The FDA slapped a clinical hold on Achillion Pharmaceuticals Inc.'s hepatitis C virus (HCV) drug sovaprevir after elevations in liver enzymes turned up in a Phase I trial, though the agency will allow continued enrollment and treatment of patients in the ongoing Phase II trial of sovaprevir with ACH-3102 and ribavirin for treatment-naive genotype 1 HCV. Read More
Another set of positive Phase III data with oritavancin, a semi-synthetic lipoglycopeptide antibiotic, in acute bacterial skin and skin structure infections (ABSSSIs) puts The Medicines Co. in line for a 2014 approval, and possibly a partnership to help commercialize the compound, which treats disorders caused by susceptible gram-positive bugs that include methicillin-resistant Staphylococcus aureus (MRSA). Read More
The days of reading European tea leaves to predict the future for biosimilars in the U.S. may be coming to an end as the U.S. regulatory path for the follow-on biologics brews its own distinct flavor. Read More
• Mnemosyne Pharmaceuticals Inc., of Providence, R.I., increased its Series A financing with the addition of a new $6 million expansion round. The expansion round includes one new investor, Atlas Venture, and one existing investor, Clal Biotechnology Industries (CBI, previously Access Bridgegap Ventures). Peter Barrett, partner at Atlas, will join Mnemosyne's board, along with William Koster for CBI. Read More
• Bioinvent International AB, of Lund, Sweden, said it signed an extension to its 2009 license agreement with Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, for the development of antibodies from Bioinvents' n-CoDeR library. Under the terms of the extension, Mitsubishi Tanabe will continue to have access to Bioinvent's discovery and development technology platform for a further two years and can develop up to eight antibody programs. Read More
• Merck and Co. Inc., of Whitehouse Station, N.J., said the FDA approved new labeling for Isentress (raltegravir), including 240-week results from the STARTMRK study, a double-blind, Phase III noninferiority trial evaluating an integrase inhibitor for treatment-naive adults patients with HIV-1 infection. Read More
• CSL Behring, of King of Prussia, Pa., reported pharmacokinetic results for its recombinant coagulation single-chain Factor VIII, showing improved half-life over comparator octocog alfa. Read More
• Immunomedics Inc., of Morris Plains, N.J., reported findings from a Phase Ib study with 90Y-clivatuzumab in patients with metastatic pancreatic cancer who had received at least two prior treatments. Read More
