Biologics
FDA is announcing a 9/19 scientific workshop to discuss the development of interchangeable biosimilar products to help identify future needs (e.g., guidance, research). The agency says the meeting agenda includes presentations by representatives from the biosimilar industry on the future needs for the development of interchangeable products, discussions
Biologics
FDA has approved a Moderna sBLA for Spikevax, the company’s Covid-19 vaccine, in children aged six months through 11 years who are at increased risk for Covid-19 disease. A company statement says the FDA full approval replaces the previous emergency use authorization.
Biologics
Former FDA commissioner Scott Gottlieb says that under HHS secretary Robert F. Kennedy, Jr., the change to the membership of the CDC Advisory Committee on Immunization Practices (ACIP) “does look like a political process right now.” Gottlieb commented on the 6/29 CBS News program “Face the Nation.” “I think
Biologics
Moderna says its mRNA-1010 investigational seasonal flu vaccine achieved the most stringent superiority criterion prespecified in a Phase 3 efficacy trial that tested it against a licensed standard-dose influenza vaccine in adults aged 50 and older. A company statement says that in a previous Phase 3 study, the
Biologics
A 1/28-2/5 FDA inspection at InVia Fertility Specialists in Hoffman Estates, IL, documents significant violations of the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). A just-released 6/13 Warning Letter says the specific violations were: * failure to test a specimen
Biologics
A group of medical societies has filed suit against HHS secretary Robert F. Kennedy Jr. and FDA commissioner Marty Makary to reverse a 5/27 decision (see earlier story) to revoke Covid-19 vaccine recommendations for children and pregnant people. The lawsuit was filed in the U.S. District Court
Biologics
Former CBER director Peter Marks says the FDA announcement of a new “evidence-based approach to Covid-19 vaccination” is a “dramatic departure” not just from previous agency vaccine policies but also from the deliberate and measured way in which the agency previously made such policy, with open public discussion
Biologics
FDA has required and approved updates to the prescribing information for Pfizer’s Comirnaty Covid-19 mRNA vaccine and Moderna’s Spikevax Covid-19 mRNA vaccine to include new safety information about the risks of myocarditis and pericarditis following their administration. The warning on myocarditis and pericarditis in the vaccines’
Biologics
FDA has told Capricor Therapeutics that its ongoing BLA review of Deramiocel, the company’s lead cell therapy candidate for treating Duchenne Muscular Dystrophy (DMD)-associated cardiomyopathy, has not necessitated an advisory committee meeting before its user fee review action target date of 8/31. “We remain confident in the
Biologics
FDA says it is halting and will review new clinical trials that involve sending American citizens’ living cells to “China and other hostile countries for genetic engineering and subsequent infusion back into U.S. patients, sometimes without their knowledge or consent.” An agency statement says it took action due to
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CBER Office of Therapeutic Products director Nicole Verdun and her deputy Rachael Anatol, have been pushed out of the Center and placed on administrative leave in the latest shake-up at FDA. An HHS spokesperson hinted that the move was orchestrated by CBER director Vinay Prasad, telling FDA Webview that
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Former FDA commissioner Scott Gottlieb expects FDA will reevaluate Sarepta’s approval of Duchenne muscular dystrophy (DMD) gene therapy Elevidys based on two recent patient deaths (see story) and the past controversial nature of former CBER head Peter Marks review interference in 2024 (see earlier story). Marks overrode his then-
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Rep. Frank Pallone (D-NJ), the top Democrat on the House Energy and Commerce Committee, is calling on the committee to open a bipartisan investigation into HHS secretary Robert F. Kennedy, Jr.’s “recent efforts to disrupt and restrict people’s access to vaccines.” In a letter to committee chairman
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CBER director Vinay Prasad has been given additional duties as FDA’s chief medical and scientific officer, a new combination role for commissioner Marty Makary’s closest advisor. “In this capacity, he will serve as a trusted advisor to the FDA commissioner and other senior officials on cross-cutting and
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
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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
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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
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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
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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
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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
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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