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Over the past week, the FDA issued a draft guidance on product-specific guidances, extended the comment period on a draft guidance for human cellular and gene therapy products, published a list of bulk drugs for which there is a clinical need under section 503B of the FD&C Act and notices of advisory committee meetings for oncologic drugs, endocrinologic and metabolic drugs and vaccines and related biological products. Read More
HHS announced a slate of new funding initiatives this week, including $1.4 billion for Project NextGen to support development of novel COVID-19 technologies and $24 million for Curing the Uncurable via RNA-Encoded Immunogene Tuning (CUREIT), part of the Biden administration’s Cancer Moonshot program. Read More
This European Edition of Quick Notes includes a Swissmedic study of drug approval times, $16 million awarded by UK Innovate, an announcement by Roche of phase 3 anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) preliminary results and an Access to Medicine Foundation report on antimicrobial resistance and responsible manufacturing. Read More
This month, FDAnews tackles studies for two promising obesity drugs, a first-of-its-kind pneumococcal vaccine for adults and a partial clinical hold for a blood cancer drug. Read More
Apellis Pharmaceuticals’ safety probe into reports of retinal vasculitis linked to its eye drug-device combo Syfovre (pegcetacoplan) has discovered that the culprit is likely the company’s injection kits, not the therapy itself. Read More
In a brief filed Monday, Amgen and Horizon argue that the U.S. District Court of Northern Illinois shouldn’t let the Federal Trade Commission (FTC) block their union over concerns that a dangerous monopoly on two blockbuster drugs will result. Read More
Intarcia Therapeutics will continue its seven-year quest for FDA approval of its drug-device diabetes treatment with an alternative form of hearing — a public hearing before an advisory committee on Sept. 21to discuss CDER’s refusal to approve the product. Read More
Upcoming events in the coming weeks include seven FDA advisory committee meetings as well as the the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, and webinars from FDAnews, a WCG company on medical device risk management tools and calculating sample sizes for verification and validation activities. Read More
Should the FDA get the 11 percent increase in funding that it’s gunning for from Congress, a large chunk will be spent improving internal data quality at the agency, said FDA Commissioner Robert Califf on Tuesday. Read More