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.
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).
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.
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.
LONDON – G20 leaders meeting in Hamburg, Germany, announced the formation of a global body to oversee the discovery and development of new antimicrobial drugs.
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.
Peregrine Pharmaceuticals Inc., of Tustin, Calif., said a previously approved 1-for-7 reverse split of its outstanding shares of common stock took effect Friday, July 7, and will begin trading on Nasdaq Monday, July 10, on a split-adjusted basis under the existing trading symbol PPHM.
Alk-Abello A/S, of Horsholm, Denmark, released further analysis of data from its landmark five-year Grazax asthma prevention (GAP) trial in children. The analysis, which appears online in The Journal of Allergy and Clinical Immunology, shows that the benefits of Grazax in prevention of asthma symptoms were even more pronounced when treatment was initiated at an earlier age.
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