Archive for August 2022

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 days of its inspection and for inadequate testing methods and record-keeping failures. Source: Drug Industry Daily

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 Daily

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 from the wholesale acquisition cost of 44 to 57 percent to make it cost effective. Source: Drug Industry Daily

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 both Pfizer/BioNTech’s and Moderna’s bivalent COVID-19 boosters before any clinical trials on them are complete. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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 Daily

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 researchers to design the heart failure drug Entresto, a combination of sacubitril and valsartan. Source: Drug Industry Daily

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FDA’s draft guidance on mitigating drug shortages is inconsistent with the law, would place an unnecessary weight on drug manufacturers and could make drug shortages worse,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’ comments. Source: Drug Industry Daily