GSK seeks prequalification for Cervarix⢠from the World Health Organization
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- Category: GlaxoSmithKline
GlaxoSmithKline (GSK) announced that it has submitted a file on its cervical cancer vaccine, Cervarix™, to the World Health Organization (WHO) for pre-qualification, following the granting of a marketing authorisation approval by regulatory authorities in Europe on 20 September.
Shire's ELAPRASE® (idursulfase) Approved in Japan For the Treatment of Hunter Syndrome
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- Category: Shire
Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that Japan's Ministry of Health, Labour and Welfare has approved ELAPRASE, a human enzyme replacement therapy for the treatment of Hunter syndrome, for sale and marketing in Japan. Since its U.S. approval in July 2006, ELAPRASE is now approved for marketing and commercial distribution in 34 countries worldwide.
Pfizer Launches Independent Biotherapeutics and Bioinnovation Center
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- Category: Pfizer
Pfizer named Dr. Martin Mackay as President of Pfizer Global Research and Development (PGRD); launched an independent, stand-alone biotherapeutics and bioinnovation center under the direction of scientist and entrepreneur Dr. Corey Goodman; and named Dr. Briggs Morrison, who held senior research and development positions at Merck, as its new Head of Clinical Development for the PGRD pipeline.
Boehringer Ingelheim comments the nevirapine production for Rwanda by Apotex
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- Category: Boehringer Ingelheim
On Sept. 19th, 2007, the Canadian Patent Office (CIPO) granted an authorisation to the Canadian generic manufacturer Apotex Inc. for the production of a certain volume of APO-TRIOVIR for export into Rwanda. This HIV medicament is a fixed dose combination of three active ingredients, one of which is nevirapine patented for Boehringer Ingelheim.
GSK applies for licence to market OTC weight loss product In Europe
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- Category: GlaxoSmithKline
GlaxoSmithKline (GSK) announced its marketing application for non-prescription orlistat 60mg for weight loss has been accepted for review by the European Agency for the Evaluation of Medicinal Products (EMEA). Orlistat 60 mg was approved for non-prescription sale in the US by the FDA in February 2007 for use by overweight adults in conjunction with a reduced-calorie, low-fat dietand went on sale there in June 2007 under the brand name alli™.
Herceptin eradicates tumours and may reduce the need for mastectomies
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- Category: Roche
New data show that the addition of Herceptin (trastuzumab) to chemotherapy prior to breast cancer surgery (neoadjuvant therapy) completely eradicates tumours in nearly three times as many women with inflammatory HER2-positive breast cancer compared to chemotherapy alone. Inflammatory breast cancer is a rare, but highly aggressive form of the disease - the tumours spread quickly, often leading to the need for total mastectomies, and it has a worse outlook than other breast cancers.
Bionas Signs Service Contract with Solvay Pharmaceuticals
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- Category: Business
Bionas GmbH, a specialist for in vitro profiling of cellular metabolic activity, announced that it has signed a service contract with Solvay Pharmaceuticals GmbH (Hannover, Germany). The contract covers the metabolic profiling of several drug candidates identified in the context of Solvay's obesity research program. Financial details were not disclosed.
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