Feds to Devote New Funds to Fight Flu, Bioterror

WASHINGTON (MedPage Today) — The Obama administration announced that it plans to invest nearly $2 billion in measures to beef up the nation’s ability to respond to bioterrorism and pandemic threats, including $822 million for pandemic influenza vaccine development.

Benefit, Cost at Odds in Gastric CA (CME/CE, with video)

(MedPage Today) — Patients with advanced gastric cancer lived about three months longer when trastuzumab (Herceptin) was added to conventional chemotherapy, investigators in a multinational trial reported.

FDA Panel Roundly Rejects CNS Drug for Fibromyalgia

BETHESDA, Md. (MedPage Today) — A federal advisory panel has voted 20-2 to recommend that the FDA not grant approval for an expanded indication for sodium oxybate (Xyrem) — also known as GHB — to treat fibromyalgia.

FDA Panel Roundly Rejects CNS Drug for Fibromyalgia

BETHESDA, Md. (MedPage Today) — A federal advisory panel has voted 20-2 to recommend that the FDA not grant approval for an expanded indication for sodium oxybate (Xyrem) — also known as GHB — to treat fibromyalgia.

Jazz Pharmaceuticals disappointed with FDA Advisory Committee recommendation for JZP-6 in fibromyalgia

Jazz Pharmaceuticals, Inc. announced today that the Joint Advisory Committee of the U.S. Food and Drug Administration (FDA), including the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted 20-2 that the benefit/risk balance did not support the approval of JZP-6 for the treatment of with the currently proposed Risk Evaluation [...]

‘Yakult’ effective in reducing acute diarrhea in young children: Study

YAKULT HONSHA CO., LTD. announced on August 20 that its collaborative study on the incidence of acute diarrhea with the National Institute of Cholera and Enteric Diseases in Kolkata, India, showed that daily intake of “Yakult” is efficacious in reducing the incidence of diarrhea in young children.

GlaxoSmithKline And Human Genome Sciences Announce FDA Priority Review Designation For Benlysta® (belimumab)

GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted a priority review designation to Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus (SLE)…

Biogen Idec And Knopp Neurosciences Announce License Agreement For Late-Stage ALS Drug Candidate

Biogen Idec (NASDAQ: BIIB) and Knopp Neurosciences announced they have entered into an exclusive, worldwide license agreement under which Biogen Idec will develop and commercialize KNS-760704 (dexpramipexole) for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, and potentially other indications…

Approval Of Additional Indication Of NESINA®: Combination Therapy With Thiazolidinediones For Type 2 Diabetes In Japan

Takeda Pharmaceutical Company Limited (”Takeda”) announced that an additional indication for “NESINA®” (generic name: Alogliptin), combination therapy with thiazolidinediones for type 2 diabetes, was approved by the Japanese Ministry of Health, Labour and Welfare. NESINA, a dipeptidyl peptidase-IV (DPP-4) inhibitor created by Takeda San Diego, Inc…

Arqule And Daiichi Sankyo Move Forward With Phase 3 Clinical Trial Plan For Arq 197 In Non-Small Cell Lung Cancer

ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo Co., Ltd. (TSE 4568) announced that they will move forward with a Phase 3 clinical trial of ARQ 197, a small molecule inhibitor of the c-Met receptor tyrosine kinase, in patients with non-small cell lung cancer (NSCLC). In connection with this decision, the sponsor company, Daiichi Sankyo, will [...]