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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
Baxter International issued its sixth recall of intravenous solutions since December 2013, recalling 15 lots — about 237,000 units — because of the potential presence of particulate matter. Read More
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet Tuesday to review the safety of DPP4 inhibitors, a class of diabetes drug the FDA first approved in 2009. Read More
The FDA has granted Shire’s dry eye treatment lifitegrast a priority review, cutting its NDA review time to six months rather than the usual 10 months. Read More
Drugmakers making major alterations to their products will require a different EU number if they change the specifications or the amount of units contained in a pack, under updated guidelines in Europe. Read More
Australia’s Therapeutic Goods Administration is turning to the European Union for guidance as it seeks to adopt 10 guidelines — four new and six replacements — to improve the nation’s drug system. Read More
A federal judge has ordered the FDA to turn over all records concerning Otsuka’s Abilify sNDA to the U.S. district court in Maryland by Monday, saying the agency is attempting to delay litigation over exclusivity of the blockbuster antipsychotic. Read More
The Federal Trade Commission Wednesday approved Novartis’ divestiture of its targeted cancer drug business, clearing the way for a portfolio swap with GlaxoSmithKline valued at $21 billion. Read More
Novo Nordisk is moving forward two years after the FDA rejected two insulin therapies, with the agency’s agreement to review Class II resubmissions of its NDAs for Tresiba and Ryzodeg drugs based on an interim analysis of data from a cardiovascular outcomes study. Read More