BOSTON – Lawmakers reached agreement late Monday on PDUFA V. The House is expected to pass the legislation, S. 3187, Wednesday, followed by the Senate late this week or early next week, coming in well ahead of their self-imposed July 4 goal. Read More
Asking for a second efficacy study, the FDA issued a complete response letter (CRL) for Pfizer Inc.'s new drug application for tafamidis meglumine to treat the orphan indication of transthyretin familial amyloid polyneuropathy (TTR-FAP). Read More
BOSTON – Mind the gap. It's not enough to chart a regulatory pathway and see biosimilar products through to approval; there remain problems with promoting uptake and delivering the promised cost savings to payers, as experience in Europe illustrates. Read More
Despite widespread protests, including a visit from a delegation to its global headquarters in Darmstadt, Germany, and a one-day work stoppage last week, Merck KgaA is proceeding with its original plan to shutter the Geneva headquarters of its Merck Serono division and to transfer all R&D out of Switzerland. Read More
• Nuevolution A/S, of Copenhagen, Denmark, raised $13.7 million in a new financing round led by Industrifonden, with strong support by existing investors Sunstone Capital, SEB Venture Capital and SEB Utvecklingsstiftelse. Read More
WASHINGTON – Trying to increase the risks of making and peddling counterfeit drugs so they outweigh the potential financial gain, the House passed a bill Monday that puts drug counterfeiting on par with fake military products. Read More
In the biotechnology world, all eyes are on Boston and the BIO 2012 convention this week. But across the country, in San Francisco, the American Society for Microbiology is also having its annual meeting. And on Tuesday, a late-breaking session at that meeting reported the newest findings of the Human Microbiome Project. Read More
• Coronado Biosciences Inc., of Burlington, Mass., reported that the FDA granted orphan drug status to its biologic CNDO-109 for the treatment of acute myeloid leukemia (AML). Read More
• NewLink Genetics Corp., of Ames, Iowa, has passed the midpoint in enrollment in its Phase III hyperacute pancreas immunotherapy product candidate (algenpantucel-L) trial with full enrollment projected to be completed by the end of 2013. Read More
• Sanofi SA, of Paris, and the Joslin Diabetes Center, of Boston, reported that they have established a collaboration that will focus on four key areas within diabetes and related metabolic disorders to identify potential new biologics or small drug candidates for the treatment of late complications of diabetes and new insulin analogues with more targeted efficacy. Read More
• Pfizer Inc., of New York, said its ALK inhibitor Xalkori (crizotinib) met its primary endpoint in the PROFILE 1007 study, demonstrating significantly improved progression-free survival (PFS) when compared with pemetrexed or docetaxel, in previously treated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC). Read More
