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The FDA plans to clear up questions about the types of off-label information drugmakers may communicate to physicians and payers in a series of guidances planned for later this year that will address four key areas that have long tripped up industry. Read More
Teva cleared a major hurdle last week in its bid to launch a generic version of Bristol-Myers Squibb’s hepatitis B drug Baraclude after a federal appellate court upheld a lower court’s decision invalidating the drug’s patent. Read More
British authorities continue to investigate 21 cases of blood poisoning in babies who received potentially contaminated batches of an intravenous liquid feed at neonatal intensive care units in England, but said the manufacturer of the product was following good manufacturing practice guidelines. Read More
A federal appeals court needs to rethink its definition of “a patient” or risk upholding a dangerous precedent in future Hatch-Waxman cases after a recent patent ruling on the colon cleanser Suprep, trade groups BIO and PhRMA argue in a joint legal brief. Read More
A Massachusetts insurer filed a lawsuit this week against Takeda and Eli Lilly in the U.S. District Court for the Western District of Louisiana for allegedly hiding cancer risks of its type 2 diabetes drug Actos. Read More
The FDA chided Citius Pharmaceuticals for a webpage promoting its product Suprenza that omits risk information and makes overblown claims about the weight loss drug. Read More
Companies throughout the drug supply chain that encounter suspected counterfeit products should file a report with the FDA and any affected trading partner within 24 hours, the agency said. Read More