Since its launch in 2018, skincare brand Augustinus Bader has been the It girl of the luxury beauty sphere, with a star-studded fan base thats impossible to ignore.

Founded by a world-renowned stem cell specialist and backed by decades of research, its admirers include the likes of Gigi Hadid, Kim Kardashian, Alexa Chung, Meghan Markle and Jennifer Aniston. Victoria Beckham was such a fan that she decided to collaborate with the brand to create skincare for her own line, VB Beauty.

If you dont trust the opinions of A-listers alone, you may also be interested to know that Augustinus Baders range was recently voted the greatest skincare of all time by a panel of 300 industry experts, beating the likes of La Mer and Estee Lauder to the title. The brand has also just launched an initiative that allows customers to choose a five per cent donation to a charity that matters to them, on every order, which only adds to its impressive credentials.

Ready to shop now? Browse the full Augustinus Bader range at Augustinusbader.com

So what is all the fuss about, we hear you ask? Well, it all boils down to some pretty impressive science. Professor Augustinus Bader, a German-born doctor, scientist and co-founder of the eponymous brand, has dedicated 30 years of his career to researching skin healing and tissue repair. This led to him creating a medical-grade hydrogel that treats the skin of burns victims. After envisioning how the success of this treatment could be applied to commercial skincare, Bader then incorporated the same technology into all of his products, in the form of his patented Trigger Factor Complex, known as TFC8. Still with us?

TFC8 is a cocktail of 40 different ingredients, including vitamins, amino acids and synthesised molecules found naturally in the body. Based on the idea that your body has an innate code for tissue repair, the complex essentially unlocks this code, forcing your skin into healing mode and tackling ageing, damage, scarring and dullness in the process. The brand claims that this technology visibly transforms the skin, and many consumers seem to agree.

But all of this technology comes at a rather eye-watering price, with the brands cult moisturiser costing 205. With this in mind, we spent a month exclusively testing Augustinus Baders products to see if they deliver on these transformative claims.

Were kicking off with the product that secured Augustinus Baders pivot to cult status. Youve almost certainly seen this moisturiser on many a bathroom shelfie its an instantly recognisable bottle that screams luxury straight off the bat. Like everything in the brands skincare line, the cream features the coveted TFC8 complex, and we were keen to see if it lives up to the hype. Regretfully for our bank accounts, we saw near-immediate results after using this cream. Its important to note that we paired the moisturiser with both the brands cleanser and the essence, which also feature TFC8, so our results may have been accelerated, but the cream was our favourite product.

The formula glides onto the skin with ease and absorbs quickly, but theres no luxury scent here (like us, you may prefer this, whether youre sensitive-skinned or more interested in the science). The added radiance is subtle, but the main thing we noticed was how plump our skin looks straight away. The brand describes this as a cushion-y bounce and we couldnt agree more its something weve yet to replicate in the same way from any other skincare product. Longer-term results after a month of use include reduced acne scarring and texture, a more even skin tone and generally healthier-looking skin. It really does feel as though our skin has been regenerated our make-up applied far better on a smoother base and we felt confident with clearer, happier skin.

Despite such technical ingredients, unlike other potent formulas, this is extremely gentle on the skin with no tingling or irritation. On the face of it, it feels like any other moisturiser, but its the results that speak for themselves. You can tell the brand is solely focused on science-backed results as opposed to all the bells and whistles, and were happy with that. The brand also offers a richer version of this moisturiser (205, Augustinusbader.com), and while we found it slightly too heavy for our oily skin, dry skin types will love it.

Housed in a weighty glass jar, the brands cleansing balm is a treat to use. Again, theres practically no scent here, but the buttery balm removes the day with ease. After applying the nourishing formula to dry skin, simply add water to emulsify and watch the balm turn into a milky consistency.

We love how much of a multi-tasker this cleanser is, removing even the heaviest of make-up effortlessly while leaving our skin feeling hydrated and plump. At 55, theres no doubt its an expensive cleanser, but youre paying for the long-term results from the brands regenerative TFC8 technology. Weve tried plenty of cheaper cleansing balms that do the job just as well, but you wont reap the skincare benefits that this one offers.

When paired with the brands other products, our skin was much brighter and clearer. Thankfully, its non-comedogenic too, meaning this is safe to use on acne-prone skin. Despite being great at removing make-up, we did find that we needed to apply quite a lot of the balm to remove it, so given the price, wed suggest using this as a second cleanse to make the most of it.

This toner-chemical-exfoliant-essence hybrid is really putting Augustinus Baders TFC8 complex to work, as the complex formula aims to resurface the skin while balancing it. Unlike other chemical exfoliants, it feels incredibly gentle on the skin with no irritation in sight.

The signature formula triggers the skins renewal processes, essentially forcing it to repair itself. Thanks to this, we noticed reduced acne scarring and redness, and far less texture after just a couple of weeks use. The essence also features gluconolacctone, a poly-hydroxy acid (PHA) that sloughs away dead skin cells, as well as the powerhouse ingredient salicylic acid to tackle congestion and blemishes.

Although using the essence with the brands moisturiser will give you optimum results, if youre stuck between the two, wed plump for this as a starting point for treating skincare concerns such as acne scarring and signs of ageing, as it showcases Baders TFC8 complex in the most potent way.

We cant give our final thoughts without addressing the elephant in the room here: the price. Its without a doubt on the luxury end of the spectrum, but the difficulty is that these products genuinely do work for us, delivering near instant results. There are definitely more affordable products out there that will help you to target acne scarring or dullness with similar success, but the real selling point here is how plump, smooth and seriously revitalised our skin looks after use.

Few skincare products deliver on every marketing promise, but Augustinus Baders do, and if you cant trust a world-leading stem cell scientist then who can you trust. Out of the whole range, wed recommend investing in the essence as a starting point, but if your budget stretches to both, the cream and the essence together make a powerful duo that wed definitely vouch for.

For the latest discounts on skincare and other beauty offers, try the links below:

IndyBest product reviews are unbiased, independent advice you can trust. On some occasions, we earn revenue if you click the links and buy the products, but we never allow this to bias our coverage. The reviews are compiled through a mix of expert opinion and real-world testing.

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T-cell leukemia is an uncommon form of cancer that causes a type of white blood cells known as T cells to grow uncontrollably in a persons bone marrow. Adult T-cell leukemia (ATL) is one form of the condition and results from a viral infection.

This information comes from the American Cancer Society.

Experts call the virus that causes ATL human T-cell leukemia virus type-1 (HTLV-1). This virus can also cause a type of lymphoma that begins in the immune system rather than the bone marrow. Doctors refer to the two conditions collectively as adult T-cell leukemia/lymphoma (ATLL).

This article looks at the types, symptoms, and causes of ATL. It also considers the treatment options and survival rates for those with the condition.

T-cell leukemia is a relatively rare form of cancer. Like other types of leukemia, it affects blood-forming cells in the bone marrow. These are cells that will go on to become blood cells but that are still in their early, or immature, form.

In addition to plasma, blood consists of red blood cells, white blood cells, and platelets. These cells go through several stages of development before becoming mature.

T-cell leukemia causes an abnormality in a specific type of immature white blood cells, known as T lymphocytes or T cells. T cells protect the body from infection. If these cells become cancerous, they divide and grow uncontrollably.

ATL is a type of T-cell leukemia caused by HTLV-1. The condition is rare in the United States, but it is more common in Japan, parts of Africa, South America, the Middle East, and the Caribbean.

Most people who contract HTLV-1 do not go on to develop any serious disease. HTLV-1 affects around 10 million people globally, but only 25% of them develop symptomatic ATLL.

There are four subtypes of ATLL:

Learn about the differences between leukemia and lymphoma here.

Symptoms of ATL can vary depending on the subtype a person has. People with the smoldering subtype may not have noticeable symptoms or may only develop a few skin lesions.

People with more aggressive forms of ATL may experience:

Hypercalcemia can be serious. It causes symptoms such as:

Children who develop ATLL often experience the acute or lymphomatous subtypes. Many develop an enlarged thymus, an organ that resides in front of the trachea, or windpipe. This can cause breathing problems.

To diagnose ATLL, a doctor will need to take samples of blood, bone marrow, or tissue. This may involve:

A healthcare professional can take blood from a vein in the arm, whereas bone or bone marrow usually comes from a hip bone.

A specialist will then examine the samples for signs of ATLL using various methods. They may use a microscope to examine them closely, or machines that test the samples proteins and DNA.

It is possible for ATL to go into remission. This means doctors cannot detect ATL in the body, and a person has no symptoms. Remission can be permanent or temporary.

However, ATL is often aggressive. The acute, lymphoma, and unfavorable chronic subtypes are more difficult to treat, while the favorable chronic and smoldering subtypes have a better prognosis.

For slow-growing forms of ATL, doctors may adopt a watch and wait approach to see whether the condition progresses. If the symptoms are mild and do not progress, a person may not need treatment or may not require it for some time.

Around 25% of cases of chronic or smoldering ATLL ultimately progress to the acute form. Anyone with acute ATLL typically undergoes treatment.

First-line treatment for ATL is antiviral therapy. Those with the lymphoma subtype seem to respond better to chemotherapy. Depending on the circumstances, a doctor may recommend one or both approaches.

Some individuals may also receive a stem cell transplantation from a donor, although this combined treatment is still under evaluation for its effectiveness.

Clinical trials are also testing the potential of immunomodulating drugs for ATL treatment.

ATL has a short overall survival rate, even with prompt treatment. This is because ATL is resistant to chemotherapy.

Data from 20002009 show that ATL patients who underwent intensive chemotherapy followed by stem cell transplantation had average survival times of:

Anyone who has completed treatment for ATLL will receive continuous health monitoring as part of their follow-up care. As the time spent in remission increases, these appointments become less frequent.

ATL occurs due to an infection with HTLV-1, a virus that belongs to the same class of viruses as HIV.

Similarly to HIV, HTLV-1 spreads through contact with bodily fluids. It can transmit through:

There is no cure or vaccine for HTLV-1. There is also no consistent method of screening for HTLV-1 worldwide and no way for doctors to predict who will go on to develop ATL. For this reason, preventing its spread is vital for preventing ATL.

However, because most people with HTLV-1 experience no symptoms, this can be challenging. Few studies have looked at the best ways of preventing HTLV-1 transmission.

Approaches that may help include:

Individuals should seek guidance from a doctor if they have any concerning symptoms, such as new rashes, skin lesions, or persistent fatigue.

They should also contact a doctor if they have come into contact with HTLV-1 at any point.

Where possible, schedule regular doctor visits. These give doctors an opportunity to perform physical examinations and obtain blood tests, as necessary. These may pick up on early signs of illness.

Some people with the slow-growing subtypes of T-cell leukemia have no symptoms. For these individuals, it is essential to visit a doctor as soon as any symptoms appear, because this could be a sign of the disease progressing.

ATL is a type of leukemia that affects the bodys T cells, which play a crucial role in the immune system. An HTLV-1 infection causes ATL.

ATL is often aggressive and difficult to treat. Those with a slow-growing subtype, such as smoldering ATL, usually have a better prognosis. The treatment may involve chemotherapy, antiviral drugs, or stem cell transplantation.

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The Stem Cell Therapy Market report provides a quick description about market status, size, companies share, growth, opportunities and upcoming trends. This report includes the corporate profile, values that the challenges and drivers & restraints that have a serious impact on the industry analysis. The information within the report that help form the longer term projections during the forecast year. The up so far analysis to assists in understanding of the changing competitive analysis. Additionally, the market strategies including moderate growth during the years.

The research on Stem Cell Therapy market scenario which will affect the overview the forecast period, including as opportunities, prime challenges, and current/future trends. To supply an in-depth analysis of all Stem Cell Therapy regions included within the report into sections to supply a comprehensive competitive analysis.

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Some of the leading manufacturers and suppliers of the Stem Cell Therapy market are Magellan, Medipost Co., Ltd, Osiris Therapeutics, Inc., Kolon TissueGene, Inc., JCR Pharmaceuticals Co., Ltd., Anterogen Co. Ltd., Pharmicell Co., Inc., and Stemedica Cell Technologies, Inc.

Stem cells are divided into two major classes; pluripotent and multipotent. Pluripotent stem cells are replicating cells, which are derived from the embryo or fetal tissues. The pluripotent stem cells facilitate the development of cells and tissues in three primary germ layers such as mesoderm, ectoderm, and endoderm.

Market Dynamics

Increasing expansion of facilities by market players for stem cell therapies is expected to propel growth of the stem cell therapy market over the forecast period. For instance, in January 2018, the University of Florida, U.S. launched the Center for Regenerative Medicine that is focused on development of stem cell therapies for the treatment of damaged tissue and organ. The Centre for Regenerative Medicines is divided into two segments such as focus groups and shared services. Focus groups such as research and development activities for stem cell therapies; and the shared services segment offers technical resources related to stem cell therapies.

Furthermore, rising collaboration activities by key players are expected to drive growth of the global stem cell therapy market. For instance, in May 2018, Procella Therapeutics and Smartwise, a medtech company entered into a collaboration with AstraZeneca Pharmaceuticals. Under this collaboration, AstraZeneca utilized Procella Therapeutics stem cell technology for the development of stem cell therapies in cardiovascular diseases. Moreover, in April, 2019, CelluGen Biotech and FamiCord Group collaborated to develop new stem cell-based drugs and advanced medical therapies (ATMP)

What Stem Cell Therapy Market Research Report Covers?

This report covers definition, development, market status, geographical analysis of Stem Cell Therapy market.

Competitor analysis including all the key parameters of Stem Cell Therapy market

Market estimates for at least 7 years

Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and proposals)

Strategic proposals in key business portions dependent available estimations

Company profiling with point by point systems, financials, and ongoing improvements

Mapping of the most recent innovative headways and Supply chain patterns

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Increasing application of stem cells for the treatment of patients with blood-related cancers, spinal cord injury and other diseases are the leading factors that are expected to drive growth of stem cell therapy market over the forecast period. According to the National Spinal Cord Injury Statistical Center, 2016, the annual incidence of spinal cord injury (SCI) is approximately 54 cases per million population in the U.S. or approximately 17,000 new SCI cases each year.

Moreover, according to the Leukemia and Lymphoma Society, 2017, around 172,910 people in the U.S. were diagnosed with leukemia, lymphoma or myeloma in 2017, thus leading to increasing adoption of stem cells for its efficient treatment. Increasing product launches by key players such as medium for developing embryonic stem cells is expected to propel the market growth over the forecast period.

For instance, in January 2019, STEMCELL Technologies launched mTeSR Plus, a feeder-free human pluripotent stem cell (hPSC) maintenance medium for avoiding conditions associated with DNA damage, genomic instability, and growth arrest in hPSCs. With the launch of mTeSR, the company has expanded its portfolio of mediums for maintenance of human embryonic stem (ES) cells and induced pluripotent stem (iPS) cells. Increasing research and development of induced pluripotent stem cells coupled with clinical trials is expected to boost growth of the stem cell therapy market over the forecast period.

For instance, in April 2019, Fate Therapeutics in collaboration with UC San Diego researchers launched Off-the-shelf immunotherapy (FT500) developed from human induced pluripotent stem cells. The therapy is currently undergoing clinical trials for the treatment of advanced solid tumors.

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Main points in Stem Cell Therapy Market Report Table of Content

Chapter 1 Industry Overview

1.1 Definition

1.2 Assumptions

1.3 Research Scope

1.4 Market Analysis by Regions

1.5 Global Stem Cell Therapy Market Size Analysis from 2021 to 2027

11.6 COVID-19 Outbreak: Stem Cell Therapy Industry Impact

Chapter 2 Global Stem Cell Therapy Competition by Types, Applications, and Top Regions and Countries

2.1 Global Stem Cell Therapy (Volume and Value) by Type

2.3 Global Stem Cell Therapy (Volume and Value) by Regions

Chapter 3 Production Market Analysis

3.1 Global Production Market Analysis

3.2 Regional Production Market Analysis

Chapter 4 Global Stem Cell Therapy Sales, Consumption, Export, Import by Regions (2016-2021)

Chapter 5 North America Stem Cell Therapy Market Analysis

Chapter 6 East Asia Stem Cell Therapy Market Analysis

Chapter 7 Europe Stem Cell Therapy Market Analysis

Chapter 8 South Asia Stem Cell Therapy Market Analysis

Chapter 9 Southeast Asia Stem Cell Therapy Market Analysis

Chapter 10 Middle East Stem Cell Therapy Market Analysis

Chapter 11 Africa Stem Cell Therapy Market Analysis

Chapter 12 Oceania Stem Cell Therapy Market Analysis

Chapter 13 South America Stem Cell Therapy Market Analysis

Chapter 14 Company Profiles and Key Figures in Stem Cell Therapy Business

Chapter 15 Global Stem Cell Therapy Market Forecast (2021-2027)

Chapter 16 Conclusions

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Stem Cell Therapy Market worth $40.3 billion by 2027 Exclusive Report by CoherentMarketInsights - PharmiWeb.com

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SAN FRANCISCO, Aug. 12, 2021 /PRNewswire/ --The global regenerative medicine marketsize is expectedto reach USD 57.08 billion by 2027, growing at a CAGR of 11.27% over the forecast period, according to a new report by Grand View Research, Inc. Recent advancements in biological therapies have resulted in a gradual shift in preference toward personalized medicinal strategies over the conventional treatment approach. This has resulted in rising R&D activities in the regenerative medicine arena for the development of novel regenerative therapies.

Key Insights & Findings:

Read 273 page research report, "Regenerative Medicine Market Size, Share & Trends Analysis Report By Product (Cell-based Immunotherapies, Gene Therapies), By Therapeutic Category (Cardiovascular, Oncology), And Segment Forecasts, 2021 - 2027", by Grand View Research

Furthermore,advancements in cell biology, genomics research, and gene-editing technology are anticipated to fuel the growth of the industry. Stem cell-based regenerative therapies are in clinical trials, which may help restore damaged specialized cells in many serious and fatal diseases, such as cancer, Alzheimer's, neurodegenerative diseases, and spinal cord injuries. For instance, various research institutes have adopted Human Embryonic Stem Cells (hESCs) to develop a treatment for Age-related Macular Degeneration (AMD).

Constant advancements in molecular medicines have led to the development of gene-based therapy, which utilizes targeted delivery of DNA as a medicine to fight against various disorders. Gene therapy developments are high in oncology due to the rising prevalence and genetically driven pathophysiology of cancer. The steady commercial success of gene therapies is expected to accelerate the growth of the global market over the forecast period.

Grand View Research has segmented the global regenerative medicine market on the basis of product, therapeutic category, and region:

List of Key Players of Regenerative Medicine Market

Check out more studies related to Global Biotechnology Industry, conducted by Grand View Research:

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About Grand View Research

Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead.

Contact:Sherry JamesCorporate Sales Specialist, USAGrand View Research, Inc.Phone: 1-415-349-0058Toll Free: 1-888-202-9519Email: [emailprotected]Web: https://www.grandviewresearch.comFollow Us: LinkedIn| Twitter

SOURCE Grand View Research, Inc.

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The prevalence of inorganic mercury in human cells increases during aging but decreases in the very old | Scientific Reports - Nature.com

Spinal Cord Stem Cells Comments Off on The prevalence of inorganic mercury in human cells increases during aging but decreases in the very old | Scientific Reports – Nature.com | August 19th, 2021

Former Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction, David Lasseter, and Former US Representative Jack Kingston, join newly formed Board Former Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction, David Lasseter, and Former US Representative Jack Kingston, join newly formed Board

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Heat Biologics Announces Formation of Biothreat Advisory Board

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GAINESVILLE, Fla. and CAMBRIDGE, Mass., Aug. 18, 2021 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare retinal diseases, today announced the addition of Yehia Hashad, MD to its Board of Directors.

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AGTC Appoints Ophthalmology and Retinal Disease Specialist and Industry R&D Veteran Yehia Hashad, MD to its Board of Directors

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BOSTON, Aug. 18, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced the treatment of the first patient in a Phase 2a trial of its oral LOXL2 inhibitor GB2064 in myelofibrosis. Myelofibrosis, a form of chronic leukemia, is a rare type of blood cancer in which the normal bone marrow is destroyed by fibrous scar tissue that does not produce blood cells.

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Galecto Announces First Patient Treated in Phase 2a Trial of the Oral LOXL2 Inhibitor GB2064 in Myelofibrosis (the MYLOX-1 Trial)

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SOUTH SAN FRANCISCO, Calif., Aug. 18, 2021 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV), today announced it has selected a fourth core inhibitor candidate, ABI-4334 (4334), that has been optimized for potency, to advance into clinical development. The company is conducting preclinical work, with the aim of completing regulatory filings and initiating clinical studies as soon as possible in 2022.

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Assembly Bio Selects Fourth HBV Core Inhibitor Candidate for Advancement Into Clinical Development

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CAMBRIDGE, Mass., Aug. 18, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (Nasdaq: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, announced today it has appointed Lini Pandite, MBChB, MBA to its board of directors. As a board-certified oncologist and current Chief Medical Officer at Shattuck Labs, Dr. Pandite brings extensive expertise in oncology drug development and clinical application, diversifying the breadth of expertise represented on the board.

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Codiak BioSciences Appoints Lini Pandite, MBChB, MBA to Board of Directors

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GLOBAL CELL & GENE THERAPY SECTOR ON PACE FOR ANNUAL RECORDS IN PRODUCT APPROVALS AND FINANCINGS, SAYS ALLIANCE FOR REGENERATIVE MEDICINE

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Global Cell & Gene Therapy Sector on Pace for Annual Records in Product Approvals and Financings, Says Alliance for Regenerative Medicine

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Third Quarter Revenues Increased by 88% Compared to the Same Period Last Year

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Digipath Announces Results for Third Fiscal Quarter 2021

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Expanded Facility Capacity Provides Additional Growth Working Capital Availability at Low Cost of Capital Expanded Facility Capacity Provides Additional Growth Working Capital Availability at Low Cost of Capital

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Better Choice Company Increases Term-Loan Credit Facility Capacity to $7.5 Million at LIBOR Plus 250 Basis Points

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CHICAGO, Aug. 18, 2021 (GLOBE NEWSWIRE) -- Cosmos Holdings, Inc. (“the Company") (OTCQX: COSM), an international pharmaceutical company with a proprietary line of branded and generic pharmaceuticals, nutraceuticals, OTC medications and medical devices, and an extensive, established European Union distribution network, today announced that the Company has entered into a debt exchange agreement with its senior lender (Lender) to further reduce the Company’s debt. Under the terms of the agreement, the Company will issue the Lender 321,300 shares of common stock at $5.00 per share in exchange for the principal amount of debt of EUR $1.35 million (US $1.60 million). An additional EUR $1.00 million of debt (US $1.19 million) will be converted effective upon approval of listing of the Company’s common stock to Nasdaq Capital Market in exchange for 238,000 shares of common stock at $5.00 per share, or at market value upon listing if the price is above $5.00 per share at the time of conversion. With this conversion, the Company has reduced the remaining balance of its senior debt to EU $350,000 (US $414,000).

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Cosmos Holdings Announces Voluntary Conversion of Debt to Equity by the Company’s Senior Lender, Further Enhancing the Balance Sheet

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ProMIS Neurosciences Inc. Announces Upsize of Previously Announced Public Offering of Units to US$17.5M

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COPENHAGEN, Denmark – August 18, 2021 - Bavarian Nordic A/S (OMX:  BAVA, OTC: BVNRY) will announce its 2021 first half results on Wednesday, August 25, 2021.

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Bavarian Nordic to Host First Half 2021 Results Conference Call and Webcast

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Basel, 18 August 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel, advancing the company's commitment to personalised healthcare through tests that determine which patients are most likely to benefit from specific and targeted therapies. The VENTANA MMR RxDx Panel is the first companion diagnostic test to aid in identifying patients whose solid tumours are deficient in DNA mismatch repair (MMR), who may be eligible for JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD-1 immunotherapy from GSK. The test evaluates a panel of MMR proteins in tumours to provide important treatment information to clinicians.MMR is a naturally occurring mechanism that scans our DNA, correcting errors that cause disease. When MMR is deficient (dMMR), cells mutate, which can lead to cancer. While MMR deficiency is most common in endometrial cancer, other high prevalence dMMR tumour types include gastric, colorectal, small intestine, cervical and neuroendocrine cancers. In the U.S., prevalence of dMMR across patients with solid tumours has been estimated at 14 percent.3 PD-1 inhibitors can be effective treatment in cancers with MMR deficiency."As the first companion diagnostic of its kind, this test can help qualify patients with solid tumours that are deficient in MMR who have progressed in their disease and who have no other suitable treatment options,” said Thomas Schinecker, CEO Roche Diagnostics. “Based on the results of our MMR biomarker test, these patients may be eligible to receive GSK’s JEMPERLI. We are pleased that our innovative companion diagnostic label continues to grow to serve more patients.”FDA approval of the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated panel of MMR biomarkers tested by immunohistochemistry (IHC), enabling impactful treatment decisions for patients. JEMPERLI was approved by the FDA on 17 August 2021 for the treatment of adult patients with dMMR recurrent or advanced solid tumours, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. This indication received accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may depend on verification and description of clinical benefit in a confirmatory trial(s).The VENTANA MMR RxDx Panel and JEMPERLI were earlier approved by the FDA for use in endometrial cancer in April 2021.Read more about Roche innovation in MMR biomarker testing. About the VENTANA MMR RxDx PanelThe VENTANA MMR RxDx Panel is a label expansion of Roche’s current on-market VENTANA MMR IHC Panel. The VENTANA MMR RxDx Panel is intended for the assessment of expression of MMR proteins in formalin-fixed, paraffin-embedded (FFPE) tumour tissue stained with OptiView DAB IHC Detection Kit and ancillary reagents in the panel for VENTANA anti-MLH1 (M1), VENTANA anti-MSH2 (G219-1129) and VENTANA anti-MSH6 (SP93) and OptiView DAB IHC Detection Kit with the OptiView Amplification Kit and ancillary reagents for VENTANA anti-PMS2 (A16-4) on a BenchMark ULTRA instrument. DNA mismatch repair (MMR) proteins have been clinically proven to be predictive biomarkers for PD-1 targeted therapy; specifically, a loss of expression of one or more MMR proteins might predict an increased likelihood of response to such therapy.4,5,6 PD-1 inhibitors can be effective in cancers with MMR deficiency.4,6 MMR is a conserved molecular mechanism that functions to correct the improper base substitutions that spontaneously occur during DNA replication. Defects in the MMR machinery have been attributed to mutations in the MMR proteins.About RocheRoche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.All trademarks used or mentioned in this release are protected by law.References[1] Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020:70(1):7-30.[2] Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019:69(1):7-34[3] Lorenzi M, Amonkar M, Zhang J, et al. Epidemiology of microsatellite instability high (MSI-H) and deficient mismatch repair (dMMR) in solid tumors: a structured literature review. J Oncol. 2020. doi.org/10.1155/2020/1807929[4] Lee YC, S Lheureux, and AM Oza. Treatment strategies for endometrial cancer: current practice and perspective. Curr Opin Obstet Gynecol. 2017:29:47-58.[5] GSK website, https://www.gsk.com/en-gb/media/press-releases/data-from-garnet-study-indicates-robust-activity-of-dostarlimab-in-patients-with-advanced-or-recurrent-endometrial-cancer/[6] Kato M, Takano M, Miyamoto M, et al. DNA mismatch repair-related protein loss as a prognostic factor in endometrial cancers. J Gynecol Oncol. 2015:26(1):40-45.Roche Group Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com

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Roche receives FDA approval for first companion diagnostic to identify dMMR solid tumour patients eligible for anti-PD-1 immunotherapy

Global News Feed Comments Off on Roche receives FDA approval for first companion diagnostic to identify dMMR solid tumour patients eligible for anti-PD-1 immunotherapy | August 19th, 2021

WATERTOWN, Mass., Aug. 18, 2021 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), today announced that the Company granted non-statutory stock options to new employees as inducement awards outside the Company’s 2017 Equity Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4).

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Kala Pharmaceuticals Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

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NEW HAVEN, Conn., Aug. 18, 2021 (GLOBE NEWSWIRE) -- BIOASIS TECHNOLOGIES INC. (TSXV:BTI; OTCQB:BIOAF), (the “Company” or “Bioasis”), a pre-clinical, research-stage biopharmaceutical company developing its proprietary xB3™ platform technology for the delivery of therapeutics across the blood-brain barrier (“BBB”) and the treatment of central nervous system (“CNS”) disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases, today announced the appointment of Shadow Lake Group Inc. and its affiliate SLG Europe BV (“SLG”) as Business Development advisor.

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Bioasis Technologies Inc. Announces the Appointment of Shadow Lake Group as Business Development Advisor

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BOSTON, Aug. 18, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for NUZYRA® (omadacycline) for the treatment of infections caused by Nontuberculous Mycobacteria (NTM). This orphan drug designation includes NTM pulmonary disease caused by Mycobacterium abscessus complex (MABc), which is the focus of an ongoing Phase 2b study initiated by Paratek.The FDA’s Office of Orphan Drug Products grants orphan status to drugs and biologics that demonstrate promise for the treatment of diseases or conditions affecting fewer than 200,000 people in the United States. Orphan drug designation provides Paratek with certain development incentives, including tax credits for qualified clinical testing, exemptions from certain FDA application fees, and potential market exclusivity, if approved.“The orphan drug designation is an important regulatory milestone that further validates our efforts to investigate the utility of NUZYRA, a once-daily, broad-spectrum antibiotic currently approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia, as a potential therapy option for patients afflicted with M. abscessus pulmonary disease, an orphan disease for which there are no approved therapies,” said Randy Brenner, Chief Development and Regulatory Officer of Paratek. “Earlier this year, we initiated our Phase 2b clinical study that is designed to examine the efficacy and safety of NUZYRA in patients with M. abscessus pulmonary disease. These clinical data will continue to build upon the expanding data and publications about NUZYRA and its potential utility in NTM abscessus.About NTM AbscessusPulmonary infections caused by M. abscessus, an orphan disease with no FDA-approved antibiotic therapies, affects approximately 11,500 patients in the United States. Patients with pulmonary disease caused by M. abscessus have a myriad of symptoms including severe fatigue, fever, cough, and shortness of breath. The standard of care typically involves a combination of multiple antibiotics, most of which are intravenous, which can often require life-long treatment that is complicated by long-term tolerability challenges and multiple adverse events.About the Phase 2b NTM StudyThe Phase 2b study is a placebo-controlled, randomized monotherapy study of NUZYRA in patients with M. abscessus pulmonary disease who are in the early treatment phase and are not receiving other antibiotic treatments. The U.S.-based study will enroll approximately 75 subjects, randomized in a 1.5 to 1 ratio. The primary study endpoints are improvement in symptoms and safety and tolerability following 12 weeks of treatment. Due to the small numbers of patients with this orphan disease, Paratek expects the study will take about two years to complete enrollment.More information can be found at clinicaltrials.gov under the study ID number (NCT04922554).About Paratek Pharmaceuticals, Inc.Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.The company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.In 2019, Paratek was awarded a contract from BARDA, valued at ~$285 million, to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax.For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.About NUZYRANUZYRA® (omadacycline) is a novel once-daily antibiotic with both oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.Indications and UsageNUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.Important Safety InformationContraindicationsNUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients.Warnings and PrecautionsMortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.NUZYRA is structurally similar to tetracycline-class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.Adverse ReactionsThe most common adverse reactions (incidence =2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.Drug InteractionsPatients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.Use in Specific PopulationsLactation: Breastfeeding is not recommended during treatment with NUZYRA.To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.Forward Looking StatementsThis press release contains forward-looking statements related to our overall strategy, products, prospects, NTM disease, our clinical studies for NTM, real world data of NUZYRA for NTM patients and the potential for NUZYRA to fill an unmet medical need for NTM patients. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2020 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

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Paratek Pharmaceuticals Announces FDA Orphan Drug Designation for NUZYRA® (omadacycline) for the Treatment of Infections Caused by Nontuberculous...

Global News Feed Comments Off on Paratek Pharmaceuticals Announces FDA Orphan Drug Designation for NUZYRA® (omadacycline) for the Treatment of Infections Caused by Nontuberculous… | August 19th, 2021