Biologics
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
Biologics
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
Biologics
FDA has approved a total of 73 biosimilars across 19 unique biological molecules, but so far only 48 (66%) of these have been launched in the U.S. market, according to a new Samsung Bioepis’ biosimilar market report. On average, biosimilars have gained 52% market share within five years post
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Novavax says its Covid-19 vaccine BLA, which the company is seeking to transition from an emergency use authorization to full approval, is being held up while FDA seeks to conclude a post-marketing commitment from the company. The agency had initially set a user fee-related review action target
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FDA has granted interchangeable biosimilar status to Celltrion’s Yuflyma (adalimumab-aaty), a high-concentration, citrate-free biosimilar copy of AbbVie’s Humira. The designation permits pharmacists to substitute Yuflyma for Humira without requiring a new prescription from a healthcare provider. The original Yuflyma BLA was approved 5/2023 for
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Former CBER director Peter Marks, who recently resigned due to pressure from the Trump administration over vaccines, told Time in a 4/8 interview that he was seeing “an increasing anti-vaccine tone” before he left. “I was hoping to work through it, but it was very clear to me
Biologics
FDA has granted Arcturus Therapeutics a fast-track designation for the self-amplifying mRNA (sa-mRNA) vaccine candidate, ARCT-2304, for protecting against disease caused by influenza A H5N1. The vaccine, which is formulated with Arcturus’ proprietary LUNAR delivery technology, is designed to make many copies of mRNA within the
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FDA has accepted for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD), a serious eye condition where abnormal blood vessels grow under the retina, potentially leaking blood or fluid and causing rapid
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FDA has granted Allogene Therapeutics three fast track designations for ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T cell therapy. The designations are for treating adults with: * active refractory moderate-to-severe systemic lupus erythematous (SLE); * active severe/refractory idiopathic inflammatory myopathy (IIM), specifically dermatomyositis, immune mediated
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One day before his forced resignation took effect 4/5, CBER director Peter Marks alleged in an exclusive interview with the Wall Street Journal that HHS secretary Robert F. Kennedy Jr. not only sought generation of new FDA data to support his antivaccine narratives but also reduction of regulatory safeguards
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Novavax says FDA has missed its 4/1 user fee review action target date on a BLA seeking full approval for its current Covid-19 vaccine, which is currently marketed under an emergency use authorization (EUA). “As of Tuesday, 4/1, we had responded to all of the FDA’s
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Analysis by Jim Dickinson] CBER director Peter Marks’ shocking resignation 3/28 raises an unexpected challenge to HHS secretary and vaccine skeptic Robert F. Kennedy Jr.’s fitness for office, for coercing it amid the morale-destroying consequences that President Trump’s mass firings are generating inside the agency and
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In a move that may assuage vaccine makers regarding HHS’s potential interference in vaccine reviews and approvals, Bavarian Nordic just gained FDA approval 3/31 for its freeze-dried formulation of Jynneos (smallpox and mpox vaccine, live, non-replicating) for preventing smallpox and mpox [monkeypox] disease in adults 18
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The Autism Self-Advocacy Network (ASAN) is blasting HHS and secretary Robert F. Kennedy, Jr., for hiring “known conspiracy theorist and quack David Geier to run a planned study which will investigate the thoroughly disproven idea of a link between childhood vaccinations and autism.” In a statement, ASAN says that
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Johnson & Johnson says data from its Phase 3 MARIPOSA study, a head-to-head study comparing the company’s Rybrevant (amivantamab-vmjw) versus AstraZeneca’s Tagrisso (osimertinib), showed that Rybrevant plus Janssen’s Lazcluze (lazertinib) outperformed Tagrisso by a three-to-one margin, significantly extending overall survival (OS) in
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CBER director Peter Marks says that in an ideal world vaccine clinical trial designs should evaluate the investigational vaccine’s effect on disease transmission. Having such data, particularly if the vaccine has a decent effect against transmission, would be beneficial in today’s age of growing vaccine hesitancy after the