The companys lead product (ANPD001) is undergoing investigational new drug (IND)-enabling studies for the treatment of sporadic Parkinsons disease. Aspen experts also are developing a gene-editing treatment (ANPD002) for familial forms of Parkinsons, starting with the most common genetic variant in the GBAgene, which provides instructions to make the enzyme beta-glucocerebrosidase.

The new seed funding round was led by Domain Associates and Axon Ventures, with additional participation from Alexandria Venture Investments, Arch Venture Partners, OrbiMed and Section 32, according to the press release.

With over three years of experience in the medical communications business, Catarina holds a BSc. in Biomedical Sciences and a MSc. in Neurosciences. Apart from writing, she has been involved in patient-oriented translational and clinical research.

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Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.

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Aspen Neuroscience Receives $6.5M for Parkinson's Stem Cell Therapy - Parkinson's News Today

Skin Stem Cells Comments Off on Aspen Neuroscience Receives $6.5M for Parkinson’s Stem Cell Therapy – Parkinson’s News Today | December 16th, 2019

LOUISVILLE, Colo., Dec. 16, 2019 /PRNewswire/ --French Transit, LLC brands MyChelle Dermaceuticalsand CRYSTAL Deodoranttoday announced plans to continue and expand existing partnerships with several key charities and non-profits in 2020. These initiatives are part of an extensive corporate social responsibility program spearheaded by French Transit CEO Martin Floreani.

"It is no longer enough to be 'clean' or 'cruelty-free' in a passive manner," says Floreani. "We also need to be proactive in our stewardship of the planet and its resources. We need to put our time, money and full commitment behind our mission which we define as Clean & Caring." Floreani will be a key panelist during a Natural Products Expo West education seminar in March dedicated to helping other companies define and grow their own corporate social responsibility programs.

"Brands need to embrace cruelty-free research processes, but our company goes beyond by supporting organizations like The Gentle Barn that foster vegan and cruelty-free lifestyles." The Gentle Barn is a non-profit organization dedicated to ending animal cruelty and animal testing that is unfortunately still a reality in the beauty and personal care category. It provides sanctuary for abused and neglected animals and allows inner-city and at-risk children to interact with them, promoting respect and responsibility. MyChelle and CRYSTAL brands supported the Gentle Barn's "Gentle 12 program" for the month of August, and served as title sponsors for the charity's 20th Anniversary Gala in September and have confirmed their renewed commitment for 2020.

MyChelle Dermaceuticals will also continue and expand its support of The Coral Restoration Foundation, the world's largest nonprofit marine-conservation organization dedicatedto restoring our planet's coral reefs to a healthy state. MyChelle was one of the first cosmetic manufacturers to reject marine-toxic ingredients, including oxybenzone, octinoxate, butylparaben, retinyl palmitate and 4-methylbenzylidene camphor. "MyChelle is dedicated not only to creating reef-friendly sun care but also helping organizations such as the Coral Restoration Foundation to preserve and grow reefs," said Floreani. Last July, the company donated 1% of all net proceeds from online sales to the Foundation. This year MyChelle will continue its support of the Coral Restoration Foundation but is also working to be the first brand in its category to incorporate ocean recycled plastic into its packaging.

French Transit is also a recurring sponsor of Breast Cancer Prevention Partners (BCPP), an organization that raises awareness of toxic chemicals used in many personal care products. In 2019, during Breast Cancer Awareness Month, French Transit donated 1% of net sales from their websites to the organization, a commitment that will be repeated in 2020.

"We look forward to building upon our work with these amazing and truly impactful organizations in 2020," said Floreani. "And we are excited and proud to be a leader in a growing community of personal care companies who actively go beyond their claims to foster positive change and real results."

http://www.mychelle.com (PRNewsFoto/MyChelle Dermaceuticals)" alt="Founded in 2000, the Colorado-based skin care company is credited as the first to successfully develop and market natural skin care products using a combination of anti-aging peptides, plant stem cells, and clinically proven dermatological ingredients. Learn more at http://www.mychelle.com (PRNewsFoto/MyChelle Dermaceuticals)">

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SOURCE French Transit

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French Transit Brands to Expand their Corporate Social Responsibility Programs in 2020 - Benzinga

Skin Stem Cells Comments Off on French Transit Brands to Expand their Corporate Social Responsibility Programs in 2020 – Benzinga | December 16th, 2019

However, we may finally have a solution to the First Worlds most enduring problem, baldness, as according to new research, it is certainly possible to create new hair follicles when theyve redeposited themselves to the foot of your shower, through the application of stem-cell technology and 3D printing.

There is a caveat, as the results of the technique are not necessarily long-lasting. When you try to clone hair cells, over time they dedifferentiate and stop producing hair, says Robert Bernstein, a dermatologist in Manhattan who specialises in hair transplantation. For a long time, no one could figure out why. But researchers gradually solved the problem. Over the past few years, they noticed that cells spread out when theyre cultured; the follicular structure essentially melts away. The epiphany was that if you can keep the cells together in their teardrop shape so they continue to signal each other, they continue to grow into hair follicles, Bernstein says.

The next step is to create hair farms, according to an entrepreneur who has started such a thing. Stemson Therapeutics is, per The Atlantic, growing hair from stem cellsnot fetal, but stem cells derived from a persons own skin or bloodand implanting hair follicles rich with dermal papillae into the space around a persons old, shrunken, dormant follicle.

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Science makes baldness optional (if you can afford it) - The Big Smoke Australia

Skin Stem Cells Comments Off on Science makes baldness optional (if you can afford it) – The Big Smoke Australia | December 15th, 2019

For the first time ever, Israeli scientists in Tel Aviv made a 3D printed artificial heart using a patients own cells," proclaims a Washington Post story headlined Researchers create 3D printed heart on April 17 this year.

In the scientific paper published two days earlier, the Israeli scientists describe how they made a bioink out of heart cells and other materials from a patient, and then bioprinted the tissue in the shape of a tiny heart, which was kept alive in a nutrient solution. Their paper makes it clear that this 3D printed heart could not function like a real heart. But the way the research that was projected in media shows how the idea of 3D printed organs is hyped.

Biotechnology has made significant advances, but its still a long way from creating organs that can be transplanted into people. The vasculaturethe network of blood vessels that feeds the organis a challenge.

Stem cell engineering to grow all the cells of an organ in a personalised way to avoid rejection by the recipients immune system is another challenge. And finally, researchers will have to show that a lab organ will work with all the other organs in a human body.

At the same time, the development of 3D bioprinters in the last few years has raised the prospects of making tissues and organs in a more affordable and consistent way because of the speed and precision of the machines. Advances in related fields like nanotechnology and gene editing are also pushing the needle.

These are exciting times, but for startups rushing into this nascent field with huge potential, its as important to be prudent as brave. One way is to go after low hanging fruit instead of the holy grail.

Shift to clinical use

Something like skin is easier to translate into a clinical setting," says Alok Medikepura Anil, director and co-founder of Bengaluru-based 3D bioprinting startup Next Big Innovation Lab (NBIL), which has made human skin in the lab. The skin has good regenerative properties and most of the function of bioprinted skin is to keep infections away, provide nutrition for skin to regenerate and stop the scarring of wounds. Replicating this is easier than replicating the function of a critical organ such as the heart."

This approach contrasts with that of another Bengaluru-based 3D bioprinting startup Pandorum Technologies, founded in 2011 by two researchers at Indian Institute of Science. Pandorum first tried its hand with liver tissue and more recently announced that it had bio-engineered corneal tissue.

Organ tissue for clinical use will require FDA and other approvals. So thats a very expensive proposition," says angel investor Venkat Raju, who took an interest in Pandorum but eventually made a bet on NBIL whose proprietary Innoskin also has non-clinical use in cosmetics testing.

The regulatory environment is evolving. This year, FDA released an RMAT (regenerative medicine and advanced therapy) policy that includes tissue engineering. The FDA wants to fast-track tissue-engineered products if they have a lot of benefits," says Pooja Venkatesh, NBIL co-founder.

Raju feels that startups like NBIL gaining traction and validation could bridge the current gap between academic research and business.

Theres tonnes of research happening across the globe on bioprinting. But universities are struggling to commercialize their research. The fact that NBIL is getting receptive audiences in academia is because they see an opportunity to push their research out."

The Wake Forest Institute of Regenerative Medicine in the US is one of the leading institutions for research in this field. Researchers there are growing tissues for over 40 different areas of the body. They were the first to transplant a lab-grown organ into a 10-year-old patient.

Made-to-order organs

Dr Anthony Atala, who is now the director of the institute, had taken a piece of the boys bladder and grown a new one in the lab over the course of two months. The lab-grown bladder was then transplanted into the patient.

That boy, Luke Massella, went on to become the captain of his school wrestling team. Pretty much I was able to live a normal life after that," Massella, who is now 28, said in a recent interview on BBC.

Stories like that of Massella stoke excitement over futuristic scenarios where you could get made-to-order organs. But researchers admit that there are many unsolved problems in tissue engineering before complex organs like the heart, kidney and liver can be bioprinted. The crash of well-funded San Diego 3D bioprinting startup Organovo, which hit a brick wall in commercializing liver tissue, reminds us to keep the hype in check.

Sumit Chakraberty is a contributing editor with Mint. Write to him at chakraberty@gmail.com.

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Cutting through the hype to get to bioprinted human tissue - Livemint

Skin Stem Cells Comments Off on Cutting through the hype to get to bioprinted human tissue – Livemint | December 15th, 2019

Aspen Neuroscience, a new San Diego biotech company working on stem cell treatment for Parkinsons disease, has come out of stealth mode and raised $6.5 million to pursue clinical testing for its therapy.

Co-founded by well-known stem cell scientist Jeanne Loring, Aspen Neuroscience proposes creating stem cells from modified skin cells of Parkinsons patents via genetic engineering.

The stem cells, which can become any type of cell in the body, then would undergo a process that makes them specialize into dopamine-releasing neurons.

People with Parkinsons lose a large number up to 50 percent at diagnosis of specific brain cells that make the chemical dopamine.

Without dopamine, nerve cells cannot communicate with muscles and people are left with debilitating motor problems.

Once these modified skin cells have been engineered to specialize in producing dopamine, they can be transplanted into the Parkinsons patient to restore the types of neurons lost to the disease.

The reason we called it Aspen is because l was raised in the Rocky Mountain states, said Loring. When there is a forest fire in the Rockies, the evergreens are wiped out but the aspens are the fist that regenerate after the burn. So it is a metaphor for regeneration.

Aspen still has a long way to go before its proposed therapy would be available to Parkinsons patients. It has been meeting with the U.S. Food and Drug Administration to provide animal trial data and other information in hopes of getting permission to start human clinical trials.

But the company expects the earliest it would get the go-ahead from FDA to start human trials would be 2021.

Loring has been working on the therapy for eight years. She is professor emeritus and founding director of the Center for Regenerative Medicine at the Scripps Research Institute.

Loring co-founded the 20-employee company with Andres Bratt-Leal, a former post-doctoral researcher in Lorings lab at Scripps.

Joining them as Aspens Chief Executive is Dr. Howard Federoff, former vice chancellor for health affairs and chief executive of the University of California Irvine Health System.

Federoff said the company is the only one pursuing the use of Parkinsons patients own cells as part of neuron replacement therapy.

Aspens proprietary approach does not require the use of immuno-suppression drugs, which can be given when transplanted cells come from another person and perhaps limit the effectiveness of the treatment.

Aspens approach is a therapy that is likely to benefit from the fact that your own cells know how to make the best connections with their own target cells in the brain, even in the setting of Parkinsons disease, said Federoff. So when transplanted it is able to set back the clock on Parkinsons.

In addition to Aspens main therapy, it is researching a gene-editing treatment for forms of Parkinsons common in certain families.

Aspens research work up to now has been supported by Summit for Stem Cell, a non-profit on which provides a variety of services for people with Parkinsons disease.

The new seed funding round was led by Domain Associates and Axon Ventures, with additional participation from Alexandria Venture Investments, Arch Venture Partners, OrbiMed and Section 32.

Aspens financial backing, combined with its experienced and proven leadership team, positions it well for future success, said Kim Kamdar, a partner at Domain Associates. Domain prides itself on investing in companies that can translate scientific research into innovative medicines and therapies that make a difference in peoples lives. We clearly see Aspen as fitting into that category, as it is the only company using a patients own cells for replacement therapy in Parkinsons disease.

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Aspen Neuroscience gets funding to pursue personalized cell therapy for Parkinsons disease - The San Diego Union-Tribune

Skin Stem Cells Comments Off on Aspen Neuroscience gets funding to pursue personalized cell therapy for Parkinsons disease – The San Diego Union-Tribune | December 14th, 2019

A Campus meeting in November reviewed the arguments for and against donor conception, and the sometimes difficult ethical arguments raised by the prospect of a donor-conceived child. 'Artificial' sperm cells derived from testicular tissue or stem cells may resolve some of those arguments.

The problem is especially acute in cancers diagnosed in prepubertal boys in whom there are no sperm cells available for storage. Their only option for future fatherhood in the face of cancer treatment is adoption or donor sperm. And this, added Goossens, is not an exceptional problem. Incidence rates are around 17 cases per 100,000 population, with leukemia and CNS tumours the most commonly diagnosed. So the usual pathway to fertility preservation in these young cases is for the oncologist to warn of the risk to future fertility from the cancer treatments and refer to the fertility clinic. Biopsy of testicular tissue, of course, must be performed before any radio- or chemotherapy.

Goossens described two experimental techniques, spermatogonial stem cell retrieval and transplantation, and homotopic tissue grafting. The danger in the former procedure is a risk of introducing malignancy, so banked tissue must be free of malignant contamination. Experiments in mouse-to-mouse models have demonstrated spermatogenesis from tissue grafting, and most recently fully functional conception and delivery in a non-human primate (Grady). Similarly, experiments in mouse models with spermatogonial stem cell transplantation have so far proved efficient, with spontaneous pregnancy already possible.

Of course, the objective of this impressive experimental work is not merely a resolution to the question of genetic continuity in couples faced with third-party donation, but the future fertility and long-term quality of life of so many unfortunate young boys. Advances in cancer treatment have led to the increased survival of all children with cancer, and with it a new imperative for the restoration of their fertility. Not all cancer treatments cause complete testicular damage, but around one-third of children having treatment for pediatric cancers will end up infertile. Following the proof-of-concept study which saw the birth of Grady - in which testicular samples removed from prepubertal monkeys was frozen, thawed and regrafted under scrotal skin - the research group declared that their next logical step, with safety and feasibility apparent, is human trials.

1. Fayomi AP, Peters K, Sukhwani M, et al. Autologous grafting of cryopreserved prepubertal rhesus testis produces sperm and offspring. Science 2019; 363: 1314-1319.

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CAMPUS: EGG DONATION - Artificial sperm cells to remove the genetic worries of sperm donation - ESHRE

Skin Stem Cells Comments Off on CAMPUS: EGG DONATION – Artificial sperm cells to remove the genetic worries of sperm donation – ESHRE | December 12th, 2019

The idea of a cell therapy for Parkinsons disease starts out simple: Symptoms of the progressive disease are largely driven by the deaths of dopamine-producing neurons found deep within the brain. With lower levels of the neurotransmitter come the characteristic tremors, rigidity and slow movements.

By replacing those lost nerve cells with new dopamine producers, researchers hope to renew the brains connection to the bodys muscles and improve a persons overall motor function.

But in the brain, everything becomes more complicated. On top of the risk of immune system rejection that comes with any kind of living tissue transplant, its important to make sure the implanted cells function correctly and do not pick up any dangerous genetic mutations as they grow.

How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDC

CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management.

Now, a new company, Aspen Neuroscience, aims to tackle both obstacles at once.

First, the startup hopes to avoid any harmful immune reactions by using a patients own cells as a starting point. Then, Aspen plans to implement a rigorous quality control program employing whole genome sequencing and artificial intelligence to make sure the cells stay in line as theyre processed and readied for the procedure.

And to do it, the San Diego-based company is starting out with $6.5 million in seed money plus an impressive roster of names.

They are led by neurology researcher Howard Federoff, previously vice chancellor for health affairs and CEO of the University of California, Irvine health system as well as the executive dean of medicine at Georgetown University. Hes joined by Aspen co-founder and stem cell scientist Jeanne Loring, founding director and professor emeritus of the Center for Regenerative Medicine at the Scripps Research Institute.

Meanwhile, the seed round was led by Domain Associates and Axon Ventures with additional backing from Alexandria Venture Investments, Arch Venture Partners, OrbiMed and Section 32.

Aspen looks to combine its expertise in stem cell biology, genomics and neurology to offer the first autologous cell therapy for Parkinsons diseasewhile others in the space have pursued allogeneic routes, or therapies derived from donors other than the patient.

The process starts with a culture of the patients skin cells, which are then genetically induced to become pluripotent stem cellsor cells capable of differentiating into any other cell type in the body. These are then chemically nudged further to transform into precursor versions of the dopamine-producing neurons, which are typically found in the midbrain and regions responsible for the movement of limbs.

We can say without any equivocation that we can produce the population of cells necessary to transplant, and in a short enough period of time to have a potential beneficial impact on the evolution of the disease, said Federoff, who has also served as chair of the NIHs Recombinant DNA Advisory Committee and helped lead the U.S. Parkinsons Disease Gene Therapy Study Group.

We envisage that this will set back the clock on patients who have Parkinsons, unlike any other therapy that we know of, he told FierceMedTech in an interview.

The number of cells needed would be much smaller compared to other cell therapies and cancer treatments. The healthy human brain contains only about 200,000 dopamine-producing nerve cells, split between its two hemispheres, while patients with Parkinsons disease have lost about 50% or more of those neurons.

Aspen aims to evaluate two doses: one that aims to replace about 60% to 65% of a persons normal cell complement and another larger treatment, Federoff said.

Those smaller doses, as well as starting with a patients donor cells, help make the treatment safer to produce by requiring fewer steps. Each cycle of cell division and multiplication to increase their numbers carries the risk of introducing genetic mutations.

As the cells are grown, they are consistently evaluated with data-driven techniques pioneered by Lorings laboratory. Using whole genome RNA sequencing, Aspen will match the cells up at every stage with a genetic barcode taken from each patient at the start. This will allow them to look for changes, duplications or deletions in the pluripotent stem cell genome.

If the cells harbor mutations that are cancer drivers, we don't want to put those into people, Loring said. The only way is to check the sequencing before we transplant them.

The cells used in the transplant procedure arent fully grown; as neuron progenitors, they mimic the development steps seen in the brain of a growing fetus after theyre placed in the body as they wire themselves up to other neural structures and begin to form new networks of their own.

We anticipate that they will manufacture and release dopamine in a manner that is consistent with synaptic neurotransmission and the process of communicating from cell-to-cell, said Federoff. They will take up dopamine from synapses when it has done its business, bring it back into the cell, and prepare it for another synaptic release.

These are not just dopamine pumps, theyre real neurons, added Loring. They will genuinely replace the cells that have been lost in every way.

Aspen plans to pursue two courses of therapy, for the two major types of Parkinsons disease. Their lead candidate is for idiopathic, or sporadic Parkinsons, while their second is a CRISPR-edited version of the therapy designed to address one of the diseases most common genetic mutations, linked to about 5% of cases.

This would not only aim to restart dopamine production in this orphan indication, but also restore the damaged enzyme GBA, which is seen as an underlying cause. Federoff and Loring expect their sequencing-based quality check system will also help catch any off-target edits linked to the use of CRISPR-Cas9.

The company has yet to secure permission from the FDA to officially launch clinical trials, but the agency has signed off on Aspens plans to prepare a trial-ready cohort of Parkinsons disease patients in the meantime. This would include the initial stages of recruitment and testing, including the selection of patients capable of having their skin cells made into pluripotent stem cells.

After it receives its go-ahead from the FDA, Aspen plans to hit the ground running,enrolling at least 176 participants in a phase 1/2 study that includes a randomized stage to determine clinical benefits.

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By turning stem cells into brain cells, Aspen Neuroscience hopes to rewind the progress of Parkinson's disease - FierceBiotech

Skin Stem Cells Comments Off on By turning stem cells into brain cells, Aspen Neuroscience hopes to rewind the progress of Parkinson’s disease – FierceBiotech | December 12th, 2019

How do you know if your skin is dry? For starters, it feels rough to the touch and, in extreme cases, it may start flaking and you may even feel a tearing sensation.

The good news is that dryskin can be easily avoided, and the most efficient way to hydrate parched skin is with a hydrating sheet mask. All it takes is 15 to 20 minutes and youre on your way to plumped, glowing skin.

These days, hydration sheet masks are loaded with so much extra goodness vitamins, minerals, amino acids,organic acids, plant stem cells andpeptidesthat gointo the formulas that these can also help fight wrinkles, eliminate dark spots and lighten skin tone.

CHARLOTTE TILBURY INSTANT MAGIC FACIAL DRY SHEET MASK, S$76

Yes, this is a dry mask that you can get at Sephora. The magic all comes from the warmth of your skin: The bio-mimetic vector delivery system turns a combo of ingredients (crocus bulb extract, plant stem cells, peptides and vitamin B3) from solid to liquid.

Wear the dry mask by looping the hoops over each ear then simply activate the formula by massaging upwards to move the mask into place. After 15 minutes, take it off then gently tap the remaining essence into the skin. Youll soon notice a glow that is similar to the one you get after a super shiok facial.

But dont throw away the mask just yet the dry formula is engineered for reuse. In fact, you can use it three more times. Just slip it back (the formula side facing inward) into the resealable foil pouch for when you need it next. So really, thats four masks for the price of one.

UTENA PURESA SHEET MASK HYALURONIC ACID 5S, S$12.90

You can pick this up at Watsons. There are five masks to a pack and each one combines the benefits of hyaluronic acid and royal jelly extract, infused with a gel-like essence that works to hydrate skin like a jelly mask. To make the most of it, first smoothen the jelly bits onto the face before placing the sheet over the face.

But theres more: Peek into the packaging and youll see lots of jelly bits left. Apply these remaining bits anywhere else you want to hydrate. We personally like to spread it over the neck, the back of the palms and even the elbows. Yes, it also works as a body hydration gel.

SK II FACIAL TREATMENT MASK, S$127

Love SK IIs Facial Treatment Essence? Then youll love this sheet mask because its drenched with so much Facial Treatment Essence that it feels as if youve dunked your face into a tub of Pitera.

It contains 50 micro-nutrients like vitamins, minerals, amino acids and organic acids to condition skin's natural functions. Twenty minutes is all it takes to rehydrate, clarify complexion and have crystal clear skin.

LA MER THE TREATMENT LOTION HYDRATING MASK, S$45

Each sheet mask is infused with a full ounce of La Mers liquid energy skin hydrator and its equipped with Japanese skin-hugging technology that delivers a concentrated surge of healing hydration directly onto the skin to nourish and soften fine lines.

STARSKIN RED CARPET READY HYDRATING BIO-CELLULOSE SECOND SKIN FACE MASK, S$18

Another mask you can pick up at Sephora is one with a difference. Instead of prepping your face, you prep the mask massage the still-closed sachet to distribute the serum liquid evenly before opening.

The exclusive Bio Cellulose sheet a thin biodegradable microfibre is infused with a delicious cocktail of coconut juice, Amino acids and brown algae that work together to strengthen the skin barrier and promote moisture retention. Dull and dehydrated skin doesnt stand a chance.

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Got dry skin but no time for a facial? These hydration sheet masks are just as good - CNA

Skin Stem Cells Comments Off on Got dry skin but no time for a facial? These hydration sheet masks are just as good – CNA | December 12th, 2019

Materials science company W. L. Gore & Associates Inc. (Newark, DE) has announced a joint venture with the Mayo Clinic (Rochester, MN) to further develop a therapeutic system using stem cells and bio-absorbable scaffolds to treat a condition affecting patients with Crohns disease. Avobis Bio, based in Delaware, will draw on the expertise of scientists and medical professionals from both organizations to build on the encouraging results of an investigational treatment for perianal fistulas.

A debilitating condition that affects patients with Crohns disease, perianal fistulas are painful tunneling wounds connecting the anus to the skin, explained Gore in a press release. Few healing options exist, and patients endure multiple surgeries and ongoing risk of life-threatening complications, said Gore.

"Perianal fistulas are truly life-altering for Crohn's patients, and treatment options have eluded gastroenterologists and surgeons for years," added William Faubion Jr., MD, a Mayo Clinic gastroenterologist who specializes in inflammatory bowel diseases.

The innovative treatment involves harvesting a patients own mesenchymal stem cells, which then are populated on Gore's bioabsorbable polymer scaffold and surgically implanted in the fistula. A phase I clinical trial showed that 76% of patients healed within a year. If this outcome is validated in a larger trial, Gore said that it would dramatically exceed outcomes achieved with existing treatments.

This project is the initial focus of Avobis Bio, which describes its overall mission as an exploration of the use of mesenchymal stem cells combined with enabling bioabsorbable scaffolds that enhance the effectiveness of the cells in stimulating the body to heal.

Delivering a patients mesenchymal stem cells on a synthetic scaffold that biodegrades over time may be a first-of-its-kind medical therapy, noted Joe Carlson, a reporter at the Minneapolis-based Star Tribune reporting on the joint venture. If successful, Avobis Bio may one day offer a variety of tissue and organ-repair therapies combining Mayo's stem cell expertise and Gore's medical materials, he wrote.

Gore is perhaps best known to the public for its Gore-Tex outerwear, but the privately held $3.7 billion engineering and manufacturing firm sells products in an array of industries, including a line of medical devices designed to repair nonnatural holes in body organs, added Carlson. Mayo has used Gore-made devices for many years.

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Gore, Mayo Clinic team up to deliver breakthrough medical therapies - Plastics Today

Skin Stem Cells Comments Off on Gore, Mayo Clinic team up to deliver breakthrough medical therapies – Plastics Today | December 12th, 2019

This article highlights some of the most recent drug target discoveries that could be used to develop and design a treatment for pancreatic cancer.

Scientists investigating pancreatic cancer have identified new targets which, with further research, could be the basis for developing future therapies. Listed below are five of the most recent target discoveries, in order of their journal publication dates, with the newest first.

Scientists at the Queen Mary University of London, UK and Zhengzhou University, China have developed a personalised vaccine system that may be able to delay the onset of pancreatic cancer.

Cells taken from mice, mutated chemically into pancreatic cancer cells and then infected with Adenovirus (AdV) as a prime or Vaccinia virus (VV) as a boost, create a vaccine product. The virus kills the cancerous cells in such a way that their antigens are released and are therefore able to prime the immune system to prevent pancreatic cancer returning.

Injection of the virus-infected cells into mice destined to develop pancreatic cancer doubled their survival rate, compared to their unvaccinated counterparts. The vaccine also delayed the onset of the condition in these mice.

Using cells from the recipient of the vaccine enables the immune system to respond to the exact antigens seen in tumour cells of the individual, resulting in a vaccine regime tailored to them.

Through this international collaboration, we have made progress towards the development of a prophylactic cancer vaccine against pancreatic cancer, said Professor Yaohe Wang, leader of the study, from Queen Mary University of London and the Sino-British Research Centre at Zhengzhou University in China.

Researchers at Sanford Burnham Prebys Medical Discovery Institute in the US have identified that a combination of two anti-cancer compounds, already approved for use to treat other cancers, shrank pancreatic tumours in mice.

Our study identifies a potential treatment combination that can immediately be tested against these aggressive tumours. We are already meeting with oncologists at Oregon Health & Science University, US to discuss how to advance this discovery into clinical evaluation, explained Dr Zeev Ronai, a professor in Sanford Burnham Prebys Tumor Initiation and Maintenance Program, also senior author of the study.

Scientists used L-asparaginase to starve pancreatic tumours of asparagine, an amino acid required by cells for protein synthesis. However, the tumour cells did not die, instead switching on a stress response pathway whereby they could produce asparagine themselves. Scientists then used an MEK inhibitor to block the stress response pathway, causing the pancreatic tumour to shrink.

L-asparaginase is already US Food and Drug Administration (FDA) approved to treat leukaemias and similarly the MEK inhibitor is approved for the treatment of solid tumours, including melanoma skin cancer.

This research lays the basis for the inhibition of pancreatic tumour growth by a combined synergistic attack based on asparagine restriction and MAPK signalling inhibition, says Dr Eytan Ruppin, chief of the Cancer Data Science Library at the National Cancer Institute (NCI) and co-author of the study.

Scientists from the Max Planck Institute for Biology of Ageing, Germany have identified that YME1L, a protease in the membrane of mitochondria, is activated when a cell uses glycolysis to produce energy anaerobically.

scientists were able to reduce tumour growth by switching off the glycolysis signalling pathway in the mitochondria

Cells adapt to oxygen deficiency by switching their energy supply to glycolysis, which ferments sugar without oxygen. This switch is often necessary in old age, as the cells in the body become poorly supplied with oxygen and nutrients.

Cancer cells can also face this problem; prior to angiogenesis, tumours are poorly perfused and so the tissue is deprived of oxygen. Oxidative stress in tumours drives the switch-on of multiple pathways. This includes the glycolysis pathway that alters the behaviour of the mitochondria to provide tumour cells with energy despite being starved of oxygen.

Scientists found that the YME1L protease is activated during the conversion to glycolysis. YME1L appears altered and breaks down various proteins in the organelles, preventing the formation of new mitochondria and causing the remaining organelles to change their metabolism. This process eventually stops as YME1L begins to degrade itself at high activity.

Researchers examined cancer cells originating from patients with pancreatic tumours and were able to reduce tumour growth by switching off the glycolysis signalling pathway in the mitochondria, with reproducible results both in the petri dish and in pancreatic tumours in mice.

There is currently no treatment available for pancreatic cancer. I believe that this protease can be a very interesting therapeutic target because we have seen that the signalling pathway is also active in human patients with pancreatic cancer, explained Thomas Langer, the Max Planck Director, continuing: However, there are no known substances that have an effect on this protease.

Researchers at the Crick Institute have identified cancer stem cells as a driver of pancreatic cancer growth. These cells can metastasise and differentiate into different tumour types to continue the spread of cancer.

Cancer stem cells appear at all stages of cancer growth so being able to identify where they are present could be vital in both targeting cancer and developing new treatments, according to the researchers. Analysis of gene expression in the cancer stem cells identified a protein, CD9, is present on tumour surfaces during development and when it is more established. This protein could therefore be used as a marker to help locate these cells.

A further development of the study established that this protein is not just a marker of cancer stem cells, but also promotes their malignant behaviour. By altering the amount of CD9 in tumour cells in mice, researchers found that reduced levels of this protein caused smaller tumours to form and increasing levels of CD9 created more aggressive cells able to form large tumours quickly.

These cells are vital to pancreatic cancer and if even just a few of them survive chemotherapy, the cancer is able to bounce back. We need to find effective ways to remove these cells and so stop them from fuelling cancer growth. However, we need more experiments to validate the importance of CD9 in human pancreatic cancer, says Victoria Wang, lead author and member of the Adult Stem Cell Laboratory at the Crick Institute.

A look into cancer stem cell metabolism also revealed CD9 increases the rate tumour cells take up glutamine, an amino acid which helps provide energy for cancer growth.

Now we know this protein is both linked to cancer stem cells and helps cancer growth, this could guide the development of new treatments that are targeted at the protein and so cut off the supply of glutamine to cancer stem cells, effectively starving the cancer, says Axel Behrens, corresponding author and group leader in the Adult Stem Cell Laboratory at the Crick Institute.

Scientists at Tel Aviv University, Israel have found that PJ34, a small molecule, causes human pancreatic cancer cells to self-destruct. The researchers tested PJ34 on xenografts (transplants) of human pancreatic tumours in mice.

this mechanism also exists in other types of cancer and therefore the treatment could be valuable for use on those resistant to current therapies

The mice were treated with a molecule called PJ34, which is permeable in the cell membrane but affects human cancer cells exclusively. This molecule causes an anomaly during the duplication of human cancer cells, provoking their rapid cell death. Thus, cell multiplication itself resulted in cell death in the treated cancer cells, explains Professor Malca Cohen-Armon, project lead at Tel Aviv Universitys Sackler Faculty of Medicine.

The treatment consisted of daily PJ34 injections for 14 days and four weeks later there was a relative drop of 90 percent in the number of cancer cells within the tumours of the mice. Cohen-Armon also noted there were no adverse side-effects observed in the mice.

This mechanism similarly exists in other types of cancer and therefore the treatment could be valuable for use on those resistant to current therapies. The molecule PJ34 is being tested in pre-clinical trials according to FDA regulations before clinical trials begin.

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Five recent drug target discoveries for pancreatic cancer - Drug Target Review

Skin Stem Cells Comments Off on Five recent drug target discoveries for pancreatic cancer – Drug Target Review | December 12th, 2019

Im hairythats just fact, and its something Ive always been aware of. Ill never forget being in summer camp as a kid, wearing shorts every day and becoming very aware that my legs were much hairier than those of the girls around me. Now, Im no longer ashamed of being hairyIve actually come to embrace it. But in the past two decades, Ive gotten very acquainted with epilators, including laser hair removal.

I got my first laser hair removal treatment two years ago. It seemed like everyone was getting it done, but as a black woman, I knew I wasnt everyone. For brown skin, laser hair removal isnt a spur-of-the-moment decision, a process that should be approached through a Groupon or the local nail salon (yes, some nail salons actually perform laser hair removal). For us, the process can be a bit more expensive and tedious, and should be approached with the utmost caution.

Why? Well, lasers target pigment, and due to the high content of melanin in our skin, risks of discoloration and hyper-pigmentation are astronomically higher. So thats why, according to Chris Karavolas, owner of Romeo And Juliette Laser Hair Removal, darker skin requires a completely different laser all together, and operators with much more experience. Darker skin complexions need to be careful because not all centers have the right lasers for dark skin, and even if they do they do, many do not have enough experience in treating dark skin, he says.

When it comes to those specialized lasers, there are two options. Its important to treat with an Nd:YAG laser, such as the Candela GentleYAG or GentleMax Pro, says Anne Chapas, M.D., medical director of Union Square Laser Dermatology in New York City. The wavelength of a YAG laser goes deeper into the skin than a diode laser and is less absorbed by the surrounding skin pigment, so it more successfully treats the stem cells of the hair follicle. Additionally, more treatments may be required than for fairer skin: Expect to receive at least six sessions, Chapas says.

Knowing all these things, I went into laser hair removal with cautious optimism. I chose to treat my Brazilian areayears of improper hair removal had left me with ingrown and severe discoloration, to the point that my wax lady refused to continue treating me because my skin had gotten so irritated. I was sure that I wanted to continue being hair-free down there, so I decided to get laser hair removal on my vagina area. I was nervous heading into my first appointment, so I made sure to ask the aesthetician at Romeo & Juliette in-depth questions about her experience with dark skin, as well as requesting to see photos of previous clients and inquiring about a patch test. Then, it was showtime.

I like to think that I have a pretty high pain tolerance. However, laser removal certainly made me question that belief. I wont lie and say that it didnt hurt. It did. It felt like being snapped, hard, by rubber bands, but it was quick, and the results I saw were almost immediate. I was advised to shave right before the treatment, in order to give the laser immediate access to the hair follicle, and because, well, nobody likes the smell of burning hair. After about 10 minutes, I was sent on my way and advised to come back in another six weeks. Laser hair removal requires a strict schedule and works in conjunction with the hair cycle for optimal results. Every appointment thereafter was just as easy, and now, completely through all six of my sessions, my hair is almost completely gone, with the occasional stubble appearing here and there.

So how do you know if your skin will need one of these specialized lasers? Different ethnicitiesregardless of skin tonereact differently to lasers. Your skin may appear to be a 3 or 4 on the Fitzpatrick scale, but if youre, say, Latin or Asian, it could react to the laser as a 6 would, Dr. Chapas says. So be sure that youre only going to facilities that have operators trained in dermatology, and are skilled enough to differentiate your skin tone.

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What its like to get laser hair removal as a black woman - Yahoo Lifestyle

Skin Stem Cells Comments Off on What its like to get laser hair removal as a black woman – Yahoo Lifestyle | December 12th, 2019