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The FDA’s Office of Pharmaceutical Quality is developing a new inspection protocol that will focus on expert investigator-developed questions and assessment practices. Read More
Teva is asking the U.S. Supreme Court to overturn a Pennsylvania state court ruling that would let individuals sue generics makers for failing to promptly update their labels in response to new safety concerns, a move some experts say directly contradicts federal statutes. Read More
Mylan has settled patent litigation related to Pfizer’s Viagra, paving the way for generic copies of the erectile dysfunction blockbuster in the U.S. in 19 months. Read More
The Medicines Company’s Kengreal may be on the road to approval, with FDA reviewers backing its use as a post-angioplasty anticlotting agent one year after the agency rejected the drug for this and another indication. Read More
A drug safety committee in the EU is recommending that manufacturers of ibuprofen be required to warn patients that taking the painkiller in high doses is associated with an increased risk of cardiovascular death. Read More
Japan’s drug authority will grant conditional approval to human embryonic and somatic stem cell therapies based on limited clinical data, under a new approval pathway meant to speed patient access to innovative products. Read More
Canadian biotech company Tekmira will restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, following the FDA’s downgrading of a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day. Read More
The FDA and Health Canada will meet May 15 in White Oak, Md., to discuss a wide range of international pharma guidelines — the first joint meeting since the agencies formed a Joint Regulatory Cooperation Council in 2011. Read More