Buoyed by ever-faster sequencing abilities, scientists are making headway in understanding cancer genomics. But, William Sellers told the audience at the American Association of Cancer Research meeting this week, as impressive as genomic advances have been, "most known genetic alterations have not led directly to drug candidates." Read More
Following the lead of Verastem Inc., which raised $55 million earlier this year in its initial public offering (IPO), New York-based Stemline Therapeutics Inc. filed an S-1 registration statement with the SEC for an IPO, seeking $50 million to advance its cancer stem cell therapeutics. Read More
Nearly eclipsed by the lengthy approval process for Bydureon (exenatide once-weekly), Amylin Pharmaceuticals Inc.'s metreleptin (recombinant methionyl human leptin) in diabetes lipodystrophy may soon get its moment in the sun. Read More
• Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said the FDA extended the PDUFA date for Lymphoseek (99m-Tc-Tilmanocept) by 90 days, to Sept. 10, after the company provided updated chemistry, manufacturing and control information requested by the agency within the 90-day period prior to the original PDUFA date. Lymphoseek is a radioactive tracing agent for lymphatic mapping and lymphoscintigraphy. Read More
• Human Genome Sciences Inc., of Rockville, Md., said partner GlaxoSmithKline plc, of London, announced top-line results from seven of eight Phase III (Harmony) trials of albiglutide for Type II diabetes showing positive results. Harmony 6 compared albiglutide to preprandial insulin, finding clinically significant reductions in HbA1c. Harmony 7 results, comparing albiglutide to once-a-day liraglutide, were announced in November 2011. For ongoing Harmony 1 through 5 trials, early study data showed results consistent with the two completed studies. Read More
• Valeant Pharmaceuticals International Inc., of Mississauga, Ontario, said it will relocate its global headquarters and establish a new R&D center for dermatology in Laval, Quebec. The Quebec government is supporting the move, which will make Valeant the only multinational pharmaceutical company with headquarters in Quebec. Read More
• Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., a subsidiary of Bayer AG, said its Phase III GRID (GIST – Regorafenib in Progressive Disease) trial evaluating investigational compound regorafenib (BAY 73-4506) in patients with progressive metastatic and/or unresectable gastrointestinal stromal tumors (GIST) met its primary endpoint of statistically significant improvement in progression-free survival. Read More
