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CBER director Peter Marks says 2023 will be a transition year for the Center as it staffs up to do more work on cell and gene therapy and reorganizes its organizational structure and business practices to meet the new demands. Marks discussed the changes during an appearance on Cell &
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A 5/31-6/6/22 FDA inspection at the Palm Beach Fertility Center operated by Dr. Mark Denker in Boca Raton, FL, documented significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A just-released 11/17/22 Warning Letter says specific deviations
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Former FDA commissioner David Kessler, who became chief science officer for the Biden administration’s Covid-19 response, had words of praise for CBER director Peter Marks and his role in the government’s activities. In a lengthy interview with Politico, his first since leaving government a few weeks ago,
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FDA has approved a Takeda supplemental BLA for an expanded use of Takhzyro (lanadelumab-flyo) — prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients aged two to 11 years of age. Previously, the drug was approved for prophylaxis treatment in adults and children aged six to 11 years.
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FDA has accepted for filing a Sandoz BLA for a biosimilar version of Amgen’s denosumab (Prolia and Xgeva), which includes all indications for the reference drugs, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal-related complications in
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The Government Accountability Office (GAO) says that as HHS develops a new program to improve domestic infrastructure and expertise to produce medical countermeasures such as drugs and vaccines in response to public health emergencies, it should incorporate an approach to systematically assess and respond to known challenges and risks associated
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CBER has published its 2023 guidance agenda listing 11 guidances in two categories that it is considering for development during the current calendar year. The agenda lists six possible guidances under Blood and Blood Products and five guidances under Tissues and Advanced Therapies.
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After more than 22 years at FDA, CBER Office of Tissues and Advanced Therapies director Wilson Bryan is retiring in March. Bryan is a neurologist by training and graduated from the University of Chicago Pritzker School of Medicine. Before coming to FDA, he served on the neurology faculty at the
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FDA commissioner Robert Califf and CBER director Peter Marks say biological therapies should be subject to adequate randomized controlled trials (RCTs) before receiving FDA approval. Writing in Science Translational Medicine, Califf and Marks say the “reasons for requiring adequate, reliable evidence demonstrating that the benefits of a proposed intervention outweigh
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FDA’s Vaccines and Related Biological Products Advisory Committee 1/26 unanimously voted (21 to 0) to recommend that Covid-19 vaccine composition be “harmonized” so that one vaccine composition can cover the primary series in newly vaccinated and booster doses in those already vaccinated. For example, if FDA moves
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New emails released by FDA provide a glimpse of a frustrated senior FDA vaccine official arguing why her office could not “compress” its review activities any more to further expedite the 8/23/2021 approval of Pfizer-BioNTech’s Covid-19 vaccine Comirnaty for use in individuals 16 years of
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FDA is proposing to move to a flu vaccine-type model to have its vaccines advisory committee annually select Covid-19 strains in June for immunizations beginning no later than September each year. The agency says that if a serious “pathogenic vaccine-escape variant” begins circulating then an ad-hoc
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FDA has released a draft guidance entitled “Mpox: Development of Drugs and Biological Products.” The document provides nonclinical, virology, and clinical considerations for mpox drug development programs, and it includes recommendations to support initiation of clinical trials. The guidance notes that preventive vaccines are not addressed in the document because
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FDA has issued Eli Lilly a complete response letter for its accelerated approval BLA submission for donanemab, indicated for treating early symptomatic Alzheimer’s disease. FDA’s rejection letter took issue with the “limited number of patients with at least 12 months of drug exposure data provided in the submission,
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Janssen and its global partners say they are ending the Phase 3 Mosaico HIV vaccine trial following an independent, scheduled data review that found the regimen was not effective in preventing HIV infection compared to a placebo among study participants. A Janssen statement says no safety issues with the vaccine
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Moderna says it will seek regulatory approval in the first half of this year for its MRNA-1345, an investigational respiratory syncytial virus (RSV) vaccine for older adults that met its primary endpoints in a Phase 3 trial. A company statement says the successful endpoints included vaccine efficacy of 83.
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The Western Texas federal court has granted an FDA motion to dismiss a lawsuit brought against the agency by a group of parents and the Children’s Health Defense who opposed the Covid-19 vaccines’ emergency use authorizations (EUAs) for use in children. In granting FDA’s motion, the court
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FDA and CDC say a recent potential safety signal suggesting Pfizer’s bivalent Covid-19 vaccine may cause ischemic stroke in people aged 65 and older has not been validated after looking at various vaccine clinical trial and surveillance databases. The agencies note that the signal has not been identified
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FDA Vaccines and Related Biological Products Advisory Committee member Paul Offit, who is affiliated with the Vaccine Education Center at Children’s Hospital of Philadelphia and the University of Pennsylvania’s Perelman School of Medicine, says a lesson learned from the experience with bivalent Covid-19 booster shots is to
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FDA has issued Biocon Biologics a complete response letter on its BLA for a biosimilar version of insulin aspart. The letter cites additional data needing to be submitted and confirmation that a corrective and preventive action plan has been implemented to address findings from a preapproval inspection at two Bangalore,
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Physician advocacy group Doctors for America is urging FDA to commit to convening an advisory committee meeting when it is time to consider the full approval of Biogen/Eisai’s Alzheimer’s therapy Leqembi (lecanemab).The group says it was concerned about the recent FDA decision to “expeditiously approve lecanemab
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Some members of FDA and Centers for Disease Control vaccine advisory committees are “angry” and “disappointed” that neither the government nor Moderna presented some Moderna Covid-19 booster shot infection data when the advisors considered at meetings in 6/2022 and 9/2022 whether the booster should be authorized and