As anticipated, the FDA issued a complete response letter for Taltorvic (ridaforolimus) from Merck & Co. Inc. and Ariad Pharmaceuticals Inc. as a maintenance therapy for metastatic sarcoma. Read More
WASHINGTON – Whether a biosimilar by any other name would be prescribed as readily as the brand biologic it mimics is the budding debate as the FDA moves forward on the biosimilar pathway. Read More
After a relatively tough year for stem cell companies on the public markets, they finally had something to cheer about – a regulatory milestone that could pave the way for a number of future approvals of stem cell therapies currently in late-stage clinical trials. Read More
• Sernova Corp., of London, Ontario, received gross proceeds of C$772, 182 (US$750,508) by exercising 3.9 million common share purchase warrants, which were issued in connection with private placements that closed between 2009 and 2011. Read More
• Enamine Ltd., of Kiev, Ukraine, signed a collaboration agreement with the Medical Research Council Laboratory of Molecular Biology (MRC LMB) in Cambridge, UK, and the Institute of Organic Chemistry and Biochemistry of the Academy of Sciences of the Czech Republic (IOCB) in Prague, Czech Republic, to discover rhomboid protease inhibitors as potential drugs to treat infectious, parasitic, oncological, immune and cardiovascular diseases. Read More
• Hyperion Therapeutics Inc., of South San Francisco, said a 178-patient Phase II study of glycerol phenylbutyrate, a pre-prodrug of phenylacetic acid, in episodic hepatic encephalopathy (HE) met its primary endpoint. Read More
• Merck Serono SA, of Geneva, said it is taking its first step into the biosimilar space through a partnership with Dr. Reddy's Laboratories Ltd., of Hyderabad, India. The partnership will focus on co-developing a portfolio of biosimilar cancer compounds, most of which will be monoclonal antibodies. The agreement, based on full R&D cost-sharing, covers co-development, manufacturing and commercialization of the compounds. Read More
• Bristol-Myers Squibb Co., of New York, said the AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïve rheumatoid arthritis Subjects With Background Methotrexate) study met its primary endpoint, as measured by noninferiority, and demonstrated that Orencia (abatacept) plus methotrexate achieved comparable rates of efficacy to Humiara (adalimumab, Abbott) for the American College of Rheumatology criteria of 20 percent response at one year (63.4 percent vs. 64.8 percent). Read More
• Hutchison MediPharma Ltd., of London, reported Phase I data showing sulfatinib (HMPL-012), a small-molecule inhibitor of vascular endothelial growth factor (VEGF) and fibroblast growth factor receptors, was well tolerated at doses up to 300 mg per day or 150 mg twice daily and demonstrated preliminary antitumor activity in multiple cancer types, including liver cancer. Read More
• Janssen Research & Development LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson, reported data from the Phase III PHOENIX study showing that maintenance treatment with Stelara (ustekinumab) for up to five years resulted in consistent, significant clinical response in adults with moderate to severe plaque psoriasis. Read More
