Biopharmconsortium Blog

Expert commentary from Haberman Associates biotechnology and pharmaceutical consulting.

Monthly Archives: August 2010

Can the pharmaceutical/biotechnology industry develop better insulin sensitizers? A breakthrough result in the biochemistry of PPARγ

TweetIn part 1 of this three-part series (posted August 23, 2010), we discussed the recent action of the  Endocrinologic and Metabolic Drugs Advisory Committee regarding rosiglitazone (GlaxoSmithKline’s Avandia). The advisory committee, by a close vote, recommended to the FDA that it leave the drug on the market, with new restrictions (e.g., closer supervision and new…

Phase I trial of Roche/Plexxikon’s PLX4032, a selective targeted therapeutic for metastatic melanoma, published in the New England Journal of Medicine

TweetIn March 2010, we published two articles on this blog relating to Roche/Plexxikon’s PLX4032 for metastatic melanoma. The first article, dated March 2, described a Phase I clinical trial of the drug, based on an article about this trial in the New York Times (NYT). The second article, dated March 10, described Plexxikon’s discovery of…

Aileron Therapeutics partners with Roche

TweetOn November 27, 2009, we posted an article on this blog about the use of stapled peptides in targeting intracellular pathways. This technology was originally developed by Dr. Gregory Verdine (Department of Chemical Biology, Harvard University, Cambridge MA, and the Dana-Farber Cancer Institute, Boston MA) and his colleagues. A biotechnology company, Aileron Therapeutics (Cambridge, MA)…

Avandia squeaks through an FDA Advisory Panel. But can the pharmaceutical/biotechnology industry develop better insulin sensitizers?

TweetOn July 15, 2010, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted to leave the diabetes drug rosiglitazone  (GlaxoSmithKline’s  Avandia) on the market, with some new restrictions (e.g., closer supervision and new label warnings). This is the same committee that voted against FDA approval of Vivus’ anti-obesity drug Qnexa on the same day, as…

It’s still tough to get an antiobesity drug through the FDA

Tweet2010 was supposed to be the year in which one or more new obesity drugs would be approved by the FDA and reach the market. Three new drugs developed by small California companies–Vivus Pharmaceuticals’ Qnexa, Orexigen Therapeutics’ Contrave, and Arena Therapeutics’ lorcaserin, were up for review by the FDA. This follows a long hiatus, since…