DUBLIN – Shire plc is challenging Roche Holding AG’s imminent disruption of the hemophilia A market by slapping a preliminary injunction on the Swiss pharma, alleging that the latter’s description of adverse events that occurred in a phase III trial of emicizumab is “inaccurate and misleading” and could compromise patient safety. Read More
Pluristem Therapeutics Inc., of Haifa, Israel, said Austria’s regulatory agency cleared the firm to begin enrollment for a pivotal phase III trial of PLX-PAD cell therapy in critical limb ischemia (CLI). Read More
Alnylam Pharmaceuticals Inc., of Cambridge Mass., and Sanofi Genzyme, a unit of Paris-based Sanofi SA, reported data from an ongoing phase II open-label extension study testing fitusiran in 33 patients with hemophilia A and B, with or without inhibitors. Read More
The FDA’s Oncologic Drugs Advisory Committee (ODAC) will have a lot to consider this week in three days of back-to-back meetings in which it will be asked to weigh in on four different biologic candidates. Read More
LONDON – G20 leaders meeting in Hamburg, Germany, announced the formation of a global body to oversee the discovery and development of new antimicrobial drugs. Read More
The next chapter in the tale of Inotek Pharmaceuticals Corp. is all about “something strategic,” David Southwell, president and CEO, said after the phase II fixed-dose combination (FDC) trial of lead candidate trabodenoson and standard-of-care therapy latanoprost failed to move the needle in treating glaucoma. Read More
HONG KONG – With $13.2 million in new financing, Tokyo-based oncology drug developer Anaeropharma Science Inc. now plans to focus on research and development of drug candidates that target hypoxic microenvironments of tumors by using recombinant Bifidobacterium. Read More
Kala Pharmaceuticals Inc., of Waltham, Mass., has filed its form S1A to offer to sell 6 million shares of its common stock, priced between $14 and $16 per share, in an IPO. Read More
Inmed Pharmaceuticals Inc., of Vancouver, British Columbia, said it entered a research and development collaboration with Atera SAS, of France, a tissue engineering company specializing in the development of advanced human tissue models. Read More
