Biologics
HHS is removing CDC Covid-19 vaccine recommendations for healthy children and healthy pregnant women from the agency’s recommended immunization schedule. In a post on X, HHS secretary Robert F. Kennedy Jr., FDA commissioner Marty Makary and NIH director Jay Bhattacharya complained that the Biden administration urged the vaccines
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FDA says it is advising Covid-19 vaccine makers to formulate their products to match the currently circulating JN.1-lineage and preferentially using the LP.8.1 Covid strain for booster shots beginning in the fall (2025-2026). The recommendation followed a 5/22 Vaccines and Related Biological Products
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Moderna 5/21 announced that at FDA’s urging, it voluntarily withdrew a pending BLA for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older. The company plans to resubmit the BLA later this year, after vaccine efficacy data from the ongoing Phase 3
Biologics
FDA is telling Pfizer and Moderna to expand the label Warnings for their mRNA Covid-19 vaccines (Pfizer’s Comirnaty and Moderna’s Spikevax) to describe the risk of a possible heart injury side effect, primarily in teen boys and young men. CBS News reports that the expanded Warning reflects
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In what is seen as a major shift in its Covid-19 vaccine strategy, FDA is announcing a more targeted regulatory framework for annual booster shots that focuses on protection for high-risk individuals and calling for new clinical trials to evaluate the vaccines’ benefits in healthy Americans. Since the
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FDA has designated Formycon’s FYB202/Otulfi (ustekinumab-aauz) as an interchangeable biosimilar to Janssen’s reference biologic Stelara (ustekinumab) for treating psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis. Ustekinumab is a human monoclonal antibody that selectively targets the p40 protein, a component
Biologics
FDA is planning to release in the “coming days” a vaccine development framework for manufacturers, commissioner Marty Makary told the Food and Drug Law Institute (FDLI) at its annual meeting in Washington, DC 5/15. The framework will outline a development roadmap for vaccine makers so they have a “predictable
FDA Policy/General
FDA and HHS have launched a public Request for Information to “identify and eliminate outdated or unnecessary regulations.” An FDA statement says the initiative is part of a broader federal effort to reduce regulatory burdens and increase transparency in line with President Donald J. Trump’s Executive Order on “Unleashing
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U.S. health officials have issued a temporary pause on the use of Valneva's chikungunya vaccine Ixchiq in individuals aged 60 and older following reports of serious adverse events, including two deaths. FDA and CDC say they are investigating 17 cases of severe side effects reported globally in
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New CBER director Vinay Prasad says he is not “anti-vax” and promises that the Center will strive to “always strike the balance between data, evidence, innovation and entrepreneurial spirit of America.” In a 5/8-posted video conversation co-hosted by FDA commissioner Marty Makary and FDA Policy and
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Appearing on MSNBC 5/9, FDA commissioner Marty Makary said discussions are continuing with Novavax on its BLA to convert a 2022 emergency use authorization to a full approval for its Covid-19 vaccine. The agency missed a user fee target date last month, which the company said was related
FDA Policy/General
FDA commissioner Michael Makary says the agency will expand the use of artificial intelligence (AI)-assisted scientific reviews across all Centers by 6/30. In a statement, he says the rollout follows the successful completion of a new generative AI pilot for scientific reviewers. “I was blown away by the
Biologics
Moderna Phase 3 research found that its investigational mRNA-1083 combination flu and Covid-19 vaccine demonstrated noninferiority and induced higher immune responses than the recommended standard of care flu and Covid-19 vaccines in adults aged 50 and older. The company reported its research in the Journal of the
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FDA is announcing a 5/22 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations on the selection of the 2025-2026 formula for Covid-19 vaccines for use in the U.S. The meeting should shed some light on how FDA intends to regulate Covid-
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FDA commissioner Martin Makary told the 5/6 American Hospital Association annual meeting that the agency is encouraging companies seeking approval for Covid-19 vaccine booster shots to use “gold standard science,” including clinical trials involving healthy people. In an online post on Makary’s presentation, Health Day says the
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FDA has issued ImmunityBio a refusal to file letter for its recent supplemental BLA submission seeking approval for Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guerin (BCG) for treating papillary disease in non-muscle invasive bladder cancer (NMIBC) patients. Papillary diseases are characterized by tumors with a papillary growth
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FDA will soon require all new vaccines be evaluated in placebo-controlled trials before they’re licensed for use, and this could also apply to some seasonal vaccines for the flu and Covid-19, which are tweaked each year to provide protection against strains circulating around the world. “Under HHS
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FDA commissioner Marty Makary continues to suggest that the bar is moving for Covid-19 vaccine boosters, telling CBS News in a 4/29 interview that the last study Novavax had conducted to demonstrate clinical benefit was from 2021 “and it excluded people with prior Covid infection. Now, essentially everyone
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FDA commissioner Martin Makary says there will be no agency-wide reorganization. Interviewed by Jeremy Faust for an Inside Medicine Substack post, Makary said some staff asked for a reorganization and he rejected the proposal. “We are consolidating travel office, information technology, and some other things that make sense for
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FDA has approved Abeona Therapeutics’ Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, an autologous cell-based gene therapy for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB), a debilitating genetic skin disease. The BLA resubmission was filed 11/2024 following a 4/2024 complete response
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A Memorial Sloan Kettering Cancer Center clinical trial has demonstrated that immunotherapy alone can allow people with MMRd (mismatch repair deficiency) cancers to avoid surgery and preserve their quality of life, according to a cancer center statement. The statement says the Phase 2 trial showed that 80% of patients with
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Novavax and HHS are having to clarify that FDA is requesting a post-approval study and not a clinical trial that must be conducted prior to approval of the company’s Covid-19 vaccine, which is currently available under an emergency use authorization(EUA). The company’s pending BLA is