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Barr Pharmaceuticals announced that its subsidiary, Barr Laboratories, has received tentative approval from the FDA for its generic version of Roche's Kytril (granisetron hydrochloride) tablets, 1 mg.
Acambis announced it has received a complete response letter from the FDA for its biologics license application (BLA) for its ACAM2000 cell-culture smallpox vaccine.
GlaxoSmithKline (GSK) has begun a study designed to compare the immunogenicity of its experimental cervical cancer vaccine, Cervarix, with Merck's Gardasil.
Neuren Pharmaceuticals has successfully completed a Phase I safety and tolerability trial of its second lead candidate, NNZ-2566, which is being developed to treat traumatic brain injury.
Anesiva has announced data from a Phase I safety study of product candidate 1207, which was being tested as a topical anesthetic for treatment of neuropathic patients.
Barrier Therapeutics announced results of a Phase IIa proof-of-concept study of oral Hivenyl in the treatment of moderate to severe itching related to atopic dermatitis that indicate that Hivenyl significantly reduces itch symptoms without signs of sedation.
MediciNova announced the results from its Phase II/III randomized, double-blind, placebo-controlled clinical trial of MN-001 in 305 patients with moderate-to-severe interstitial cystitis (IC), a chronic disease of the bladder.
Sanofi-aventis announced results of a large randomized Phase III study (ACTS-GC) showing that the oral anticancer agent S-1 reduced the relative risk of death in early stage gastric cancer patients by a significant 32 percent compared with curative surgery alone.