Biologics
Three Morrison Foerster attorneys say a recent Connecticut federal court decision involving Merck’s Gardasil “makes clear there is a high bar for successfully pleading vaccine products liability cases.” The attorneys write that the decision is one of the first major vaccine preemption decisions since FDA authorized Covid-19 vaccines.
Biologics
FDA has approved an Amneal Pharmaceuticals BLA for bevacizumab-maly, a biosimilar referencing Genentech’s Avastin. The product will be marketed under the proprietary name Alymsys. The therapy was developed by mAbxience, a global biotech company claiming over 10 years of experience in developing and manufacturing biopharmaceuticals. The biosimilar is
Biologics
FDA has extended by three months its review of a Regeneron Pharmaceuticals BLA for Regen-Cov (casirivimab and imdevimab) for treating Covid-19 in non-hospitalized patients and as prophylaxis in certain individuals. “The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use, for which
Biologics
Pfizer and BioNTech say they will seek FDA approval for a booster shot of their Covid vaccine for children ages 5-11. The companies say trial data demonstrate a high immune response following a booster dose in the age group. A Pfizer statement says there was a 36-fold increase
Biologics
FDA has granted Merck a breakthrough therapy designation for V116, an investigational 21-valent pneumococcal conjugate vaccine. It is being evaluated for preventing invasive pneumococcal disease and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20,
Biologics
Aeglea BioTherapeutics has submitted a BLA for pegzilarginase for treating Arginase 1 Deficiency (ARG1-D). The company says the recombinant human arginase 1 enzyme has been shown in clinical trials to normalize the elevated levels of the amino acid arginine in patients with ARG1-D. It says people living with
Biologics
FDA has placed a clinical hold on an Ocugen Phase 2/3 immuno-bridging and broadening study for its Covid-19 vaccine Covaxin (BBV152). “This is a result of the company’s decision to voluntarily implement a temporary pause in dosing participants while it evaluates statements made by the World
Biologics
FDA has authorized a shelf life extension for Janssen’s refrigerated Covid-19 vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months. The vaccine was previously authorized to be stored for up to nine months. This extension applies to all refrigerated vials that have
Biologics
CBER director Peter Marks says there are steps FDA and other stakeholders could take that would expedite the development of gene therapies. Writing in Expert Opinion on Biological Therapy, Marks says one place to start would be to consider whether the current framework for the development of small molecule drugs
Biologics
FDA officials told the agency’s Vaccines and Related Biological Products Advisory Committee 4/6 that a decision will likely be made in June on whether a new Covid-19 booster composition is needed by November for what some health experts predict could be another Covid infection wave as people
Biologics
An FDA advisory committee is scheduled 4/6 to discuss what is the optimal strain composition for Covid-19 vaccines to address emerging variants. According to a just-posted briefing document, the panel will also discuss when and how frequently to consider strain composition changes, and what is the optimal
Biologics
Y-mAbs Therapeutics has re-submitted a BLA for omburtamab to treat patients with CNS/leptomeningeal metastases from neuroblastoma after what it characterizes as a positive pre-BLA meeting with FDA reviewers. In 10/2020, FDA issued a refuse-to-file letter on the therapy due to deficiencies with the
Biologics
FDA has issued an immediately effective update to its 5/2021 guidance Emergency Use Authorization for Vaccines to Prevent Covid-19. The document provides the agency’s current thinking on the data and information needed to support the issuance of an emergency use authorization for an investigational vaccine to prevent
Biologics
Outlook Therapeutics has submitted a BLA for Lytenava (bevacizumab-vikg) for treating wet age-related macular degeneration (wet AMD). “If approved, Lytenava could replace the current practice of using unapproved repackaged IV [intravenous] bevacizumab sourced from compounding pharmacies for the treatment of wet AMD,” the company says. The submission is
Biologics
FDA has authorized a second booster dose of the Pfizer/BioNTech and Moderna Covid-19 vaccines for older people and certain immunocompromised individuals. The agency says the action will make a second booster shot available to other populations at higher risk for severe disease, hospitalization, and death. “Emerging evidence suggests
Biologics
FDA has extended by three months its review of a Bristol-Myers Squibb supplemental BLA for Reblozyl (luspatercept-aamt) for treating anemia in adults with non-transfusion-dependent beta thalassemia. The submission was based on safety and efficacy results from the pivotal Phase 2 BEYOND study. The company says it
Biologics
Former CBER Office of Vaccines Research and Review (OVRR) deputy director Philip Krause has joined Mesoblast’s board of directors. Mesoblast says Krause’s “biologics development and regulatory expertise that he brings will be invaluable in our ongoing FDA interactions on our lead and follow-on product candidates.” In 2020,
Biologics
FDA has granted breakthrough designation for Pfizer’s respiratory syncytial virus (RSV) vaccine candidate to prevent lower respiratory tract disease caused by RSV in individuals age 60 and older. The company says the designation was primarily informed by the positive results of a proof-of-concept Phase 2a study evaluating
Biologics
Moderna says it will ask FDA for an emergency use authorization (EUA) for its mRNA-1273 Covid-19 vaccine dosed for children 6 months to under 6 years old. The company says it also has started a submission with FDA for a Covid-19 vaccine EUA for children 6 to
Biologics
The American Medical Association (AMA) has bestowed its Award for Outstanding Government Service on CBER director Peter Marks, recognizing his leadership during the Covid-19 pandemic. “Dr. Marks has worked tirelessly throughout the Covid-19 pandemic to make sure the Covid-19 vaccine development process was transparent, based on rigorous
Biologics
FDA has announced a 4/6 virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss considerations for future Covid-19 vaccine booster doses and the process for selecting specific coronavirus strains for vaccines to address current and emerging variants. The agency says no product-specific discussion
Biologics
Moderna has submitted an Emergency Use Authorization (EUA) amendment to permit an additional Covid-19 vaccine booster (fourth dose) in adults 18 years of age and older who have received an initial booster of any of the authorized or approved vaccines. “The request to include adults over 18 years of