Amgen Inc. posted higher-than-expected third quarter earnings, thanks in large part to a hefty one-time government purchase of Neupogen (filgrastim). That contract, combined with anticipated revenues from recently acquired Onyx Pharmaceuticals Inc., prompted the Thousand Oaks, Calif.-based biotech to bump up its revenue guidance for the year but fell short of distracting investors and analysts away from long-term plans for growth. Read More
Shares in Basilea Pharmaceutica AG rose more than 7 percent Wednesday on news that its broad spectrum cephalosporin antibiotic ceftobiprole gained approval in Europe for treating hospital- and community-acquired pneumonia in adults. The company is still on the hunt for a commercialization partner, however, and the drug will not reach the market until next year. Read More
FDA briefing documents appear to be positive in advance of a meeting of the FDA Antiviral Drugs Advisory Committee scheduled for Friday to discuss approval of sofosbuvir in hepatitis C virus (HCV). Questions for the panelists focus on optimal duration of therapy in genotype 2 and 3 patients. The FDA’s documents suggest that the agency is favorably inclined toward approval of the drug, and sees no significant safety issues with it. Read More
The question is no longer should clinical trial data be shared but, rather, how can it best be shared. Hoping to answer that question, an Institute of Medicine (IOM) committee heard from a range of experts Wednesday on strategies to responsibly share raw trial data. Read More
Scientists have identified a key signaling molecule that the liver uses to influence muscle metabolism, and shown that such signaling has its own circadian rhythms. Read More
• Lorus Therapeutics Inc., of Toronto, said that it has received court approval to delay its Annual General Meeting to a date no later than March 31, 2013. Read More
• Ziopharm Oncology Inc., of Boston, said it intends to commence an underwritten public offering of $50 million shares of its common stock. J.P. Morgan Securities LLC will act as sole book-running manager for the proposed offering and the company intends to grant the underwriters a 30-day option to purchase up to $7.5 million of additional shares. Read More
• Halozyme Therapeutics Inc., of San Diego, Calif., began a Phase Ib/II trial of PEGPH20 in combination with FOLFIRINOX chemotherapy compared to FOLFIRINOX alone in metastatic pancreatic adenocarcinoma. The trial will enroll about 144 patients. The initial Phase Ib portion of the trial will confirm the optimal dose of PEGPH20 for the Phase II potion, which will evaluate overall survival. Secondary endpoints include progression-free survival, objective tumor response, and adverse events. Read More
• Merck & Co. Inc., of Whitehouse Station, N.J., said the FDA granted MK-5172/MK-8742 breakthrough therapy designation for treatment of chronic hepatitis C virus infection. MK-5172/MK-8742 is an all-oral combination regimen consisting of MK-5172, an investigational HCV NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor. Interim data from an ongoing Phase IIb clinical trial evaluating MK-5172/MK-8742 in genotype 1 infected patients (C-WORTHY Study) is scheduled to be presented at the 64th American Association for the Study of Liver Disease Annual Meeting in November. Read More
