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Join FDAnews Tuesday, Oct. 31, for "Adaptive Clinical Trial Design: How to Lower Costs and Shorten Product Development Cycles." In this 90-minute interactive audioconference, Jerald S. Schindler, Dr.PH, president of Cytel Pharmaceutical Research Division, will explain how these trials can provide more information on a drug's efficacy, how they can result in a more ethical trial, how they can rescue a drug and how all this can be done without compromising the integrity of a trial. On Nov. 6, join FDAnews for "Proactive Planning for Recalls." In this 90-minute audioconference with Q&A session, noted attorney and author James M. Wood will share his proactive plan -- developed from real-world lessons he's learned during 30 years representing prescription medicine and medical device manufacturers -- on matters ranging from product recalls to off-label and liability issues.
Sanofi-aventis announced that, following a priority review of its supplemental new drug application (sNDA), the FDA has approved Taxotere (docetaxel) Injection Concentrate in combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable, locally advanced, squamous-cell carcinoma of the head and neck.
Epix Pharmaceuticals has announced that preclinical data from studies on obesity and cognitive impairment with PRX-07034, a highly selective 5-HT6 receptor antagonist, were presented at the Society for Neuroscience annual meeting in Atlanta.
Sanofi pasteur, the vaccines business of sanofi-aventis, announced that its H5N1 pre-pandemic vaccine induces antibodies that neutralize additional H5N1 circulating virus not included in the original vaccine formulation.
Sosei has announced that AD 337, a novel enantiomer of an approved centrally acting non-opioid analgesic, has entered a Phase II proof-of-principle trial for the treatment of fibromyalgia syndrome (FMS).
Human Genome Sciences (HGS) has reported 12-week interim quality-of-life results from a Phase IIb clinical trial to evaluate the efficacy, safety and impact on health-related quality of life of Albuferon in combination with ribavirin in patients with genotype 1 chronic hepatitis C who are naive to interferon alpha-based treatment regimens.
Avanir Pharmaceuticals announced that results of a Phase II clinical trial evaluating escalating doses of Neurodex in the treatment of painful diabetic neuropathy were published for the first time in the October issue of Clinical Therapeutics.