| U.K. Renounces Vaccine-Autism Study A U.K. medical regulator revoked the license of the doctor who first suggested a link between vaccines and autism and spurred a long-running, heated debate over vaccine safety. online.wsj.com |
Clarient Names Neal S. Goldstein, M.D. Director of Surgical Pathology (PR Newswire) Clarient, Inc. , a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced that Neal S. Goldstein, M.D., has been named the Company's Director of Surgical Pathology. Â He reports directly to Chief Medical Officer Kenneth J. us.rd.yahoo.com |
Genoptix Announces Participation at 2010 Southern California Investor Conference (PR Newswire) Genoptix, Inc. , a specialized laboratory services provider, today announced the Company's participation at the Southern California Investor Conference to be held August 17, 2010 at The Island Hotel, Newport Beach, CA. us.rd.yahoo.com |
Another Big Bet on Obesity: Takeda Puts Orexigen on Solid Ground The Burrill Report submits: By Michael FitzhughJapan's Takeda (TKPHF.PK) is placing summer’s second major bet on an obesity drug with a $50 million investment in Orexigen's (OREX) Contrave, a combination drug meant to help people tackle the biology and behaviors behind overeating. Payments of more than $1 billion await Orexigen if it hits unspecified regulatory and sales-based milestones in the United States, Canada, and Mexico, the countries covered by its new deal with Takeda. Complete Story » seekingalpha.com |
Lilly Antibody Fails in Diabetes Trial: Biotech's Latest Tribulations The Burrill Report submits: MacroGenics and Eli Lilly said teplizumab, an experimental monoclonal antibody for the treatment of type 1 diabetes, failed in a late-stage clinical trial. The Data Monitoring Committee, composed of independent experts in the fields of diabetes and biostatistics, completed a planned analysis of one-year safety and efficacy data of the trial of teplizumab. It concluded that the primary efficacy endpoint of the study, a composite of a patient's total daily insulin usage and HbA1c level at 12 months, was not met. No unanticipated safety issues were identified in the review. Based on the recommendation of the committee, the companies said they have decided to suspend further enrollment and dosing of patients in two other ongoing clinical trials of teplizumab in type 1 diabetes. The U.S. Food and Drug Administration rejected Bydureon, Amylin’s (AMLN) once-weekly diabetes treatment, citing safety concerns regarding the drug’s cardiovascular impact, an issue it had not previously raised. The agency also requested the results of a study that compared the drug to Byetta, a twice-daily injection that contains the same active ingredient as Bydureon. Amylin, Lilly, and their development partner Alkermes (ALKS) hope to submit their reply to the FDA’s request by the end of 2011, pending discussions with the agency.Complete Story » seekingalpha.com |