Biologics
FDA has scheduled a 7/17 meeting of its Oncologic Drugs Advisory Committee to review and vote on a GSK BLA for Blenrep (belantamab mafodotin) for treating adults with multiple myeloma in combination with bortezomib and dexamethasone in patients who have received at least one prior line of therapy; and
Biologics
Questions are being raised about some of the eight people HHS secretary Robert F. Kennedy, Jr., has appointed to the CDC Advisory Committee on Immunization Practices (ACIP). The appointments were made after Kennedy “retired” all 17 of the current members, the Associated Press reports, raising concerns among public health experts
Biologics
FDA’s full approval last month of Novavax’s Covid-19 vaccine is raising alarms due to its unusual delay and politically entangled review process that diverged from long-established regulatory norms, according to former agency and HHS officials writing in a 6/9 JAMA viewpoint article. The vaccine had
Biologics
In a contentious interview on CBS’s Face the Nation 6/1, FDA commissioner Marty Makary struggled to sort out and clarify the federal government’s shifting stance on Covid-19 vaccinations for healthy children and pregnant women — stressing a move away from universal recommendations and toward individualized, doctor-guided
Biologics
CBER director Vinay Prasad is embracing both surrogate endpoints for accelerated approval and overall survival data in confirmatory studies for rare disease products. Speaking at the 6/3 National Organization for Rare Disorders’ (NORD) Rare Disease Scientific Symposium, Prasad reassured companies, researchers and patients that FDA “will take action at
Biologics
FDA has approved a Moderna BLA for mNexspike (mRNA-1283), the company’s next-generation vaccine against Covid-19 for use in all adults 65 and older, and individuals aged 12-64 years with at least one or more underlying risk factor as defined by the CDC. The company notes
Biologics
HHS has terminated a $590 million late-stage grant award to Moderna and its development of a vaccine candidate targeting the H5 avian influenza virus subtype. The termination news comes as the company announces “positive interim data” from a Phase 1/2 clinical study (NCT05972174) evaluating the safety and immunogenicity
Biologics
Eight congressional Democrats who were members of the Select Subcommittee on the Coronavirus Pandemic say they are deeply concerned about the FDA decision to limit the approval of updated Covid-19 vaccines. “We find it perplexing that this new guidance undermines the foundational principles of Operation Warp Speed, a program
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
Biologics
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
Biologics
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
Biologics
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
Biologics
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
Biologics
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
Biologics
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
Biologics
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
Biologics
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-