Biologics
FDA has extended by three months its review of a GSK BLA for Blenrep (belantamab mafodotin) combinations for treating patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The new user fee review action target date is 10/23, which is intended
Biologics
An 8/23-8/31/2023 FDA inspection at the O3UV facility in Grand Ledge, MI, documented multiple violations in the firm’s illegal manufacturing of autohemotherapy devices. A 7/7 Warning Letter says the firm’s products are adulterated because the company does not have an approved PMA or
Biologics
FDA has rejected a Replimune priority-reviewed BLA for its melanoma therapy RP1 (vusolimogene oderparepvec). In a just-issued complete response letter, the agency said it could not approve RP1 in combination with nivolumab due to concerns about the clinical trial data. According to Replimune, FDA found the pivotal IGNYTE
Biologics
FDA has won its regulatory battle (see earlier story) against gene therapy maker Sarepta Therapeutics. Late last evening (7/21) the company announced that it will agree to FDA’s request to pause all shipments of Elevidys (delandistrogene moxeparvovec) for Duchenne muscular dystrophy in the U.S. “This proactive step
Biologics
Laura Loomer, a far-right influencer and conspiracy theorist, has it out for CBER director Vinay Prasad. Loomer, who often has president Trump’s ear and influenced the ouster of a number of “disloyal” Trump officials and aides, now has her sights on Prasad, who she says should be removed
Biologics
An HHS official tells FDA Webview the agency is taking a "hard look" at pulling from the market Sarepta Therapeutics’ Elevidys (delandistrogene moxeparvovec-rokl), an adeno-associated virus vector-based gene therapy for treating Duchenne muscular dystrophy patients. The move is in response to two reports of fatal
Biologics
CBER director Vinay Prasad has again overridden medical reviewers to limit a Covid vaccine’s use, according to a just-posted “decisional memo.” The latest incident involves the agency’s 7/9 approval of Moderna’s sBLA for Spikevax, the company’s Covid-19 vaccine, in children aged six months
Biologics
FDA is currently conducting benefit-risk modeling studies based on the evolving risk of Covid-19 severe outcomes and the long-term cardiac damage from vaccine-associated myocarditis, agency leaders say in a new JAMA article that outlines their rationale in ordering recent safety labeling change to mRNA Covid vaccines.
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
Biologics
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
Biologics
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-
Biologics
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
Biologics
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