Worldwide Regenerative Medicine Industry to 2025 – Featuring Allergan, Amgen and Baxter International Among Others – PRNewswire
By daniellenierenberg
DUBLIN, Nov. 9, 2020 /PRNewswire/ -- The "Regenerative Medicine Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2020-2025" report has been added to ResearchAndMarkets.com's offering.
The global regenerative medicine market grew at a CAGR of around 16% during 2014-2019. Regenerative medicine refers to a branch of biomedical sciences aimed at restoring the structure and function of damaged tissues and organs. It involves the utilization of stem cells that are developed in laboratories and further implanted safely into the body for the regeneration of damaged bones, cartilage, blood vessels and organs. Cellular and acellular regenerative medicines are commonly used in various clinical therapeutic procedures, including cell, immunomodulation and tissue engineering therapies. They hold potential for the effective treatment of various chronic diseases, such as Alzheimer's, Parkinson's and cardiovascular disorders (CVDs), osteoporosis and spinal cord injuries.
The increasing prevalence of chronic medical ailments and genetic disorders across the globe is one of the key factors driving the growth of the market. Furthermore, the rising geriatric population, which is prone to various musculoskeletal, phonological, dermatological and cardiological disorders, is stimulating the market growth. In line with this, widespread adoption of organ transplantation is also contributing to the market growth. Regenerative medicine minimizes the risk of organ rejection by the body post-transplant and enhances the recovery speed of the patient.
Additionally, various technological advancements in cell-based therapies, such as the development of 3D bioprinting techniques and the adoption of artificial intelligence (AI) in the production of regenerative medicines, are acting as other growth-inducing factors. These advancements also aid in conducting efficient dermatological grafting procedures to treat chronic burns, bone defects and wounds on the skin. Other factors, including extensive research and development (R&D) activities in the field of medical sciences, along with improving healthcare infrastructure, are anticipated to drive the market further. Looking forward, the publisher expects the global regenerative medicine market to continue its strong growth during the next five years.
Competitive Landscape:
The report has also analysed the competitive landscape of the market with some of the key players being Allergan PLC (AbbVie Inc.), Amgen Inc., Baxter International Inc., BD (Becton, Dickinson and Company), Integra Lifesciences Holdings Corporation, Medtronic plc, Mimedx Group Inc., Novartis AG, Osiris Therapeutics Inc. (Smith & Nephew plc) and Thermo Fisher Scientific Inc.
Key Questions Answered in This Report:
Key Topics Covered:
1 Preface
2 Scope and Methodology 2.1 Objectives of the Study2.2 Stakeholders2.3 Data Sources2.3.1 Primary Sources2.3.2 Secondary Sources2.4 Market Estimation2.4.1 Bottom-Up Approach2.4.2 Top-Down Approach2.5 Forecasting Methodology
3 Executive Summary
4 Introduction4.1 Overview4.2 Key Industry Trends
5 Global Regenerative Medicine Market5.1 Market Overview5.2 Market Performance5.3 Impact of COVID-195.4 Market Forecast
6 Market Breakup by Type6.1 Stem Cell Therapy6.1.1 Market Trends6.1.2 Market Forecast6.2 Biomaterial6.2.1 Market Trends6.2.2 Market Forecast6.3 Tissue Engineering6.3.1 Market Trends6.3.2 Market Forecast6.4 Others6.4.1 Market Trends6.4.2 Market Forecast
7 Market Breakup by Application7.1 Bone Graft Substitutes7.1.1 Market Trends7.1.2 Market Forecast7.2 Osteoarticular Diseases7.2.1 Market Trends7.2.2 Market Forecast7.3 Dermatology7.3.1 Market Trends7.3.2 Market Forecast7.4 Cardiovascular7.4.1 Market Trends7.4.2 Market Forecast7.5 Central Nervous System7.5.1 Market Trends7.5.2 Market Forecast7.6 Others7.6.1 Market Trends7.6.2 Market Forecast
8 Market Breakup by End User8.1 Hospitals8.1.1 Market Trends8.1.2 Market Forecast8.2 Specialty Clinics8.2.1 Market Trends8.2.2 Market Forecast8.3 Others8.3.1 Market Trends8.3.2 Market Forecast
9 Market Breakup by Region9.1 North America9.1.1 United States9.1.1.1 Market Trends9.1.1.2 Market Forecast9.1.2 Canada9.1.2.1 Market Trends9.1.2.2 Market Forecast9.2 Asia Pacific9.2.1 China9.2.1.1 Market Trends9.2.1.2 Market Forecast9.2.2 Japan9.2.2.1 Market Trends9.2.2.2 Market Forecast9.2.3 India9.2.3.1 Market Trends9.2.3.2 Market Forecast9.2.4 South Korea9.2.4.1 Market Trends9.2.4.2 Market Forecast9.2.5 Australia9.2.5.1 Market Trends9.2.5.2 Market Forecast9.2.6 Indonesia9.2.6.1 Market Trends9.2.6.2 Market Forecast9.2.7 Others9.2.7.1 Market Trends9.2.7.2 Market Forecast9.3 Europe9.3.1 Germany9.3.1.1 Market Trends9.3.1.2 Market Forecast9.3.2 France9.3.2.1 Market Trends9.3.2.2 Market Forecast9.3.3 United Kingdom9.3.3.1 Market Trends9.3.3.2 Market Forecast9.3.4 Italy9.3.4.1 Market Trends9.3.4.2 Market Forecast9.3.5 Spain9.3.5.1 Market Trends9.3.5.2 Market Forecast9.3.6 Russia9.3.6.1 Market Trends9.3.6.2 Market Forecast9.3.7 Others9.3.7.1 Market Trends9.3.7.2 Market Forecast9.4 Latin America9.4.1 Brazil9.4.1.1 Market Trends9.4.1.2 Market Forecast9.4.2 Mexico9.4.2.1 Market Trends9.4.2.2 Market Forecast9.4.3 Others9.4.3.1 Market Trends9.4.3.2 Market Forecast9.5 Middle East and Africa9.5.1 Market Trends9.5.2 Market Breakup by Country9.5.3 Market Forecast
10 SWOT Analysis10.1 Overview10.2 Strengths10.3 Weaknesses10.4 Opportunities10.5 Threats
11 Value Chain Analysis
12 Porters Five Forces Analysis12.1 Overview12.2 Bargaining Power of Buyers12.3 Bargaining Power of Suppliers12.4 Degree of Competition12.5 Threat of New Entrants12.6 Threat of Substitutes
13 Price Analysis
14 Competitive Landscape14.1 Market Structure14.2 Key Players14.3 Profiles of Key Players14.3.1 Allergan PLC (AbbVie Inc.)14.3.1.1 Company Overview14.3.1.2 Product Portfolio 14.3.1.3 Financials 14.3.1.4 SWOT Analysis14.3.2 Amgen Inc.14.3.2.1 Company Overview14.3.2.2 Product Portfolio14.3.2.3 Financials 14.3.2.4 SWOT Analysis14.3.3 Baxter International Inc.14.3.3.1 Company Overview14.3.3.2 Product Portfolio 14.3.3.3 Financials 14.3.3.4 SWOT Analysis14.3.4 BD (Becton, Dickinson and Company)14.3.4.1 Company Overview14.3.4.2 Product Portfolio 14.3.4.3 Financials 14.3.4.4 SWOT Analysis14.3.5 Integra Lifesciences Holdings Corporation14.3.5.1 Company Overview14.3.5.2 Product Portfolio 14.3.5.3 Financials 14.3.5.4 SWOT Analysis14.3.6 Medtronic Plc14.3.6.1 Company Overview14.3.6.2 Product Portfolio 14.3.6.3 Financials14.3.6.4 SWOT Analysis14.3.7 Mimedx Group Inc.14.3.7.1 Company Overview14.3.7.2 Product Portfolio14.3.7.3 Financials 14.3.8 Novartis AG14.3.8.1 Company Overview14.3.8.2 Product Portfolio 14.3.8.3 Financials14.3.8.4 SWOT Analysis14.3.9 Osiris Therapeutics Inc. (Smith & Nephew plc)14.3.9.1 Company Overview14.3.9.2 Product Portfolio14.3.10 Thermo Fisher Scientific Inc.14.3.10.1 Company Overview14.3.10.2 Product Portfolio 14.3.10.3 Financials14.3.10.4 SWOT Analysis
For more information about this report visit https://www.researchandmarkets.com/r/gcpeaa
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Worldwide Regenerative Medicine Industry to 2025 - Featuring Allergan, Amgen and Baxter International Among Others - PRNewswire
Three-month-old Winnipeg boy in need of bone marrow transplant to survive – CTV News Winnipeg
By daniellenierenberg
WINNIPEG -- A baby boy in Winnipeg is in need of a bone marrow transplant to survive, but he has yet to find a donor.
Three-month-old Boston has a rare disease called hemophagocytic lymphohistiocytosis HLH, a rare auto-inflammatory condition with his immune system.
His mother Simone Jannetta, who is a nurse at Grace Hospital, said they need someone who is of mixed race to donate stem cells.
Thats the only way to cure this, she said.
In the meantime, hes just receiving chemotherapy and steroids to help keep him well until then."
Jannetta said the reason they are having difficulty finding a match is because they need someone half Filipino and half Caucasian, and there are not many mixed-race donors currently in the Canadian and worldwide stem cell registries.
A TOUGH ROAD FOR FAMILY DEALING WITH HEALTH ISSUES
This is not the first time the family has dealt with a child facing health issues over the last few years.
When Jannettas daughter and Bostons older sister Beatrix was seven-months-old she presented to the emergency department with a fever and low blood counts. After a bone marrow biopsy, they learned she had a rare condition called autoimmune neutropenia.
So her immune system is not well either, shes very susceptible to infection too, Jannetta said.
Weve had a lot of back and forth with the hospital through herits been a tough road for us.
Anyone in Canada who wants to register to see if they are a match for Boston can go to the Canadian Blood Services website and look up the stem cell registry.
Boston also has his own link where you can register. The Canadian Blood Services will then mail you a kit with a swab, which you can send back once completed.
Its that simple, Jannetta said.
Youre put on the registry and Boston can then match with somebody.
For anyone who is thinking about registering to become a stem cell donor, Jannetta wants them to know they could save somebodys life.
Its not hard, theres no obligation follow through even if you do register, she said.
Theres just such a small representation of ethnically-diverse people on the registry and I just feel like everybody deserves a chance.
- With files from CTVs Nicole Dube.
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Three-month-old Winnipeg boy in need of bone marrow transplant to survive - CTV News Winnipeg
Reynoldsburg man makes unusual birthday wish: ‘I wanted to save someone’s life’ – 10TV
By daniellenierenberg
Troy McKinley donated stem cells to help a stranger with blood cancer.
Think about your birthday wish this year? Did it involve saving someone's life?
A Reynoldsburg man's wish did.
Thirty-five-year-olf Troy McKinely wanted to make sure his birthday wish made a difference in someone else's life.
I wanted to do something big if possible. I've never donated blood before I don't even like needles, he said.
Two years ago, he decided he wanted to make his birthday more about gifts, and instead give the gift of life.
I thought it would be great to save a life so what can I do to help, he said
He found DKMS, the world's largest bone marrow and blood stem cell donor center.
The company sent him a swab kit and he waited to see if he would be a match. Two and a half years later, he was notified that his stem cells matched a patient who was diagnosed with blood cancer.
It was kind of like 'wow this is big. I don't know this person. I don't know anything about him or her.' It's kind of amazing feeling that it could be better for somebody else, he said.
McKinley said it only took a few hours to give the needed stem cells that doctors would later implant to the unknown patient.
I'm hoping that this gentleman I helped is feeling better for it and helped him in some way. Maybe it didn't give him everything back but he has some more time and we all want more time in the world so hopefully, it helped him, he said.
Time, we can all use more of it, but how many of us take the time to think about how we can give others more days on this earth.
It was a birthday wish McKinley says he'd do again knowing his kindness gave a stranger something more valuable than anything.
I think it's amazing to save someone's life. It's an incredible experience, he said.
About DKMS
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Reynoldsburg man makes unusual birthday wish: 'I wanted to save someone's life' - 10TV
Protective protein could help keep blood young and healthy – New Atlas
By daniellenierenberg
A new study led by the University of Edinburgh and Queen Mary University of London has identified a protein that plays a crucial role in protecting the bodys blood stem cells from damage during infection, a finding that could lead to new ways to slow down the aging process.
Hematopoietic stem cells (HSCs) are found in bone marrow, and from there they produce other blood and immune cells. When an infection strikes the body, HSCs are known to ramp up production to fight it off but thats raised some questions for scientists in the past. In particular, how do they protect themselves from damage while working overtime?
We know that inflammatory pathways induced by infection force blood stem cells to rapidly produce immune cells to help combat infections, says Kamil Kranc, corresponding author of the study. However, these pathways can eventually exhaust stem cells or cause their premature aging, and it is important to understand how this can be stopped.
In the new study, the researchers identified a protein called YTHDF2 that seems to be responsible for this important job. When an infection arises, the HSCs produce far more immune cells, but at the same time that triggers inflammatory processes that can damage the stem cells. The study found that the YTHDF2 protein regulates genes that control those inflammatory processes, protecting the stem cells from premature aging.
To investigate the role of YTHDF2, the team engineered mice to be deficient in the protein, then administered a chemical that acts like a viral infection. Sure enough, the mices HSCs appeared to suffer chronic inflammation, altering the production of different blood cell types. Interestingly, the blood of these young animals began to resemble that of much older mice.
The new study seems to agree with previous reports that blood transfusions from young animals to older ones can improve the health of the recipient, and even slow the progression of diseases like Alzheimer's. As such, the team says that future work could investigate whether manipulating levels of YTHDF2 may be a potential anti-aging treatment.
The research was published in the Journal of Experimental Medicine.
Source: University of Edinburgh
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Protective protein could help keep blood young and healthy - New Atlas
Her favorite part of research was the patients, so she switched to primary… – Bothell-Kenmore Reporter
By daniellenierenberg
Some people live by the adage, if it aint broke, dont fix it. When Dr. Adewunmi (Ade) Nuga looks at the world she asks a different question: could we make this even better?
Dr. Nuga is now a primary care physician at Pacific Medical Centers (PacMed) Canyon Park, but before she went to medical school she earned a PhD in Microbiology and conducted medical research.
One of my research areas was retroviruses, which is the class of virus that HIV belongs to. I wanted to understand why patients with HIV cant stop taking the medications to treat it, even when theyve taken those medications for decades. Where is the virus hiding in the body?
Advances in medications mean patients with HIV can now expect to live an average lifespan, but that wasnt good enough for Dr. Nuga. She hopes her research into bone marrow stem cells will contribute to a cure.
Only two people in the world are confirmed to have been cured of HIV, and both of them received a stem cell transplant as part of their treatment, she says.
Coordinating your care
HIV treatment is not yet part of Dr. Nugas practice, but as a primary care physician she coordinates with specialists and ensures her patients receive comprehensive care for the best possible outcomes. Since people living with HIV can expect to live an average lifespan, they need to continue caring for other aspects of their health in addition to HIV care cancer screenings, mental health, and other ongoing primary care.
Think of Dr. Nuga as your health care quarterback: calling plays and adapting strategies on the fly to develop a treatment plan that works for you. That may mean adjusting doses to your weight and age, but it could also mean adjusting referrals to accommodate your culture, social class or even access to transportation.
I want to address the barriers to care and deliver healthcare to everyone that needs it, regardless of their status. The resources at PacMed are a big help I can coordinate with care managers and community health liaisons to make sure nobody falls through the cracks, she says.
Dr. Nuga loves taking care of patients of all ages, life stages and social situations, and she has a soft spot for children.
Theres a special privilege that comes with taking care of babies from the first day of life, she says, and she hopes to have more opportunities to practice pediatrics.
Another way Dr. Nuga hopes to improve healthcare? Wit better representation throughout the system so patients see themselves in health care professionals from patient care to management.
Im hoping to get involved with the Providence mentorship program, to help inspire the next generation. The number of physicians from some minority groups hasnt changed since 1978 its kind of astounding that over 40 years we havent been able to increase representation, she says. If we improve access to care we make the environment better for everyone.
Dr. Nugas pediatric and internal medicine practice is open to people of all ages, from newborns to geriatrics. Make an appointment with Dr. Nuga for you or your child by calling 425-412-7200 or booking online. Find Dr. Nuga at Pacific Medical Centers (PacMed) Canyon Park, 1909 214th St. SE, in Bothell.
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Her favorite part of research was the patients, so she switched to primary... - Bothell-Kenmore Reporter
Cell Harvesting Market 2020 Growth Analysis, Share, and consumption by Regional data, Investigation and Growth, Demand by Regions, Types and Analysis…
By daniellenierenberg
Cell harvesting usuallyfor use incanceror other treatment. Usually the cells are removed from the patients own bone marrow. Stem cells can be harvested from the blood or bone marrow. Umbilical cords have been saved as a future source of stem cells for the baby..cagr1 with growth trends, various stakeholders like investors, CEOs, traders, suppliers, Research & media, Global Manager, Director, President, SWOT analysis i.e. Strength, Weakness, Opportunities and Threat to the organization and others.
Get a sample copy of the Cell Harvesting market report 2020
Competitive Landscapeand Cell HarvestingMarket Share AnalysisCell Harvesting competitive landscape provides details by vendors, including company overview, company total revenue (financials), market potential, global presence, Cell Harvestingsales and revenue generated, market share, price, production sites and facilities, SWOT analysis, product launch. For the period 2015-2020, this study provides the Cell Harvestingsales, revenue and market share for each player covered in this report.
Cell HarvestingMarket competition by Top Countries manufacturers/ Key player Data Profiled:
PerkinElmer (US),,Brandel (US),,TOMTEC (US),,Cox Scientific (UK),,Connectorate (Switzerland),,Scinomix (US),,ADSTEC (Japan),,Sartorius,,Terumo Corporation,,
And More
Get a Sample PDF of report @https://www.360marketupdates.com/enquiry/request-sample/13061329
Market segmentation
Cell Harvesting Market is split by Type and by Application. For the period 2015-2025, the growth among segments provide accurate calculations and forecasts for sales by Type and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.
Cell Harvesting Market Segment by Type covers:
Cell Harvesting Market Segment by Applications can be divided into:
Scope of theCell Harvesting MarketReport:
Fill the Pre-Order Enquiry form for the report@https://www.360marketupdates.com/enquiry/pre-order-enquiry/13061329
Regional analysis covers:
The report provides an in-depth knowledge of the Global Cell Harvesting market scenario:
Other Major Topics Covered in Cell Harvesting market research report are as follows:
And another component .
The next part also sheds light on the gap between supply and consumption. Apart from the mentioned information,growth rateof Cell Harvesting market in 2025is also explained.Additionally, type wise and application wise consumptiontables andfiguresof Cell Harvesting marketare also given.
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Cell Harvesting Market 2020 Growth Analysis, Share, and consumption by Regional data, Investigation and Growth, Demand by Regions, Types and Analysis...
BioCardia Reports Third Quarter 2020 Financial Results and Business Highlights – GlobeNewswire
By daniellenierenberg
SAN CARLOS, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- BioCardia, Inc.[NASDAQ: BCDA], a leader in the development of autologous and allogenic cell therapies, today reported financial results and business highlights for the third quarter of 2020 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2020 with the Securities and Exchange Commission on November 10, 2020.
The Company is advancing its autologous and allogenic bone marrow-derived cell therapies for three cardiovascular indications and one respiratory indication.
Third Quarter 2020 Business Highlights:
Autologous Cell Therapies
Allogenic Cell Therapies
Corporate Developments
We are reaching critical milestones in our cardiovascular and respiratory cell therapy development programs at a time when patients are increasingly presenting with heart damage due to COVID-19, said BioCardia CEO Peter Altman, PhD. We believe that the clinical data supports patient benefit through paracrine mechanisms, which differs from those attempting to transform cells into new heart cells, and believe that the approach has tremendous promise to help patients suffering from severe heart and respiratory diseases.
Third Quarter 2020 Financial Results:
Anticipated Upcoming Milestones in Q4 2020:
About BioCardiaBioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular and respiratory disease. CardiAMP autologous and Neurokinin-1 Receptor Positive allogenic cell therapies are the Companys biotherapeutic platforms in clinical development. The Company's products include the Helix Biotherapeutic Delivery System and its steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix system and clinical support for their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. For more information, visit http://www.BioCardia.com.
Forward Looking StatementsThis press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the enrollment of our clinical trials, the availability of data from our clinical trials, filings with the FDA, FDA product clearances, the efficacy and safety of our products and therapies, anticipated milestones, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardias business and product development plans and overall market conditions.We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control.Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent development of our therapeutic candidates.These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.
We may use terms such as believes, estimates, anticipates, expects, plans, intends, may, could, might, will, should, approximately or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate.Additional factors that could materially affect actual results can be found in our documents filed with the SEC, including our recent filings on Form 8-K, Form 10-K and Form 10-Q, particularly any statements under the caption entitled Risk Factors Therein. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Media Contact:Michelle McAdam, Chronic Communications, Inc.michelle@chronic-comm.com(310) 902-1274
Investor Contact:David McClung, Chief Financial OfficerInvestors@BioCardia.com(650) 226-0120
BIOCARDIA, INC.Condensed Statements of Operations(Unaudited In thousands, except share and per share amounts)
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BioCardia Reports Third Quarter 2020 Financial Results and Business Highlights - GlobeNewswire
Jehovahs Witness, 15, shouldnt be allowed to die says High Court judge after teen refuses lifesaving blood t – The Sun
By daniellenierenberg
A TEENAGE Jehovah's Witness was ordered to undergo a lifesaving blood transfusion after a concerned judge quashed her religious objection.
Doctors received the go-ahead to urgently give the 15-year-old blood when she was just hours from death.
3
The teen suffers from sickle cell, an inherited condition that affects red blood cells.
It puts her at greater risk of suffering a debilitating stroke - or dying.
At the High Court on Tuesday, November 10, Sir James Munby said the girl's life was in imminent danger, so he had rushed to make his decision, reports the Daily Mail.
He explained: "The blood transfusion is imperatively needed and within a timescale measured in hours, and not days.
"At one point, her doctor lamented that four hours had gone by because of the judicial proceedings."
Sir James described the patient as "wise beyond her years".
The unnamed teen has recently been baptised as a Jehovah's Witness, and has "profound religious beliefs".
Although Jehovah's Witnesses do not accept blood transfusions or blood products, based on biblical readings, he warned failure to help her presented a "very real risk" of "serious harm to her future health and welfare".
He acknowledged that the girl may end up refusing blood transfusions when older, and has more say on her medical treatment.
3
Sir James suggested that legal precedents dating back three decades needed to be re-examined for cases like this.
These previous decisions state that kids shouldn't have a say in whether or not they accept medical treatment.
In just three years time, when she reaches the age of 18, the girl will be legally able to reject such lifesaving help.
However, Sir James recommended the High Court to look at whether she should have more say on treatments - including blood transfusions - before she turns 18.
A 1970s ruling says Jehovah's Witnesses' beliefs must be given the same respect as those of other religions when it comes to kids' rights to reject treatment.
Appeal Court decisions in the 1990s stress that courts must decide what is in the best interests of under-16s, the Mail writes.
Teens aged 16 and 17 are allowed to have a say in their treatment - but this can be overruled in exceptional cases.
What is Sickle Cell?
Sickle cell disease (SCD) is a serious and lifelong health condition.
Sickle cell disease is the name for a group of inherited health conditions that affect the red blood cells.
The most serious type is called sickle cell anaemia.
People with sickle cell disease produce unusually shaped red blood cells.
These can cause problems because they do not live as long as healthy blood cells and can block blood vessels.
People with SCD start to have signs of the disease during the first year of life, usually around five months of age.
Symptoms and complications of SCD are different for each person and can range from mild to severe.
The only cure for SCD is bone marrow or stem cell transplant.
Sickle cell disease varies between individuals from mild to serious, but most people with it lead happy and normal lives.
But the illness can be serious enough to have a significant effect on a person's life, says the NHS.
It can lead to health problems like strokes, serious infections and lung problems, which can occasionally be fatal.
3
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Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia | Small Molecules | News Channels – PipelineReview.com
By daniellenierenberg
DetailsCategory: Small MoleculesPublished on Monday, 09 November 2020 08:56Hits: 725
Calquence demonstrated superior progression-free survival and favourable tolerability in both previously untreated and relapsed or refractory patients
LONDON, UK I November 9, 2020 I AstraZenecas Calquence (acalabrutinib), a next-generation selective Brutons tyrosine kinase (BTK) inhibitor, has been approved in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.
The approval by the European Commission was based on positive results from two Phase III clinical trials, ELEVATE-TN in patients with previously untreated CLL and ASCEND in patients with relapsed or refractory CLL.1,2 This follows a recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency in July 2020.
Paolo Ghia, MD, Director, Strategic Research Program on CLL, Universit Vita-Salute San Raffaele in Milan, and investigator of the ASCEND Phase III trial, said: One of our biggest hurdles in treating chronic lymphocytic leukaemia is finding tolerable treatment options that manage the disease long term, which typically impacts older patients with comorbidities. Todays news marks great progress for patients in Europe, as the Phase III clinical trials for Calquence showed a significant improvement in comparison with current standard treatments.
Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: This approval represents a key development for patients in Europe who until now have had limited chemotherapy-free treatment options. As our first European approval in blood cancers, Calquence provides a new tolerable treatment option with uncompromised efficacy and the potential to positively impact the quality of life for thousands of patients living with chronic lymphocytic leukaemia.
In the ELEVATE-TN Phase III trial, Calquence combined with obinutuzumab and as monotherapy reduced the risk of disease progression or death by 90% and 80%, respectively, compared with standard chemo-immunotherapy treatment chlorambucil plus obinutuzumab, in patients with previously untreated CLL.1 In the ASCEND Phase III trial, 88% of patients with relapsed or refractory CLL taking Calquence remained alive and free from disease progression after 12 months compared with 68% of patients on rituximab combined with idelalisib or bendamustine.2 Data from the interim results of the trials were published in The Lancet and Journal of Clinical Oncology, respectively.
Calquence is approved for the treatment of CLL and small lymphocytic lymphoma in the US and is approved for CLL in several other countries worldwide. Calquence is also approved for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy in the US and several other countries. Calquence is not currently approved for the treatment of MCL in Europe.
As part of a broad development programme, Calquence is being assessed in more than 20 AstraZeneca-sponsored clinical trials for the treatment of patients with B-cell malignancies including CLL, MCL, diffuse large B-cell lymphoma (DLBCL), Waldenstrms macroglobulinaemia (WM), follicular lymphoma (FL), and other haematologic malignancies.
Chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in adults, with an estimated 105,000 new cases globally in 2016, and the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease.3,4,5,6 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells, and platelets. This could result in anaemia, infection, and bleeding.4 B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.
ELEVATE-TN
ELEVATE-TN (ACE-CL-007) was a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy of Calquence in combination with obinutuzumab, a CD20 monoclonal antibody, or Calquence alone versus chlorambucil, a chemotherapy, in combination with obinutuzumab in previously untreated patients with CLL. Patients 65 years of age or older, or between 18 and 65 years of age with a total Cumulative Illness Rating Scale >6 or creatinine clearance of 30 to 69mL/min, were enrolled. In the trial, 535 patients were randomised (1:1:1) into three arms. Patients in the first arm received chlorambucil in combination with obinutuzumab. Patients in the second arm received Calquence (100mg approximately every 12 hours until disease progression or unacceptable toxicity) in combination with obinutuzumab. Patients in the third arm received Calquence monotherapy (100mg approximately every 12 hours until disease progression or unacceptable toxicity).1
The primary endpoint was progression-free survival (PFS) in the Calquence and obinutuzumab arm compared to the chlorambucil and obinutuzumab arm, assessed by an independent review committee (IRC), and a key secondary endpoint was IRC-assessed PFS in the Calquence monotherapy arm compared to the chlorambucil and obinutuzumab arm. Other secondary endpoints included objective response rate, time to next treatment and overall survival (OS).1
ASCEND
ASCEND (ACE-CL-309) was a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of Calquence in patients with relapsed or refractory CLL. In the trial, 310 patients were randomised (1:1) into two arms. Patients in the first arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity). Patients in the second arm received investigators choice of either rituximab, a CD20 monoclonal antibody, in combination with idelalisib, a PI3K inhibitor, or rituximab in combination with bendamustine, a chemotherapy.2
The primary endpoint was PFS assessed by an IRC, and key secondary endpoints included physician-assessed PFS, IRC- and physician-assessed overall response rate and duration of response, as well as OS, patient-reported outcomes and time to next treatment.2
Calquence
Calquence (acalabrutinib) is a next-generation, selective inhibitor of BTK. Calquence binds covalently to BTK, thereby inhibiting its activity.7,8 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.7
As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in more than 20 company-sponsored clinical trials. Calquence is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, DLBCL, WM, FL, and other haematologic malignancies.
AstraZeneca in haematology
Leveraging its strength in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus. The Companys haematology franchise includes two medicines approved by the US Food and Drug Administration and a robust global development programme for a broad portfolio of potential blood cancer treatments. Acerta Pharma serves as AstraZenecas haematology research and development arm. AstraZeneca partners with like-minded science-led companies to advance the discovery and development of therapies to address unmet need.
AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio ofnew medicines that has the potential to transform patients lives and the Companys future. With seven new medicines launched between 2014 and 2020, and a broad pipelineof small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and haematology.
By harnessing the power of six scientific platforms - Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies - and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visitastrazeneca.comand follow the Company on Twitter@AstraZeneca.
References
1. Sharman JP, et al. ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL). Blood. 2019; 134 (Supplement_1): 31. doi:10.1182/blood-2019-128404.
2. Ghia P, et al. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia [published online ahead of print, 2020 May 27]. J Clin Oncol. 2020; JCO1903355. doi:10.1200/JCO.19.03355.
3. American Cancer Society. What is Chronic Lymphocytic Leukemia? Available at https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html. Accessed August 2020.
4. National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)Patient Version. Available at https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq. Accessed August 2020.
5. Global Burden of Disease Cancer Collaboration. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016. JAMA Oncol. 2018;4(11):1553-1568.
6. Jain N, et al. Prevalence and Economic Burden of Chronic Lymphocytic Leukemia (CLL) in the Era of Oral Targeted Therapies. Blood. 2015;126:871.
7. Calquence (acalabrutinib) [prescribing information]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019.
8. Wu J, Zhang M & Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol. 2016;9(21).
SOURCE: AstraZeneca
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Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia | Small Molecules | News Channels - PipelineReview.com
Exploring Genetic Variation and COVID-19 Clinical Variability – Technology Networks
By daniellenierenberg
One of the biggest challenges that scientists and healthcare professionals are facing during the COVID-19 pandemic is the high rate of clinical variability. Whilst some patients present as asymptomatic, others are developing more severe symptoms such as pneumonia, and some cases are ultimately proving fatal. Why?The answer remains elusive; however, extensive research is exploring the possible contribution our genetics may be having. Genetic variation differences in the DNA sequences that make up our genome can impact our response to infectious diseases.
GoodCell uniquely measures and monitors inherited and acquired genetic variations in stem cells and other nucleated cells in our blood over time. Technology Networks recently spoke with Dr Salvatore Viscomi, chief medical officer at GoodCell, and attending physical at Baystate Health, to explore factors that might influence COVID-19 risk, and to discuss how the company is working to identify at-risk individuals through genetic variation analysis.
Molly Campbell (MC): For our readers that may be unfamiliar, can you discuss why medicine is moving towards a personalized approach, and why this is important considering genetic variation?Salvatore Viscomi (SV): Healthcare has traditionally taken the approach of one size fits all in defining individual risk for a disease and prescribing therapy for it. Understanding the differences between individuals on a molecular level optimizes assessment of an individuals susceptibility to a certain disease and predicting response to pharmacological therapy. Genomics plays the most important role in the emergence of personalized therapy. Identifying the inherited and acquired genetic variation will direct personalized screening and prevention plans and inform bespoke medical therapies.
MC: We know that there is high clinical variability across COVID-19 patients. How might genetic variation be contributing here, and what published evidence exists to support this?SV: Understanding immune response is critical to identifying individuals at high risk of severe morbidity and mortality. Emerging research suggests that accumulated genetic variation in our blood cells may be associated with a dysfunctional inflammatory response to COVID-19 leading to its pulmonary, cardiac and coagulopathic complications.
In a recent study published by JAMA Cardiology, researchers demonstrated an association between the presence of accumulated genetic change in our blood cells and a pro-inflammatory immune response that resembles the exaggerated cytokine release syndrome (CRS) manifested in COVID-19-positive patients. Direct evidence has emerged more recently; a study published in Cancers examined patients hospitalized with COVID-19 and found a significantly higher prevalence of accumulated genetic variation in all age groups compared to age-matched control groups.
MC: What impact might genetic variation in COVID-19 patients have on efforts to develop therapeutics or preventives, such as vaccines?SV: Identifying highly susceptible individuals through blood testing could have many applications. As an initial wave of vaccines move through Phase III trials and potentially come to market, we would have the data to determine prioritization of vaccinations when one is available. Business and government sectors need insight into risk factors that can inform inoculation strategies for societys most vulnerable, inform decisions around who should and should not be on the front lines, and give people more control when making personal decisions about how to mitigate individual risk. The broader field of genetics offers a window into the potential to correlate inherited and acquired gene mutations with immune response for the betterment of society, providing a more robust and accurate set of risk factors unique to every individual.
Furthermore, in high-risk individuals, targeting inflammation may be a clinical strategy to mitigate its clinical consequencesin COVID-19. For example, we may identify patients who are most responsive to pro-inflammatory inhibitors. Implementing measures intended to reduce subjects exposure to the infection or likelihood of contracting such infection through self-isolation, quarantine or social distancing may be advised.
MC: Can you explain the aims of GoodCell, and what the company does in terms of "banking blood for life"?SV: GoodCells mission is to extend and improve the quality of life through technology powered by our own cells. Blood is the author of our bodies, and can both cure as well as cause disease. Through our proprietary data aggregation and analytics technology platform, which aims to decode our blood cells and harness their insights to advance population and personal health, we empower individuals to identify, track and mitigate health risks. By getting ahead of their health risks, we enable the potential for a better life. In addition, through our personal biobanking service, long-term storage of your healthiest cells provides the opportunity for potential use in future therapeutics if you need them you are your best donor.
MC: Does GoodCell measure other "omics" parameters outside of genomics (DNA measurements and analysis), such as proteomics or metabolomics?SV: GoodCells platform leverages the power of blood to assess risk as such, we of course look at acquired and inherited genetic changes, but there are many more opportunities afforded by blood to understand and assess risk including routine blood chemistry tests, tests for biomarkers of disease, including emerging capabilities in liquid biopsy for earlier detection of solid tumor cancers. Ultimately, we are always looking to incorporate novel health and data insights into our product platform to better inform both an individuals health, as well as population-based health. Transcriptomics, epigenomics and metabolomics are but a few of the opportunities we are evaluating.
MC: What work is GoodCell currently conducting in the COVID-19 space?SV: GoodCell is currently engaged in a research collaboration with the New York Blood Center to evaluate how specific acquired and inherited genetic variation contribute to COVID-19 severity and recovery. We are analyzing genetic variation in asymptomatic/mildly symptomatic patients compared to hospitalized/ICU patients. GoodCell will evaluate the genetic variation in the collected samples using our proprietary assay platform to identify and validate their association with COVID-19 morbidity and mortality.
Salvatore Viscomi was speaking to Molly Campbell, Science Writer, Technology Networks.
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Exploring Genetic Variation and COVID-19 Clinical Variability - Technology Networks
KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall…
By daniellenierenberg
KENILWORTH, N.J., & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Nov 10, 2020--
Merck (NYSE: MRK):
KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Statistically Significant Improvement inProgression-Free Survival (PFS), Overall Survival (OS) and Objective Response Rate (ORR) Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma
LENVIMA Plus Everolimus Also Showed Statistically Significant Improvement in PFS and ORR Endpoints Versus Sunitinib
Results of Investigational Phase 3 KEYNOTE-581/CLEAR Trial (Study 307) to be Presented at Upcoming Medical Meeting
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced new investigational data demonstrating positive top-line results from the pivotal Phase 3 KEYNOTE-581/CLEAR trial (Study 307). In the trial, the combinations of KEYTRUDA, Mercks anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, and LENVIMA plus everolimus were evaluated versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). KEYTRUDA plus LENVIMA met the trials primary endpoint of progression-free survival (PFS) and its key secondary endpoints of overall survival (OS) and objective response rate (ORR), demonstrating a statistically significant and clinically meaningful improvement in PFS, OS and ORR versus sunitinib in the intention-to-treat (ITT) study population. LENVIMA plus everolimus also met the trials primary endpoint of PFS and a key secondary endpoint of ORR, demonstrating a statistically significant and clinically meaningful improvement in PFS and ORR versus sunitinib in the ITT study population. The ITT population included patients across all Memorial Sloan Kettering Cancer Center (MSKCC) risk groups (favorable, intermediate and poor). The safety profiles of both KEYTRUDA plus LENVIMA and LENVIMA plus everolimus were consistent with previously reported studies. Merck and Eisai will discuss these data with regulatory authorities worldwide, with the intent to submit marketing authorization applications based on these results, which will be presented at an upcoming medical meeting.
The results for KEYTRUDA plus LENVIMA versus sunitinib, which showed a statistically significant improvement in progression-free survival, overall survival and objective response rate, build on the growing scientific evidence that supports the investigation of KEYTRUDA-based combinations for the first-line treatment of advanced renal cell carcinoma, said Dr. Gregory Lubiniecki, Associate Vice President, Oncology Clinical Research, Merck Research Laboratories. Merck and Eisai are committed to working together to continue to explore the potential of the KEYTRUDA plus LENVIMA combination, particularly in areas of great unmet need such as renal cell carcinoma.
The results from KEYNOTE-581/CLEAR (Study 307) support the potential use of KEYTRUDA plus LENVIMA for the first-line treatment of advanced RCC. These data also support the potential first-line use of LENVIMA plus everolimus, which is already approved in advanced RCC following prior antiangiogenic therapy, said Dr. Takashi Owa, Vice President, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. These findings energize our efforts as we continue to advance our understanding and address the unmet needs of patients with difficult-to-treat cancers.
Merck and Eisai are continuing to study the KEYTRUDA plus LENVIMA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program across 19 trials in 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, RCC, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer).
About KEYNOTE-581/CLEAR (Study 307)
KEYNOTE-581/CLEAR (Study 307) is a multi-center, randomized, open-label, Phase 3 trial (ClinicalTrials.gov, NCT02811861 ) evaluating LENVIMA in combination with KEYTRUDA or in combination with everolimus versus sunitinib for the first-line treatment of patients with advanced RCC. The primary endpoint is PFS by independent review per RECIST v1.1 criteria. Key secondary endpoints include OS, ORR and safety. The study enrolled approximately 1,050 patients who were randomized to one of three treatment arms to receive:
About Renal Cell Carcinoma (RCC)
Worldwide, it is estimated there were more than 403,000 new cases of kidney cancer diagnosed and more than 175,000 deaths from the disease in 2018. In the U.S. alone, it is estimated there will be nearly 74,000 new cases of kidney cancer diagnosed and almost 15,000 deaths from the disease in 2020. Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancers are RCCs. Renal cell carcinoma is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with RCC will have metastatic disease at diagnosis, and as many as 40% will develop metastases after primary surgical treatment for localized RCC. Survival is highly dependent on the stage at diagnosis, and with a five-year survival rate of 12% for metastatic disease, the prognosis for these patients is poor.
About KEYTRUDA (pembrolizumab) Injection, 100 mg
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 1,200 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 patient's 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 1 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 patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
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.
KEYTRUDA is indicated for the treatment of 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 are ineligible for or have elected not to undergo cystectomy.
Microsatellite Instability-High or Mismatch Repair Deficient 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.
Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer
KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
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).
Endometrial Carcinoma
KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. 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 trial.
Tumor Mutational Burden-High
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 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 TMB-H central nervous system cancers have not been established.
Cutaneous Squamous Cell Carcinoma
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Selected Important Safety Information for KEYTRUDA (pembrolizumab)
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 adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). 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 adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or 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.
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KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall...
Global Progenitor Cell Product Professional Survey 2020 by Manufacturers, Regions, Types and Applications, Forecast to 2026 – Zenit News
By daniellenierenberg
The report on the Progenitor Cell Product Market offers elaborated knowledge on the Progenitor Cell Product market. parts like dominating firms, classification, size, business atmosphere, SWOT analysis, and most effectual trends within the business area unit comprised during this analysis study. In this report, the global Progenitor Cell Product market is valued at USD XX million in 2020and is expected to reach USD XX million by the end of 2026, growing at a CAGR of XX% between 2020and 2026. additionally to the current, the report sports charts, numbers, and tables that provide a transparent viewpoint of the Progenitor Cell Product market. The dominant firms NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, RD Systems, Lonza, ATCC, Irvine Scientific, CDI area unit to boot mentioned within the report.
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The latest knowledge has been conferred within the Global Progenitor Cell Product market study on the revenue numbers, product details, and sales of the foremost corporations. additionally, to the current, this data conjointly includes the breakdown of the revenue for the Progenitor Cell Product market additionally to claiming a forecast for a similar within the calculable timeframe. The strategic business techniques accepted by the noteworthy members of the Global Progenitor Cell Product market have conjointly been integrated during this report. Key weaknesses and strengths, additionally to claiming the hazards encountered by the most contenders within the Progenitor Cell Product market, are a fraction of this analysis study. The report conjointly categorizes the market into main product kind Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cellsEndothelial progenitor cellsOthers and the sub-segments Medical care, Hospital, Laboratory of the Progenitor Cell Product market are depicted in the report
NOTE:Our report highlights the major issues and risks that companies might come across due to the exceptionaloutbreak of COVID-19.
The Global Progenitor Cell Product market report includes a profound outline of the key sectors of the Progenitor Cell Product market. each quickly and slowly growing sectors of the Progenitor Cell Product market are examined via this study. Forecast, share of the market, and size of every s and sub-segment is getable within the study. The key energetic possibilities associated with the foremost quickly growing segments of the market also are a fracturing of this report. what is more, classification supported geographies also because the trends powering the leading regional markets and developing geographies is obtainable during this analysis study. the Global Progenitor Cell Product market report wraps regions that area unit in the main classified into North America, Europe, Asia Pacific, Latin America, and Mideast and Africa.
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The report on the & what is more offers a written account factsheet regarding the strategic mergers, acquirements, venture activities, and partnerships widespread within the Progenitor Cell Product market. outstanding suggestions by senior consultants on tactical defrayal in analysis and development may facilitate energetic entrants also as respectable firms for increased incursion within the developing segments of the Progenitor Cell Product market. Market players may accomplish a transparent perception of the most rivals within the Progenitor Cell Product market additionally to their future forecasts. The report conjointly analyses the market in terms of volume [k MT] and revenue [Million USD].
There are 15 Chapters to display the Global Progenitor Cell Product market
Chapter 1,Definition, Specifications and Classification of Progenitor Cell Product, Applications of Progenitor Cell Product, Market Segment by Regions;Chapter 2,Manufacturing Cost Structure, Raw Material, and Suppliers, Manufacturing Process, Industry Chain Structure;Chapter 3,Technical Data and Manufacturing Plants Analysis of Progenitor Cell Product, Capacity, and Commercial Production Date, Manufacturing Plants Distribution, R&D Status and Technology Source, Raw Materials Sources Analysis;Chapter 4,Overall Market Analysis, Capacity Analysis (Company Segment), Sales Analysis (Company Segment), Sales Price Analysis (Company Segment);Chapter 5 and 6,Regional Market Analysis that includes the United States, China, Europe, Japan, Korea & Taiwan, Progenitor Cell Product Segment Market Analysis (by Type);Chapter 7 and 8,The Progenitor Cell Product Segment Market Analysis (by Application) Major Manufacturers Analysis of Progenitor Cell Product ;Chapter 9,Market Trend Analysis, Regional Market Trend, Market Trend by Product Type Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cellsEndothelial progenitor cellsOthers, Market Trend by Application;Chapter 10,Regional Marketing Type Analysis, International Trade Type Analysis, Supply Chain Analysis;Chapter 11,The Consumers Analysis of Global Progenitor Cell Product ;Chapter 12,Progenitor Cell Product Research Findings and Conclusion, Appendix, methodology and data source;Chapter 13, 14, and 15,Progenitor Cell Product sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix, and data source.
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Global Progenitor Cell Product Professional Survey 2020 by Manufacturers, Regions, Types and Applications, Forecast to 2026 - Zenit News
Advancement: Know the Rapid Growth Factors of Biopreservation Market| Stay Up-To-Date With Emerging – PharmiWeb.com
By daniellenierenberg
Pune, Maharashtra,India, November 9 2020 (Wiredrelease) Origius Systems Private Limited :The increasing occurrence of chronic ailments and obesity all over the world is driving the global biopreservation market growth. The North America region is expected to lead the market growth in the projected period.
A latest report by Research Dive on the global biopreservation market reveals that the market is projected to hit $13,576.3 million by 2027, rising at a CAGR of 13.8% from 2020 to 2027. The report states the current outlook and future growth of the market. The research report is a perfect source of guidance for companies and individuals interested in investing in the market.
The report covers the following aspects:
A brief introduction of the market with its definition, advantages, and application areas. Inclusive insights on the market situation, dynamics, statistics, growth rate, revenues, market shares, and future predictions. Major market segments, drivers, limitations, and investment suitability. Current scenario of the global and regional market from the perspective of companies, countries, and end industries. Insights on foremost market players, current market trends & developments, SWOT Analysis, Porter Five Analysis, and winning business strategies.
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Factors Impacting the Market Growth:
According to the report, growing occurrence of chronic ailments like diabetes, cardiac, degenerative conditions affecting the joints, nerves, bones, and others as well as obesity all over the world are thrusting the demand for biopreservation techniques, which is fueling the growth of the market. Additionally, the increasing investments in R&D and development of advanced biopreservation products is expected to unlock rewarding opportunities for the market growth. However, greater costs involved in biopreservation processes, reliability concerns, and invention of low-priced processes are likely to detain the biopreservation market growth.
Segment Analysis:
The report segments the biopreservation market into type, biospecimen, application, end use, and region.
Based on biospecimen, the report divides the market into: Stem Cells Human Tissue Organs
Among these, the human tissue segment is expected to witness highest growth in the biopreservation market all through the projected period; mainly due to rising cases of chronic ailments, degenerative disorders, and obesity.
Based on application, the report classifies the market into: Therapeutic Research Clinical Trials
Among these, the therapeutic segment is projected to show noteworthy growth during the forecast period. This is mainly owing to the developments in treatment techniques, personalized drugs, regenerative drugs, increasing trend for cord blood banking, and increasing occurrence of chronic ailments worldwide.
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Regional Analysis:
The report states the scenario of the global biopreservation market across several regions including: Europe LAMEA North America Asia Pacific
Among these, the North America region is projected to grab the highest market share of the biopreservation market in the forecast period. This is attributed to the growing awareness about personalized drugs, rising R&D in regenerative medicines, increasing prevalence of obesity, and chronic ailments.
Market Players and Business Strategies:
The report cites some of the leading players in the global biopreservation market which includes: Avantor, Inc. Bio-Techne Exact Sciences Corporation Merck KGaA ThermoGenesis Corp. BioLifeSolutions Inc. BioCision Chart Industries Thermo Fisher Scientific Inc. Worthington Industries, Inc.
The report highlights some of the wining business strategies of the players such as mergers and acquisitions, ground-breaking advances, geographical expansions, new product inventions, and many more.Quick Download Top Companies Development Strategies Summary Report
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Advancement: Know the Rapid Growth Factors of Biopreservation Market| Stay Up-To-Date With Emerging - PharmiWeb.com
Mesenchymal Stem Cells Market to Witness Significant Rise in Revenue and Covid-19 Impact by 2026 | Celprogen Inc., Axol Bioscience Ltd., Stemedica…
By daniellenierenberg
Global Mesenchymal Stem Cells market report 2020 offers extremely oblique professional analysis and forecast from 2020 to 2026. The report also consists of market shares, size, profit revenue, and the Mesenchymal Stem Cells markets economic process. It also covers the strategic identification of major players within the market and analyzing their core competencies and methodology. The Mesenchymal Stem Cells market report analyzes information collected and integrated through recent analysis techniques and from trustful sources across varied industries.
A thorough evaluation of the restrains encompassed in the Mesenchymal Stem Cells report reveals the difference to drivers and contributes room for strategic planning. Features that overshadow the Mesenchymal Stem Cells market development are essential. They can be understood to devise different bends for getting hold of the profitable prospects present in the ever-growing market. Additionally, perceptions by market expert opinions have been taken to understand the Mesenchymal Stem Cells market better.
[Due to the pandemic, we have included a special section on the Impact of COVID 19 on the market which would mention How the Covid-19 is Affecting the Global Mesenchymal Stem Cells Market]
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Top Key Players of Mesenchymal Stem Cells Market:
(Celprogen Inc., Axol Bioscience Ltd., Stemedica Cell Technologies Inc., Cell Applications Inc., Stem cell technologies Inc., Cytori Therapeutics Inc., Cyagen Biosciences Inc., BrainStorm Cell Therapeutics.)
On the basis of Types, the Mesenchymal Stem Cells market:
Bone Marrow Umbilical Cord Blood Peripheral Blood Lung Tissue Synovial Tissues Amniotic Fluids Adipose Tissues
On the basis of Applications, the Mesenchymal Stem Cells market:
Injuries Drug Discovery Cardiovascular Infraction Others
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Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2016-2026) of the following regions are including,
The Research aims of the Mesenchymal Stem Cells Market report would be:
Major TOC points
1Mesenchymal Stem Cells Market Overview
1.1 Product Overview and Scope of Mesenchymal Stem Cells
1.2 Segment by Type
1.2.1 Global Sales Growth Rate Comparison by Type (2021-2026)
1.2.2 Type 1
1.2.3 Type 2
1.3 Segment by Application
1.3.1 Sales Comparison by Application: 2020 VS 2026
1.3.2 Application 1
1.3.3 Application 2
1.4 Global Market Size Estimates and Forecasts
1.4.1 Global Revenue 2016-2026
1.4.2 Global Sales 2016-2026
1.4.3 Mesenchymal Stem Cells Market Size by Region: 2020 Versus 2026
2 Global Mesenchymal Stem Cells Market Competition by Manufacturers
2.1 Global Sales Market Share by Manufacturers (2016-2020)
2.2 Global Revenue Share by Manufacturers (2016-2020)
2.3 Global Average Price by Manufacturers (2016-2020)
2.4 ManufacturersMesenchymal Stem Cells Manufacturing Sites, Area Served, Product Type
2.5 Market Competitive Situation and Trends
2.5.1 Mesenchymal Stem Cells Market Concentration Rate
2.5.2 Global Top 5 and Top 10 Players Market Share by Revenue
2.5.3 Market Share by Company Type (Tier 1, Tier 2, and Tier 3)
2.6 Manufacturers Mergers and Acquisitions, Expansion Plans
2.7 Primary Interviews with KeyMesenchymal Stem Cells Players (Opinion Leaders)
3 Mesenchymal Stem Cells Retrospective Market Scenario by Region
3.1 Global Mesenchymal Stem Cells Retrospective Market Scenario in Sales by Region: 2016-2020
3.2 Global Mesenchymal Stem Cells Retrospective Market Scenario in Revenue by Region: 2016-2020
3.3 North America Market Facts and Figures by Country
3.4 EuropeMesenchymal Stem Cells Facts and Figures by Country
3.5 Asia Pacific Market Facts and Figures by Region
3.6 Latin America Market Facts and Figures by Country
3.7 the Middle East and Africa Market Facts and Figures by Country
4 Global Mesenchymal Stem Cells Historic Market Analysis by Type
4.1 Global Sales Market Share by Type (2016-2020)
4.2 Global Revenue Market Share by Type (2016-2020)
4.3 Global Price Market Share by Type (2016-2020)
4.4 Global Market Share by Price Tier (2016-2020)
5 GlobalMesenchymal Stem Cells Historic Market Analysis by Application
5.1 Global Sales Market Share by Application (2016-2020)
5.2 Global Revenue Market Share by Application (2016-2020)
5.3 Global Price by Application (2016-2020)
..Countinued
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Mesenchymal Stem Cells Market to Witness Significant Rise in Revenue and Covid-19 Impact by 2026 | Celprogen Inc., Axol Bioscience Ltd., Stemedica...
Atreca to Present at Upcoming Virtual Investor Conferences
By Dr. Matthew Watson
SOUTH SAN FRANCISCO, Calif., Nov. 06, 2020 (GLOBE NEWSWIRE) -- Atreca, Inc. (Atreca) (NASDAQ: BCEL), a biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced that it will participate in the following upcoming virtual investor conferences:
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Atreca to Present at Upcoming Virtual Investor Conferences
Crinetics Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Corporate Update
By Dr. Matthew Watson
Reported positive topline results for the ACROBAT Edge and Evolve Phase 2 trials of oral paltusotine for the treatment of acromegaly
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Crinetics Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Corporate Update
Equillium Announces Positive Interim Data of Itolizumab in the First-line Treatment of Acute Graft-Versus-Host Disease
By Dr. Matthew Watson
100% overall response rate in dose cohort 3 and 80% overall response rate across all cohorts to date
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Equillium Announces Positive Interim Data of Itolizumab in the First-line Treatment of Acute Graft-Versus-Host Disease
Aeterna Zentaris Reports Third Quarter 2020 Financial Results and Provides Business Update
By Dr. Matthew Watson
– Pivotal Phase 3 safety and efficacy study AEZS-130-P02 (“Study P02”) expected to commence in Q1 2021
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Aeterna Zentaris Reports Third Quarter 2020 Financial Results and Provides Business Update
SCYNEXIS Reports Third Quarter 2020 Financial Results and Provides Company Update
By Dr. Matthew Watson
JERSEY CITY, N.J., Nov. 06, 2020 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to potentially overcome and prevent difficult-to-treat and drug-resistant infections, today reported financial results for the third quarter ended on September 30, 2020 and provided an update on recent clinical and corporate developments.
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SCYNEXIS Reports Third Quarter 2020 Financial Results and Provides Company Update
Kannalife, Inc. Rebrands as Neuropathix, Inc. and Unveils New Ticker Symbol
By Dr. Matthew Watson
DOYLESTOWN, Pa., Nov. 06, 2020 (GLOBE NEWSWIRE) -- Kannalife, Inc. (“Kannalife” or the “Company”) (OTCQB: KLFE), a biopharmaceutical and medchem company specializing in the research and development of potent novel monotherapeutics, announced today that the Company has changed its official name to Neuropathix, Inc. (“Neuropathix”) with a new ticker symbol (OTCQB: NPTX).
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Kannalife, Inc. Rebrands as Neuropathix, Inc. and Unveils New Ticker Symbol