Posted on October 2, 2008 @ 09:00 am
Merck has decided not to seek regulatory approval for taranabant, an investigational drug to treat obesity, and is discontinuing its Phase III development program for taranabant in obesity. The drug is similar to Acomplia, the Sanofi-Aventis obesity drug that was rejected by the FDA because of adverse events.
"Available Phase III data showed that both efficacy and adverse events were dose related, with greater efficacy and more adverse events in the higher doses. Therefore, after careful consideration, we determined that the overall profile of taranabant does not support further development for obesity," said John Amatruda, M.D., senior vice president and research head, diabetes and obesity, Merck Research Labs. "We thank the patients and investigators around the world who collaborated with us on the research program for taranabant and look forward to developing new medicines for obesity to address the significant medical need posed by this disease."
Posted on October 2, 2008 @ 08:59 am
Christopher Perley has been named vice president and general manager of
Bristol-Myers Squibb's Devens biologics manufacturing facility. Mr. Perley will be responsible for continuing the supervision of the project to build the Devens facility and will have overall management responsibility for the site when it becomes operational in 2011.
“With an approved capital expenditure of $750 million, the Devens facility represents the largest capital investment in the history of Bristol-Myers Squibb,” said Carlo de Notaristefani, president of technical operations, BMS. “As the company evolves toward a next-generation biopharma model, combining the best of biotech with the best of a traditional pharmaceutical company, biologics will play an increasingly important role in driving our company’s future growth and success, and will be key in helping patients prevail over serious disease. Chris brings extensive biopharmaceutical experience that will support the company in this transition.”
Prior to joining the company, Mr. Perley was vice president of network strategy at Wyeth Biotech, where he gained experience in biopharmaceutical process development, production, supply chain management, and operations. Previously, he held manufacturing and biotechnology process development roles at the Genetics Institute in Andover, MA, and at Hoffmann-La Roche in Nutley, NJ.
Posted on October 2, 2008 @ 08:57 am
Biologic Safety Research, Inc. (BSR) is joining PreLabs, LLC to expand their contract laboratory operations. The existing BSR management team will integrate into the PreLabs organization and continue to guide the expanded group. PreLabs appointed Boris Predovich to serve as president and chief executive officer and Philippe Baneux, DVM to serve as chief scientific officer for the newly expanded company. PreLabs/BSR will provide discovery, preclinical and GLP testing.
“Market demand has created an exciting opportunity for us to expand our business,” said Robert Locke, BSR president. “Transitioning BSR into PreLabs will leverage our existing scientific and operational expertise while adding the CRO and pharmaceutical management expertise that Boris Predovich and Philippe Baneux bring with their 20 plus years at Covance and Pfizer, respectively.”