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Republican leaders of the House Select Committee on the Coronavirus Pandemic are asking FDA for information, communications, and transcribed interviews addressing possible political interference in Covid-19 vaccine and booster approvals. “According to new internal FDA communications,” the lawmakers wrote (contains link to letter) to FDA commissioner Robert Califf, “it
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FDA has amended the emergency use authorization (EUA) for the Pfizer-BioNTech Covid-19 bivalent vaccine and its use as a single booster dose to include children aged six months through four years at least two months after completing their primary vaccination with three doses of the monovalent vaccine. Previously
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FDA and CDC sent a 3/10 joint letter to Florida surgeon general Joseph Ladapo to correct “misinterpretations and misinformation” about Covid-19-related data from the Vaccine Adverse Event Reporting System (VAERS) cited in an earlier letter from Ladapo to the agencies. The letter took issue with Ladapo’s
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FDA has approved a Coherus BioSciences BLA for a single-dose, prefilled autoinjector presentation of its Udenyca (pegfilgrastim-cbqv), a biosimilar of Amgen’s Neulasta that is administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. “The introduction of the autoinjector option for
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FDA commissioner Robert Califf says truth is “losing the [misinformation] battle right now” and FDA and many other stakeholders can and must do more to try to protect people from medical misinformation. In an interview with the online newsletter Stat News, Califf said the agency may need to update its
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FDA has accepted a Mesoblast BLA resubmission for remestemcel-L for treating children with steroid-refractory acute graft versus host disease (SR-aGVHD). The agency has set a user fee review action target date of 8/2. In 2020, FDA issued a complete response letter on the original BLA and
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An FDA review of the Web site operated by Thomas Advanced Medical and other materials indicated that the firm is marketing products derived from either human umbilical cord, umbilical cord blood, or amniotic tissue, which the company refers to as “regenerative therapy solutions” or “stem cell derived biological products.” A
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FDA has accepted for review a Regeneron Pharmaceuticals supplemental BLA for Dupixent (dupilumab) for treating adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with the current standard of care (H1 antihistamine treatment). The company describes CSU as an inflammatory skin
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FDA has accepted for priority review an Eisai and Biogen supplemental BLA for Leqembi (lecanemab-irmb) 100 mg/mL injection that is intended to support the conversion of the therapy’s 1/6 accelerated approval to a traditional approval for treating Alzheimer’s Disease (AD). The agency has set a
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FDA commissioner Robert Califf and CBER director Peter Marks are airing their disagreement with Children’s Hospital of Philadelphia Vaccine Education Center director Paul Offit over Covid-19 vaccine strategy in a series of letters in the New England Journal of Medicine. In a 2/9 Perspective, Offit cited preliminary
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CBER’s Office of Therapeutic Products has announced a 4/27 public listening meeting to receive input on methods and approaches (e.g., real-world evidence (RWE), registries) for capturing post-approval safety and efficacy data for cell and gene therapy products. “With an increasing number of cell and gene
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FDA’s Vaccines and Related Biological Products Advisory Committee 3/1 voted 10 to 2 and 12 to 0, respectively, that safety data and effectiveness data were adequate to support approval of GSK’s vaccine Arexvy (RSVPreF3-AS01E) for preventing lower respiratory tract disease caused by respiratory syncytial virus (RSV)
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FDA’s Vaccines and Related Biological Products Advisory Committee 2/28 voted (7 to 4) that Pfizer’s BLA data are adequate to support approval of respiratory syncytial virus bivalent vaccine RSVpreF (PF-06928316). The vaccine is being reviewed by FDA for preventing acute respiratory disease and lower respiratory tract
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FDA has proposed that Pfizer include Guillain-Barré syndrome (GBS) and other immune-mediated demyelinating conditions in a pharmacovigilance plan (PVP) if the company’s BLA for Abrysvo (RSVpreF) is approved. The company is seeking an indication for preventing acute respiratory disease and lower respiratory tract disease caused by Respiratory
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Pfizer and BioNTech have submitted a supplemental BLA that seeks approval of their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine for use as a primary series and booster dose for individuals 12 years of age and older. The submission adheres to last month’s Vaccines and Related
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FDA has approved a Bioverativ Therapeutics (a Sanofi company) BLA for Altuviiio (efanesoctocog alfa), a recombinant DNA-derived, factor VIII concentrate indicated for use in adults and children with hemophilia A. The drug is approved for routine prophylaxis to reduce bleeding episodes, on-demand treatment and control of bleeding episodes,
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CBER director Peter Marks says principles implemented during the Covid-19 pandemic may have implications for the future development of vaccines and possibly other medical products, “ushering in the start of a new era in regulation.” Writing in Expert Review of Vaccines, Marks says that in setting out to rapidly
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Pfizer has informed FDA it has decided to drop a significant percentage (about 50%) of U.S. participants enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) Phase 3 study. A company statement says the participants are being dropped following violations of good clinical practice requirements at certain clinical
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The FDA MCMi Program Update annual report describes the agency’s efforts to ensure that medical countermeasures (MCMs), such as drugs, vaccines, and diagnostic tests, are safe, effective, and secure as they protect the U.S. from chemical, biological, radiological, nuclear (CBRN), and emerging infectious disease threats. The report says
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CBER Office of Tissues and Advanced Therapies director Wilson Bryan, who has announced his retirement from the agency, is concerned about accelerated approvals for cell and gene therapies considering how long it can take to complete confirmatory trials, according to a Bloomberg Law report. Speaking 2/13 at the Biopharma
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CBER director Peter Marks told the Biopharma Congress on 2/13 that he wants to see something similar to the agency’s Project Orbis cancer program developed for cell and gene therapies as the involvement of other “high-income countries” could help attract developers. The FDA Oncology Center of Excellence
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A new journal article by CBER reviewers that looked at 24 advisory committee meetings held to discuss benefit-risk issues between 2009 and 2021 found that the two most frequently discussed considerations were “uncertainty about assessment of the safety profile” and “uncertainty about assessment of the benefit based on clinical