September 2008 Issues

European Association for the Study of Diabetes

Summary: New drugs recently approved and in development were a hot topic at EASD. ♦ DPP-4s: Data mounted on the safety and efficacy of two DPP-4 inhibitors – Merck’s Januvia, Novartis’s Galvus – but questions were raised about hypertension with Bristol- Myers Squibb’s Onglyza, and efficacy was unimpressive with Takeda’s alogliptin. ♦ GLP-1s: The data on Novo Nordisk’s liraglutide was very good, but positing vs. Lilly/Amylin’s Byetta and once-weekly exenatide will be key. Doctors are watching the pancreatitis with Byetta but are not too concerned – yet. ♦ Insulin: The data on Biodel’s Viaject insulin were controversial, and a study found continuous glucose monitors (CGMs) effective only in adults age ≥25. ♦ Obesity: Diabetes doctors feel this is now back in their realm, and they are waiting for more data on several drugs. ♦ SGLT2 inhibitors: Bristol-Myers Squibb and AstraZeneca have an education hurdle with dapagliflozin.

American Society for Bone and Mineral Research (ASBMR) -- Quick Pulse

Summary: The key topic at this meeting was Amgen’s denosumab for osteoporosis, but there were also interesting data on parathyroid hormone (PTH) secretagogues – particularly Novartis’s ATF-936 and GlaxoSmithKline/NPS Pharmaceuticals’ ronacaleret – as well as cathepsin K inhibitors such as Merck’s odanacatib.   

FDA Bars More than 30 Generic Drugs Made by Ranbaxy Laboratories in India -- Quick Pulse

Summary: The FDA has banned more than 30 generic drugs made by India-based Ranbaxy Laboratories because of manufacturing violations at two of its plants in Dewas and Paonta Sahib (including the Batamandi unit), India . The FDA also issued two Warning Letters to the drugmaker, which is one of the largest foreign suppliers of generic drugs to the U.S.