• Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said results from the pivotal Phase III GEMINI trial showed that, after six weeks of induction therapy, 47. 1 percent of patients with moderately to severely active ulcerative colitis who received gut-selective monoclonal antibody vedolizumab experienced clinical response vs. 25.5 percent in the placebo group (p < 0.0001). Read More
• Celtic Pharmaceutical Holdings LP, of New York, said it completed a Phase I/II study of Xerecept (corticorelin acetate) in pediatric patients who are dependent on the steroid Decadron (dexamethasone) to treat peritumoral brain edema associated with cerebral tumors. Initial indications from the 15-patient study indicated that Xerecept can reduce or eliminate the need for Decadron use and provide significant quality of life improvements. Read More
• KemPharm Inc., of North Liberty, Iowa, disclosed the final resolution of its litigation with Shire LLC, a division of Dublin, Ireland-based Shire plc, with all pending claims and counterclaims dismissed with prejudice. Read More
• Halo Therapeutics LLC, of Newton, Mass., received funding of $1.1 million from 12 nonprofit foundations dedicated to muscular dystrophy. Halo will use the funding to support its Phase II trial of HT-100 for Duchenne's muscular dystrophy. Read More
LONDON – The timing could not have been better. The international stem cell community getting together in London was able to applaud the breakthrough signified by Health Canada's approval of Prochymal, Osiris Therapeutics Inc.'s allogeneic stem cell treatment for graft-vs.-host disease, and rejoice in the knowledge that there is light at the end of the regulatory tunnel. Read More
To almost no one's surprise, another potential treatment in non-small-cell lung cancer (NSCLC) bit the dust as Nexavar (sorafenib) failed to meet the primary endpoint of improving overall survival (OS) in the Phase III MISSION (Monotherapy admInistration of Sorafenib in patientS wIth nOn-small cell luNg cancer) trial in patients with advanced relapsed or refractory nonsquamous disease. Read More
Even though Pfizer Inc.'s Vyndaqel already is approved in Europe, getting U.S. approval for the orphan drug on the strength of a single pivotal trial is looking like it could be an uphill battle. Read More
InterMune Inc. agreed to sell its rights to Actimmune (interferon gamma-1b) to Vidara Therapeutics International Ltd. for $55 million in cash plus royalties for two years. InterMune's CEO Dan Welch said divesting Actimmune would free up capital for development and registration of Esbriet (perfenidone) in Europe and other territories, and support other research and development activities. Read More
• Novo Nordisk A/S, of Bagsvaerd, Denmark, said the FDA approved Levemir (insulin detemir [rDNA origin] injection) for use in children, ages 2 to 5, with Type I diabetes. Read More
