The FDA has issued a warning letter to Green Wave Analytical for denying the agency’s investigators access to the contract testing laboratory’s San Diego, Calif., facility for the first three…
Amgen’s oral chemotherapy sotorasib significantly improved progression-free survival relative to intravenous docetaxel in patients with previously treated KRAS G12C-mutated nonsmall-cell lung cancer (NSCLC) in a late-stage study. Source: Drug Industry…
Novo Nordisk’s Wegovy (semaglutide) was superior when compared to several other weight loss drugs for therapeutic effect, but at an annual cost of $7,500 to $9,800 would require a discount…
In the midst of a pandemic, if you wait for all the data to come in, “you’ve missed the boat,” said FDA Commissioner Robert Califf yesterday regarding the agency authorizing…
Inadequate procedures to minimize the risk of contamination earned Lupin Limited a Form 483 following a March 22 to April 4 FDA inspection of its facility in Palghar, Maharashtra, India.…
Neurocrine Biosciences has made a bid for the UK-based Diurnal Group, a move that could pull in a phase 3 candidate for treating congenital adrenal hyperplasia (CAH). Source: Drug Industry…
The University of Michigan and University of South Florida are suing Novartis for patent infringement, claiming that the pharma giant used a complex method of crystal engineering developed by their…
A new study of cancer drugs awarded FDA accelerated approval debunks the theory that drugmakers benefit financially from postmarket confirmatory trials that support the approval. Source: Drug Industry Daily
Westwood Laboratories’ Azusa, Calif., contract manufacturing facility lacks adequate sterility procedures, according to a Form 483 issued following a March 24 to April 5 inspection. Source: Drug Industry Daily
FDA’s draft guidance on mitigating drug shortages is inconsistent with the law, would place an unnecessary weight on drug manufacturers and could make drug shortages worse, according to industry stakeholders’…