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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. Read More
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. Read More
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. Read More
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. Read More
FDA’s draft guidance on mitigating drug shortages is inconsistent with the law, would place an unnecessary weight on drug manufacturers and could make drug shortages worse,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. Read More
Silbersher can still argue that he is the original source of the public information and that his case against AbbVie should be allowed to proceed. Read More
The FDA endorsed a number of International Council for Harmonization (ICH) guidelines last week, issuing three draft guidances and one final guidance in support of the council’s recommendations on drug interaction studies, analytical procedure development/validation and clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential. Read More
Moderna announced Friday it is filing patent infringement lawsuits against Pfizer and BioNTech for allegedly infringing on the messenger RNA (mRNA) technology it developed for its COVID-19 vaccine, Spikevax. Read More
The White House’s Office of Science and Technology Policy has issued a memo directing federal agencies with R&D spending to publicly share the findings and data from government-funded research as soon as they’re published, a move that should expand the amount of data available to researchers outside of the government. Read More