In brief

In 2020, the European Commission began a review of the EUs rules on blood, tissues and cells (BTC) used for medical treatments and therapies. Now the Commission haspublisheda draft legislative proposal to amend the rules.

The proposal does not recommend a complete overhaul: the EU will not change its definitions of blood, tissue and cell products. Yet it does promise a significant update to the two Directives published in the early 2000s that continue to govern the use of BTC components in the EU. Most importantly, the proposed legislation would be packaged as a Regulation rather than a Directive, meaning it would have a direct effect in the Member States.

The legislation sets out quality and safety requirements for allactivitiesfrom donation to human application (unless the donations are used to manufacture medicinal products or medical devices, in which case the legislation only applies to donation, collection and testing).

In its press release, the European Commission states that every year, EU patients are treated with 25 million blood transfusions (during surgery, emergency, cancer or other care), a million cycles of medically assisted reproduction, over 35,000 transplants of stem cells (mainly for blood cancers) and hundred thousands of replacement tissues (e.g., for orthopedic, skin, cardiac or eye problems). These therapies are only available thanks to the willingness of fellow citizens to make altruistic donations.

In the EU, the collection, processing and supply of each individual unit is typically organized on a local small-scale by public services, (academic) hospitals and non-profit actors.

Afteralmost 20years in place, the legislationno longer addressesthe scientific and technicalstate of the art and needs to be updated to take into account developments that have taken place in the sector.

How is the Commission planning to change BTC legislation in the EU? Here are three key takeaways from the draft proposal.

Compensating Doctors

The tissue and cell directive currently in force explicitly permits the Member States to compensate donors of tissue and cell products for their trouble. The corresponding blood Directive, however, contains no such provision: in its absence, different countries have developed their own guidelines on blood donor compensation.

That disparity is addressed in the draft Regulation, which would allow the Member States to reimburse donors of all human-derived products for losses related to their participation in adonation through fixed-rate allowances. Improving access to plasma donation, advocates of compensation schemes hope, could help the EU to bolster its patchy stockpiles of the essential fluid.

Emergency Planning

The Covid-19 pandemic demonstrated the fragility of healthcare networks that rely heavily on external sources for their products. Supply chain disruptions are a particular threat to the availability of plasma-derived medicines in the bloc since much of the EUs plasma is imported from the USA.

With this in mind, the Commission wants the Member States to develop emergency plans to cope with supply shocks. Countries would be required to maintain lines of communication that could be used in emergencies, establish authorities responsible for distribution in critical situations, and detect risks to their continued access to substances of human origin.

Detecting Risks

As might be expected, the draft Regulation introduces measures to protect the health and privacy of donors and donees. Screening is mandated to prevent patients from receiving diseased blood or cancerous cells. Technical systems should be in place to preserve the anonymity of all parties to a BTC transfer.

The burden of safeguarding is particularly heavy where assisted reproduction is concerned. It would be up to the Member States, under the draft legislation, to detect and mitigate genetic risks posed by donated reproductive cells.

If approved, it is thought that the revisions will be endorsed by 2023, with implementation beginning in 2024.

For further information, please contact Julia Gillert of our London office.

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EU: New Blood? Proposed Revisions to the EUs Blood, Tissues and Cells Rules - GlobalComplianceNews

Stem Cells Market: Introduction

According to the report, the globalstem cells marketwas valued at US$11.73Bn in 2020 and is projected to expand at a CAGR of10.4%from 2021 to 2028. Stem cells are defined as specialized cells of the human body that can develop into various different kinds of cells. Stem cells can form muscle cells, brain cells and all other cells in the body. Stem cells are used to treat various illnesses in the body.

North America was the largest market for stem cells in 2020. The region dominated the global market due to substantial investments in the field, impressive economic growth, increase in incidence of target chronic diseases, and technological progress. Moreover, technological advancements, increase in access to healthcare services, and entry of new manufacturers are the other factors likely to fuel the growth of the market in North America during the forecast period.

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Asia Pacific is projected to be a highly lucrative market for stem cells during the forecast period. The market in the region is anticipated to expand at a high CAGR during the forecast period. High per capita income has increased the consumption of diagnostic and therapy products in the region. Rapid expansion of the market in the region can be attributed to numerous government initiatives undertaken to improve the health care infrastructure. The market in Asia Pacific is estimated to expand rapidly compared to other regions due to shift in base of pharmaceutical companies and clinical research industries from developed to developing regions such as China and India. Moreover, changing lifestyles and increase in urbanization in these countries have led to a gradual escalation in the incidence of lifestyle-related diseases such as cancer, diabetes, and heart diseases.

Technological Advancements to Drive Market

Several companies are developing new approaches to culturing or utilizing stem cells for various applications. Stem cell technology is a rapidly developing field that combines the efforts of cell biologists, geneticists, and clinicians, and offers hope of effective treatment for various malignant and non-malignant diseases. The stem cell technology is progressing as a result of multidisciplinary effort, and advances in this technology have stimulated a rapid growth in the understanding of embryonic and postnatal neural development.

Adult Stem Cells Segment to Dominate Global Market

In terms of product type, the global stem cells market has been classified into adult stem cells, human embryonic stem cells, and induced pluripotent stem cells. The adult stem cells segment accounted for leading share of the global market in 2020. The capability of adult stem cells to generate a large number of specialized cells lowers the risk of rejection and enables repair of damaged tissues.

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Autologous Segment to Lead Market

Based on source, the global stem cells market has been bifurcated into autologous and allogenic. The autologous segment accounted for leading share of the global market in 2020. Autologous stem cells are used from ones own body to replace damaged bone marrow and hence it is safer and is commonly being practiced.

Regenerative Medicines to be Highly Lucrative

In terms of application, the global stem cells market has been categorized into regenerative medicines (neurology, oncology, cardiology, and others) and drug discovery & development. The regenerative medicines segment accounted for major share of the global market in 2020, as regenerative medicine is a stem cell therapy and the medicines are made using stem cells in order to repair an injured tissue. Increase in the number of cardiac diseases and other health conditions drive the segment.

Therapeutics Companies Emerge as Major End-users

Based on end-user, the global stem cells market has been divided into therapeutics companies, cell & tissue banks, tools & reagents companies, and service companies. The therapeutics companies segment dominated the global stem cells market in 2020. The segment is driven by increase in usage of stem cells to treat various illnesses in the body. Therapeutic companies are increasing the utilization of stem cells for providing various therapies. However, the cell & tissue banks segment is projected to expand at a high CAGR during the forecast period. Increase in number of banks that carry out research on stem cells required for tissue & cell growth and elaborative use of stem cells to grow various cells & tissues can be attributed to the growth of the segment.

Regional Analysis

In terms of region, the global stem cells market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global stem cells market in 2020, followed by Europe. Emerging markets in Asia Pacific hold immense growth potential due to increase in income levels in emerging markets such as India and China leading to a rise in healthcare spending.

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Competition Landscape

The global stem cells market is fragmented in terms of number of players. Key players in the global market include STEMCELL Technologies, Inc., Astellas Pharma, Inc., Cellular Engineering Technologies, Inc., BioTime, Inc., Takara Bio, Inc., U.S. Stem Cell, Inc., BrainStorm Cell Therapeutics, Inc., Cytori Therapeutics, Inc., Osiris Therapeutics, Inc., and Caladrius Biosciences, Inc.

Stem Cells Market, by Application

Stem Cells Market, by End-user

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Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision-makers, made possible by experienced teams of Analysts, Researchers, and Consultants. The proprietary data sources and various tools & techniques we use always reflect the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in all of its business reports.

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Wilmington, Delaware, United States, July 18, 2022 (GLOBE NEWSWIRE) -- Transparency Market Research Inc.: The market value of the global cell separation technologies market is estimated to be over US$ 20.3 Bn by 2031, according to a research report by Transparency Market Research (TMR). Hence, the market is expected expand at a CAGR of 11.9% during the forecast period, from 2022 to 2031.

According to the TMR insights on the cell separation technologies market, the prevalence of chronic disorders including obesity, diabetes, cardiac diseases, cancer, and arthritis is being increasing around the world. Some of the key reasons for this situation include the sedentary lifestyle of people, increase in the older population, and rise in cigarette smoking and alcohol consumption across many developed and developing nations. These factors are expected to help in the expansion of the cell separation technologies market during the forecast period.

Players in the global cell separation technologies market are increasing focus on the launch of next-gen products. Hence, they are seen increasing investments in R&Ds. Moreover, companies are focusing on different strategies including acquisitions and strengthening their distribution networks in order to stay ahead of the competition.

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As per the Imperial College London, chronic diseases are expected to account for approximately 41 million deaths per year, which seven out of 10 demises worldwide. Of these deaths, approximately 17 million are considered to be premature. Hence, surge in cases of chronic diseases globally is resulting into increased need for cellular therapies in order to treat such disease conditions, which, in turn, is boosting the investments toward R&Ds, creating sales opportunities in the cell separation technologies market.

Cell Separation Technologies Market: Key Findings

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Cell Separation Technologies Market: Growth Boosters

Cell Separation Technologies Market: Regional Analysis

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Cell Separation Technologies Market: Key Players

Some of the key players profiled in the report are:

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Cell Separation Technologies Market Segmentation

Modernization of healthcare in terms of both infrastructure and services have pushed the healthcare industry to new heights, Stay Updated with Latest Healthcare Research Reports by Transparency Market Research:

Cell Culture Market: Rise in outsourcing activities and expansion of biopharmaceutical manufacturers are expected to drive the cell culture market during the forecast period

Cell Culture Media, Sera, and Reagents Market: The global cell culture media, sera, and reagents market is majorly driven by growth and expansion of biotechnology & pharmaceutical companies and academic & research institutes.

Stem Cells Market: The global stem cells market is majorly driven by rising applications of stem cells in regenerative medicines. Increase in the number of chronic diseases such as cardiac diseases, diabetes, cancer, etc.

Cell Line Authentication and Characterization Tests Market: Increase in the geriatric population and surge in incidence of chronic diseases are projected to drive the global cell line authentication and characterization tests market.

CAR T-cell Therapy Market: The CAR T-cell therapy market is expected to clock a CAGR of 30.6% during the assessment period. The CAR T-cell therapy is known as a revolutionary treatment option for cancer, owing to its remarkably effective and durable clinical responses.

Cell & Tissue Preservation Market: Rise in investments in the field of regenerative medicine research is estimated to propel the market. Human blood, tissues, cells, and organs own the capability to heal damaged tissues and organs with long-term advantages.

Placental Stem Cell Therapy Market: Placental stem cell therapy market is driven by prominence in treatment of age-related disorders/diseases and increase in awareness about stem cell therapies are projected to drive the global market in the near future.

Biotherapeutics Cell Line Development Market: The market growth will be largely driven by research and development activities due to which, new solutions and technologies have gradually entered the market.

About Transparency Market Research

Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision makers. Our experienced team of Analysts, Researchers, and Consultants use proprietary data sources and various tools & techniques to gather and analyze information.

Our data repository is continuously updated and revised by a team of research experts, so that it always reflects the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports.

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Cell Separation Technologies Market Expands with Rise in Prevalence of Chronic Diseases, States TMR Study - GlobeNewswire

WILMINGTON, Del., July 21, 2022 /PRNewswire/ --An in-depth demand analysis of dental membrane and bone graft substitutes found that massive demand for resorbable bone grafting materials presents value-grab opportunity. Companies in the dental membrane and bone graft substitutes market are actively leaning on development of novel biomaterials to meet the needs of bone grafting procedures. The TMR study projects the size of the market to surpass worth of US$ 1,337 Mn by 2031.

Advancements in periodontology are catalyzing introduction of new soft tissue regeneration, as emerging trends of the dental membrane and bone graft substitutes market underscore. Moreover, dental membrane and bone graft substitutes market projections in the TMR study have found that the use of xenograft for dental bone regeneration is anticipated to rise rapidly, and will unlock lucrative avenues. The fact that xenografts are cost-effective and show good results in bone tissue regeneration will spur the popularity of products in the segment.

Increasing number of bone regeneration procedures has led to the commercialization of novel biomaterials and dental bone grafts. The application of human cell sources in bone graft substitutes is growing, thus extending the canvas for companies in the dental membrane and bone graft substitutes market. Rise in oral disorders and injuries has impelled the need for bone substitute materials that can promise long-term survival rates in the patients.

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Key Findings of Dental Membrane and Bone Graft Substitutes Market Study

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Dental Membrane and Bone Graft Substitutes Market: Key Drivers

Dental Membrane and Bone Graft Substitutes Market: Regional Growth Dynamics

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Dental Membrane and Bone Graft Substitutes Market: Key Players

High degree of fragmentation has characterized the competition landscape in the dental membrane and bone graft substitutes market, mainly due to presence of several prominent players. Some of the key players are Zimmer Biomet, OPKO Health, Inc., NovaBone Products, LLC., Nobel Biocare Services AG, Geistlich Pharma AG, Dentsply Sirona, Collagen Matrix, Inc., BioHorizons, and Institut Straumann AG.

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Dental Membrane and Bone Graft Substitutes Market Segmentation

Regions Covered

Countries

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Non-Invasive Prenatal Testing Market: Non-invasive prenatal testing market was worth around US$ 1.3 Bn in 2018. The market is likely to develop at a CAGR of 16.4% during the forecast period, from 2019 to 2027.

Cell Culture Media, Sera, and Reagents Market: The global cell culture media, sera, and reagents market is majorly driven by growth and expansion of biotechnology & pharmaceutical companies and academic & research institutes.

Stem Cells Market: The global stem cells market is majorly driven by rising applications of stem cells in regenerative medicines. Increase in the number of chronic diseases such as cardiac diseases, diabetes, cancer, etc.

Cell Line Authentication and Characterization Tests Market: Increase in the geriatric population and surge in incidence of chronic diseases are projected to drive the global cell line authentication and characterization tests market.

CAR T-cell Therapy Market: The CAR T-cell therapy market is expected to clock a CAGR of 30.6% during the assessment period. The CAR T-cell therapy is known as a revolutionary treatment option for cancer, owing to its remarkably effective and durable clinical responses.

Cell & Tissue Preservation Market: Rise in investments in the field of regenerative medicine research is estimated to propel the market. Human blood, tissues, cells, and organs own the capability to heal damaged tissues and organs with long-term advantages.

mHealth Monitoring Diagnostic Medical Devices Market: The global mHealth monitoring diagnostic medical devices market was valued at US$ 29.05 Bn in 2018 and is projected to expand at a CAGR of 20.5% from 2019 to 2027.

Pediatric Medical Devices Market: The global pediatric medical devices market was valued at US$ 21,000 Mn in 2017 and is projected to expand at a CAGR of 8.0% from 2018 to 2026.

About Transparency Market Research

Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision makers. Our experienced team of Analysts, Researchers, and Consultants use proprietary data sources and various tools & techniques to gather and analyze information.

Our data repository is continuously updated and revised by a team of research experts, so that it always reflects the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports.

For More Research Insights on Leading Industries, Visit Our YouTube Channel and hit subscribe for Future Update -https://www.youtube.com/channel/UC8e-z-g23-TdDMuODiL8BKQ

Contact :Rohit BhiseyTransparency Market Research Inc.CORPORATE HEADQUARTER DOWNTOWN,1000 N. West Street,Suite 1200, Wilmington, Delaware 19801 USATel: +1-518-618-1030USA Canada Toll Free: 866-552-3453Website:https://www.transparencymarketresearch.comBlog:https://tmrblog.comEmail:sales@transparencymarketresearch.com

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Dental Membrane and Bone Graft Substitutes Market to Exceed Value of US$ 1,337 Mn by 2031 - PR Newswire UK

HTL0039732 is a novel EP4 antagonist with potential to treat a wide range of cancers in combination with other immunotherapies HTL0039732 is a novel EP4 antagonist with potential to treat a wide range of cancers in combination with other immunotherapies

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Cancer Research UK and Sosei Heptares sign agreement to advance cancer immunotherapy candidate into clinical trials

Ad Hoc Announcement Pursuant to Art. 53 LR

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COPENHAGEN, Denmark, July 22, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that the marketing authorization for the Company’s smallpox vaccine, IMVANEX®, is extended to include protecting people from monkeypox disease.

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Garching / Munich, July 22, 2022 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the appointment of Dr. Sebastian Marx to its Executive Board as Chief Business Officer (CBO) of the ITM Group. Dr. Marx joined ITM in 2008 and has since contributed significantly to the company’s growth and development across various product management positions, including Head of Sales. As CBO, Dr. Marx will strengthen the company’s marketing focus as it prepares for the potential product launch of its radiopharmaceutical lead candidate, ITM-11, for the treatment of neuroendocrine tumors (GEP-NETs). In his new role, he will have overall responsibility for marketing and sales, and market access and intelligence for the company’s radioisotopes, radiodiagnostics and radiotherapeutics as well as the further expansion of its global sales partner network.

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Basel, 22 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Vabysmo®? (faricimab) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). Based on this recommendation, a final decision regarding the approval of Vabysmo is expected from the European Commission in the near future.

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CHMP recommends EU approval of Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss

BOSTON, July 22, 2022 (GLOBE NEWSWIRE) -- PepGen Inc. (“PepGen”), a Boston-based clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced the appointment of Caroline Godfrey, Ph.D., one of PepGen’s scientific co-founders, to its Scientific Advisory Board. In connection with this appointment, Dr. Godfrey leaves her position as Senior Vice President of Discovery at PepGen.

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PepGen Appoints Caroline Godfrey, Ph.D. to the Company’s Scientific Advisory Board

Oryzon invests $8.1 million in R&D in the first half 2022 Oryzon invests $8.1 million in R&D in the first half 2022

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ORYZON Reports Results and Corporate Update for Half-Year Ending June 30, 2022

MIAMI, July 22, 2022 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress” or the “Company”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced the appointment of David Jin as Chief Financial Officer effective August 16, 2022. Mr. Jin will also continue to serve as Head of Corporate Development.

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Fortress Biotech Appoints David Jin as Chief Financial Officer

Partner Horus Pharma to launch ILUVIEN for non-infectious uveitis affecting the posterior segment indication later in Q3 Partner Horus Pharma to launch ILUVIEN for non-infectious uveitis affecting the posterior segment indication later in Q3

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CAMBRIDGE, Mass., July 22, 2022 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced that its Senior Vice President and Chief People Officer, Carla Poulson, has been named one of Savoy Magazine’s 2022 Most Influential Black Executives in Corporate America.

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NEW YORK, July 22, 2022 (GLOBE NEWSWIRE) -- Fairway Consulting Group (FCG), a leading recruiting firm focused on providing outstanding talent solutions for the pharmaceutical, biotechnology, diagnostic, and medical device industries, today announced the Company is expanding amid continued growth. In the past 8 years, FCG has nearly tripled its annual placements.

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Fairway Consulting Group Announces Expansion Amid Growth

New York, NY, and Tel Aviv, ISRAEL, July 22, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its majority-owned joint venture 3CL Pharma Ltd. reported the preprint in ResearchGate of case study #8 entitled “A Case Review: Effects of 3CL Protease Inhibitors Paxlovid® and Tollovid™ in a Patient with Chronic Long COVID” overseen by Dr. Lee Morgentaler in concert with Andrew A. Blumenthal, RN ADS of a patient who was experiencing symptoms of Post-Acute Sequelae of COVID (PASC, or “Long COVID”) for 27 months and experienced benefit with a 5-day course of Paxlovid® treatment followed by over 30 days of supplementation with 3CL protease inhibitor immune support dietary supplement Tollovid™. The pre-publication can be viewed at: https://www.researchgate.net/publication/362174359_3CL_Protease_Inhibitors_IN_Chronic_Long_Covid_A_Case_Review_Effects_of_3CL_Protease_Inhibitors_PaxlovidR_and_Tollovid_in_a_Patient_with_Chronic_Long_Covid.

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Todos Medical Announces Preprint of Chronic Long COVID Case Study #8 of Paxlovid® Treatment Followed by Tollovid™  Dietary Supplementation

Conference Call to be held Wednesday July 27, at 9:00am Eastern Time Conference Call to be held Wednesday July 27, at 9:00am Eastern Time

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Alimera Sciences to Report Second Quarter 2022 Financial Results on Wednesday, July 27, 2022, and Provide Corporate Update

Underwriters’ full exercise of option brings gross proceeds to $264.5 million Underwriters’ full exercise of option brings gross proceeds to $264.5 million

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Revolution Medicines Announces Closing of Upsized Public Offering of Common Stock and Full Exercise of Underwriters' Option to Purchase Additional...

EDISON, N.J., July 22, 2022 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical mid-stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and hepatocellular carcinoma (“HCC”), announced today that its 2022 annual meeting of stockholders (the “Annual Meeting”) has been further adjourned to Friday, August 5, 2022 at 9:00 a.m. Eastern Time with respect to Proposal 4 (Authorized Share Increase), as described in Hepion’s definitive proxy statement filed with the U.S. Securities and Exchange Commission (the “SEC”) on April 29, 2022 (the “Proxy Statement”).

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Hepion Pharmaceuticals Announces Further Adjournment of Annual Meeting of Stockholders

ORLANDO, FL, July 22, 2022 (GLOBE NEWSWIRE) -- Immune Therapeutics, Inc. (OTC Pink: IMUN) (“Immune” or “IMUN”), a specialty pharmaceutical company involved in the acquisition, development and commercialization of pharmaceutical and biotechnology products that have a short and well-defined path to market, is pleased to announce the appointment of Dr. Stephen “Steve” Wilson as Immune’s Chief Executive Officer (CEO), President, and interim Chief Financial Officer (CFO) effective July 19, 2022; he will continue to serve as a member of the Company’s Board of Directors.

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Immune Therapeutics, Inc. Appoints Dr. Stephen Wilson as Chief Executive Officer