| 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 |
Cord Blood America Spokesperson to Hold Webinar on Banking Stem Cells at Birth (PR Newswire) Cord Blood America, Inc. is pleased to announce that Natalie Curry, the Company's official spokesperson and medically saved by the first umbilical cord blood collection in the world, will discuss a wide range of topics about cord blood banking live from CBAI's laboratory in Las Vegas. us.rd.yahoo.com |
Fresh Express Launches Artisanal Salads - Video Salads offer Seasonal Taste in Innovative Natursave™ Packaging feedproxy.google.com |
Roche Plans Cutbacks on Pressure From Failures: Biotech's Latest Mishaps The Burrill Report submits: Swiss pharmaceutical giant Roche (RHHBY.PK), stung by recent setbacks and concerned about tightening healthcare budgets, said it will institute a cost-cutting plan. The company, which offered no detail on how deeply it would cut costs or where it would seek savings, said all parts of the organization are undergoing review and analysis and it would have specific measures in place and the potential impact on staffing by year end. The company said despite tightening healthcare budgets, it expects payers will increase allocations for treatments and diagnostic tools providing the highest medical value for patients. Part of its plan is to set the right priorities to ensure a success in the changing healthcare environment. Roche is awaiting a decision from the U.S. Food and Drug Administration as to whether the agency will follow the recommendation of an advisory panel and revoke its approval of the use of its drug Avastin in breast cancer. Roche’s setbacks in recent months include its failure to expand the use of Avastin for gastric cancer, the inability to win priority review for its experimental drug T-DM1, and the scrapping of its Rituxan successor. Celldex Therapeutics (CLDX) fell nearly 40 percent after it announced that Pfizer (PFE) has terminated its development and commercialization agreement for the cancer vaccine rindopepimut. Celldex will regain full worldwide rights November 1 to the therapeutic vaccine that targets the tumor-specific molecule EGFRvIII in patents with glioblastoma multiform, the most common form of brain cancer. Celldex and Pfizer Vaccines entered into a global development and commercialization agreement in April 2008 for rindopepimut. Pfizer told the company that the program is no longer a strategic priority for Pfizer. Celldex said rindopepimut has met or exceeded all pre-determined safety and efficacy objectives. The program has completed a multi-center phase 2 study, the development of a diagnostic companion product, the manufacture of drug supply for clinical studies, and the execution of discussions with regulatory agencies on the design of a global controlled study.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 |