In a watershed decision, a federal appeals court declares that manufacturers cannot be prosecuted under the FD&C Act’s misbranding provisions solely for speech promoting off-label use of a drug. Industry attorneys predict the decision, if it stands, will change the government’s approach to pursuing such cases.
A landmark appeals court ruling that the government cannot prosecute pharmaceutical manufacturers under the Food, Drug & Cosmetics Act (FD&C) Act’s misbranding provisions solely for off-label promotion likely will reshape the FDA and Justice Department’s approach to bringing such actions but will not foreclose them, industry attorneys say.
In a 2-1 opinion issued December 3, a panel of the Second Circuit US Court of Appeals said...
Aneesh Karatt-Vellatt is leading the charge to redefine how ion channels and G protein-coupled receptors (GPCRs) are targeted with antibody therapies, one of the most notoriously challenging classes of drug targets.
In the latest podcast interview, Phil L'Huillier, CEO of Scancell, discussed the company's work in cancer vaccine development, and its selection as the first British biotech to be a part of the NHS Cancer Vaccine Launch Pad.
New report by global law firm Taylor Wessing and Bayes Business School forecasts a steadily increasing volume of major life sciences M&A in the coming five years, but highlights concerns over cybersecurity and unrealistic valuations. Taylor Wessing partner Andrew Edge spoke to In Vivo.
