The U.S. FDA’s efficacy bar for COVID-19 vaccines for the youngest children may be lower than the 50% required for the adult vaccines, according to Peter Marks, director of the agency’s Center for Biologics Evaluation and Research.<
In a draft guidance released May 9, the U.S. FDA described the benefit-risk principles it uses when conducting quality-related assessments of chemistry, manufacturing and controls (CMC) information submitted as part of a new drug application, biologics license application or supplement.
A risk of rare but potentially life-threatening blood clots in combination with low platelet levels after a jab of Johnson & Johnson's Janssen COVID-19 vaccine has convinced the U.S. FDA to limit its use. The vaccine is now authorized in the U.S. only for adults who wouldn't otherwise be vaccinated and those who can't or shouldn't, for medical reasons, get another approved vaccine. Through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases of the condition, called thrombosis with thrombocytopenia syndrome – a rate of 3.23 cases per million doses of vaccine administered.
Orphalan SA is laying the ground for a 2023 U.S. launch of Cuvrior for the treatment of Wilson’s disease, following FDA approval of the copper chelating drug. Cuvrior (trientine tetrahydrochloride) is a new salt of trientine that was designed to have superior properties to Syprine (trientine hydrochloride) from Bausch Health Companies Inc. and Cufence from Univar Solutions BV, which are approved as second-line treatments for the rare inherited copper transport disorder, in the U.S. and EU respectively.
The latest in a spate of draft and final guidances released recently by the U.S. FDA could help sponsors developing drugs to treat early stage solid tumor malignancies.
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
Bristol Myers Squibb Co.’s audacious $13.1 billion 2020 takeover of Myokardia Inc. appears to have paid off with U.S. FDA approval of the drug at the heart of the deal, mavacamten. The medicine, a cardiac myosin inhibitor for treating adults with obstructive hypertrophic cardiomyopathy (HCM), will be marketed under the brand name Camzyos.
In his second stint as U.S. FDA commissioner, Robert Califf discussed the challenges in leading a massive agency that has seen seven commissioners come and go over the past 10 years.
Mycovia Pharmaceuticals Inc. is prepping to launch its first commercial product following U.S. FDA approval of oral antifungal oteseconazole for use in recurrent vulvovaginal candidiasis (RVVC). Branded Vivjoa, the drug is expected to be available to patients during the second quarter.
In the second of two hearings before the U.S. Senate Health, Education, Labor and Pensions Committee on the next iteration of the FDA drug and device user fee agreements, the focus was supposed to be on advancing regulation and innovation. But Ranking Member Richard Burr (R-N.C.) shifted the spotlight April 26 to accountability in his opening remarks and subsequent questioning.
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