Valneva and IDT Biologika Agree on Termination of their COVID-19 Collaboration

Saint-Herblain (France) and Dessau-Roßlau (Germany), September 16, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and IDT Biologika today announced they have agreed to terminate their collaboration following the delivery of inactivated COVID-19 bulk vaccine to Valneva, and considering the current order levels and existing inventories.

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Valneva and IDT Biologika Agree on Termination of their COVID-19 Collaboration

Ocugen Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

MALVERN, Pa., Sept. 16, 2022 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the Compensation Committee of the Board of Directors of Ocugen approved the grant of stock options to purchase an aggregate of 148,800 shares of its common stock and restricted stock units (RSUs) covering an aggregate of 40,092 shares of common stock to five newly hired team members. The stock options and RSUs were granted as of September 16, 2022, as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

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Ocugen Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

European Commission approves Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss

Basel, 19 September 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) approved Vabysmo® (faricimab) for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). These retinal conditions are two of the leading causes of vision loss worldwide, affecting more than 40 million people 1,2,3,4

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European Commission approves Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss

Sandoz announces further progress on its biosimilar pipeline, with release of positive results for denosumab integrated Phase I/III clinical trial  

Basel, September 19, 2022 – Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announces further progress on its biosimilar pipeline, with the release of positive results from the integrated ROSALIA Phase I/III clinical trial study for its proposed biosimilar denosumab.

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Sandoz announces further progress on its biosimilar pipeline, with release of positive results for denosumab integrated Phase I/III clinical trial  

GENFIT to Acquire Clinical-stage Biopharmaceutical Company Versantis, expanding its Portfolio in Liver Diseases

Lille, France; Cambridge, MA; September 19, 2022 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, today announced it has entered into an exclusivity agreement with a view to acquire all the share capital and voting rights of Versantis, a private Swiss-based clinical stage biotechnology company focused on addressing the growing unmet medical needs in liver diseases.

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GENFIT to Acquire Clinical-stage Biopharmaceutical Company Versantis, expanding its Portfolio in Liver Diseases

Stem Cell Therapy for Eye Disease: What You Need to Know

Avoid Unlicensed Clinics Offering Unapproved Stem Cell Therapy

Stem cell therapies are getting headlines for their potential to cure diseases, including those that affect vision. But an important message is missing: the therapies are not yet proven to be safe and effective for your eyes.

Stem cell treatments appear to offer hope to people with few options to recover vision. This includes people with forms of age-related macular degeneration (AMD), retinitis pigmentosa (RP), and Stargardt disease. Some clinics across the United States offer "stem-cell therapy" to people outside of clinical trials. But the Food and Drug Administration (FDA) has not approved the treatments they offer. These treatments often use unproven products that may be ineffective or dangerous. These products may carry serious risks, including tumor growth.

It is important that you know that there are no stem cell products approved by the FDA for eye disease right now. If you want stem cell therapy, look for a clinical trial and discuss the matter with your ophthalmologist. A clinic should not expect you to pay thousands of dollars for an unproven, unapproved therapy. Your health insurance will not cover the cost of an unapproved treatment.

Before agreeing to a stem cell treatment, ask yourself:

It is frustrating and frightening to face the loss of vision while waiting for potential treatments. However, choosing to pursue an unproven treatment in an unlicensed clinic is an unacceptable risk to your vision and your overall health.

The American Academy of Ophthalmology wants to reduce or eliminate unlicensed stem cell clinics in the United States. In June 2016, the Academy asked the FDA to tighten regulations and increase investigations into stem cell treatments given outside of clinical trials.

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Stem Cell Therapy for Eye Disease: What You Need to Know

How Does Stem Cell Therapy Work and What Are the Risks? | ISCRM

Human stem cells are essential for the growth and maintenance of our organs, bones, and systems. They are also amazing tools of discovery for scientists at the Institute for Stem Cell and Regenerative Medicine and researchers around the world studying how to stop diseases. However, predatory businesses across the country are misusing the term stem cells to market unapproved, unproven, and unsafe procedures that are often expensive and largely ineffective. Its important to understand what stem cell therapy really means.

Lets start by creating two categories of stem cell therapies approved (by the FDA) and unapproved. Whether a stem cell therapy is approved or unapproved has critical implications for the science, effectiveness, and safety of the procedure.

(In addition to blood stem cell transplants), the FDA lists a limited number of additional approved products on its website.)

More recently, hundreds of businesses around the country referring to themselves as clinics have begun marketing various versions of stem cell therapy that promise to help patients with serious conditions like Parkinsons disease and more common ailments like joint pain. In reality, most of these types of stem cell therapy do not use stem cells at all. Rather, they remove tissues that presumably contains adult stem cells from one body part and inject those cells into another part of the body.

Furthermore, there is no proof that any stem cell therapy offered by stem cell clinics is effective or safe. Unlike FDA-approved procedures, which are subject to years of rigorous trials, unapproved treatments marketed directly to patients are developed and performed with little oversight. While stem cell clinics often tout testimonials from satisfied customers, there has never been a large-scale clinical trial to demonstrate that the perceived benefits of a stem cell therapy arent the result of a placebo effect. In recent years, the FDA has begun to expand regulations and enforcement of these clinics.

Thanks to decades of data, we know much more about the effectiveness of blood stem cell transplants. We also know they are not instant cures. While the procedure itself only lasts a few hours, recovery can take weeks. During this period, patients are monitored closely by physicians and nurses for side effects and for evidence of recovery.

There are side effects associated with approved and unapproved stem cell therapies. The possible side effects of blood stem cell transplants are detailed on the Cancer.org website. Patients considering an unapproved stem cell therapy should be aware that these procedures carry serious risks and that these risks may not be managed by a qualified care team. Injecting even a persons own tissue in a different body part has resulted in severe illness and, in some cases, blindness.

Therapies offered by stem cell clinics come with financial risk as well. Because these procedures are generally not covered by insurance, people seeking treatment are required to pay large out-of-pocket fees with no guarantee of improved health.

In their advertising, stem cell clinics promise unsubstantiated relief or even cures for everything from knee pain to Parkinsons disease, often taking advantage of vulnerable individuals who may feel they have nowhere else to turn. In reality, there is no strong evidence to back up claims that any stem cell therapy works let alone has lasting benefits.

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How Does Stem Cell Therapy Work and What Are the Risks? | ISCRM

CellResearch Corporation (CRC) announces positive results of Phase I study for CorLiCyte – PR Newswire

SINGAPORE, Sept. 16, 2022 /PRNewswire/ --CellResearch Corporation, a Singapore-based biopharmaceutical company today announced it has successfully closed the first Phase I study in CorLiCyte, a stem cell therapy derived from umbilical cord lining stem cells, with research partners at the University of Colorado, Anschutz Medical Campus and ClinImmune Cell and Gene Therapy.

CorLiCyte is in development for the treatment of a number of serious conditions, with a first target indication of treating diabetic foot ulcer (DFU). In the study protocol nine patients with chronic DFU were treated with CorLiCyte twice weekly for 8 weeks. None of the patients participating in the study experienced any treatment-related adverse events and all subjects saw a reduction in wound size during the treatment period.

"These results are encouraging and can be used to support further research with CorLiCyte in future studies, with the potential to address unmet medical needs in treatment of patients with chronic DFUs." said Cecilia Low-Wang, the lead investigator at the University of Colorado, Anschutz Medical Campus.

About CorLiCyte

CorLiCyte is a live mesenchymal stem cell therapy derived from human umbilical cord lining stem cells, with a proprietary optimised expression of cytokines, growth and cellular factors for the treatment of a number of serious health conditions. In addition to DFU, CRC is pursuing a range of potential indications at pre-clinical stage such as osteoarthritis, venous leg ulcers, chronic inflammatory and autoimmune conditions.

About CellResearch Corporation

CellResearch Corporation (CRC) was founded in 2002 as a contract research provider focusing on skin cells. In 2004, the company made the discovery that the umbilical cord lining of mammals was an abundant source of both mesenchymal and epithelial stem cells. Today, the company owns this technology through a family of patents and holds the rights to commercialise this technology in most major markets globally.

CellResearch Consumer Health (Formerly known as CALECIM Cosmeceuticals) is a wholly owned subsidiary of CRC and produces an innovative range of skin and hair care products using cord lining stem cell media to power its products. It is used in medical hair and aesthetic clinics for in-office treatments and as part of an at-home anti-aging skincare regime. It is distributed globally through over 600 aesthetic physicians and online via its own website. It has a key distribution partnership with Menarini Group across South East Asia.

CRC partner, Cordlife offers parents the opportunity to bank their child's umbilical cord tissue alongside their cord blood. Cordlife has what is believed to be the largest licensed bank of umbilical cord tissue globally. As cell therapies move into the clinic, Cordlife will have the ability to expand stem cells from a banked umbilical cord for autologous and donor-related uses.

Contact:

Business Development and Investor Relations: Xavier Simpson Tel: +65 8815 6139 Email: [emailprotected]

http://www.cellresearchcorp.com http://www.calecimprofessional.com

SOURCE CellResearch Corporation

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CellResearch Corporation (CRC) announces positive results of Phase I study for CorLiCyte - PR Newswire

Predicting the Treatment Evolution of Hemophilia B – Managed Healthcare Executive

Steven Pipe, MD, describes his hopes for Hemophilia B treatment in the future.

EP. 1 : An Overview of Hemophilia B

EP. 2 : The Economic Burden of Hemophilia B From a Payer Perspective

EP. 3 : Defining the Impact of Gene Therapy

EP. 4 : Managing Hemophilia B Using Gene Therapy

EP. 5 : Predicting the Treatment Evolution of Hemophilia B

Steven Pipe, MD: The current platform looks promising for durable correction in factor 9 levels that are sufficient to prevent most bleeding events and improve health-related quality of life, with a substantial elimination of the economic and personal treatment burden associated with factor 9 prophylaxis. However, with the eligibility limitations we've also indicated, the biggest one, for me, is that this is only for adults. By adulthood, a substantial portion of patients already have established joint disease. We would have a much bigger impact from gene therapy if we could do an earlier intervention in the pediatric age group. Unfortunately, with the way the AAV mechanism occurs by targeting the liver, the DNAthat's the transientis delivered into the nucleus and remains episomal, which means it's primarily outside of the genome. When dividing liver cells, the transgene doesn't get propagated to the daughter cells. What that would mean is, if we did AV in a pediatric age group with a growing, dividing liver, the effect of the gene therapy will be deluded over time. We need different approaches for gene therapy to impact the pediatric age group.

Some of the things I've seen that show promise are non-viral approaches. By using a non-viral approach, you have the option to re-treat patients. That is not an option for patients who get current AV therapy because once you've delivered the AV once, the immunological consequences of that would preclude getting another AV dose sometime later. Right now, we're asking patients to make a once-in-a-lifetime treatment decision to receive gene therapy, but other approaches could also involve gene editing. When you do gene editing, you're either inserting the transgenes somewhere in the genome or modifying the factor 9 gene in such a way that you can restore factor 9 expression. Because you're editing directly in the genome, that would be propagated to daughter cells in a dividing liver. I'm already seeing some new protocols come to the forefront [that will be implemented] in the clinic soon. If these show their utility in adult patients, we'll see that these offered to younger and younger patients and, hopefully, the pediatric age groups where we can completely abrogate the development of joint disease.

The other thing I'm excited about is the evolving treatment landscape as applied to hemophilia B, not just invested in gene therapy approaches. There are several innovative treatment platforms that have been tested over the last few years. The ones I'm particularly excited about are non-factor placement therapies. These are cross-platform therapeutics that can work for hemophilia A or B regardless of whether the patient has had any prior inhibitor development to the factor 8 or factor 9 proteins. These primarily target the natural anticoagulants of the hemostatic process. They rebalance hemostasis without replacing the factor 9 molecule. Data that was presented at this most recent ISTH Congress [International Society of Thrombosis and Haemostasis] in July of this year showed encouraging results that can be applied to patients with hemophilia B. These are treatments that can be delivered subcutaneously. They have a lower intensity. Some of them are given either weekly, monthly, or once every other montha low burden of treatment. They [provide] effective prophylaxis that, in some studies, is superior to traditional factor 9 replacement therapy. I'm excited about the evolving treatment landscape. Hemophilia B gene therapy [carries] great promise, but these other novel therapeutics are hopefully going to be available to us in the clinics quite soon.

Transcript edited for clarity.

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Predicting the Treatment Evolution of Hemophilia B - Managed Healthcare Executive