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USP Opening Office and Laboratory in China
December 8th 2006Rockville, MD ( Dec. 4)-The U.S. Pharmacopeia plans to open a 10,500-square-foot site in Shanghai in February 2007. The facility, in Shanghai's Zhangjiang Hi-Tech Park, will support collaborative testing, technical assistance, customer service, and training.
Merck on Track with Manufacturing Restructuring Plan
December 8th 2006Whitehouse Station, NJ, (Dec. 6)-Merck & Co., Inc. expects the initial phase of its cost-reduction program, first announced in 2005, to yield cumulative pretax savings of $4.5?5.0 billion from 2006 through 2010, with roughly $2 billion of that coming from implementing its manufacturing supply strategy.
Cardinal to Sell $1.8 Billion Contract Services Unit
December 8th 2006Dublin, OH (Nov. 30)-Cardinal Health has announced plans to divest its Pharmaceutical Technologies and Services (PTS) segment, "a business that manufactures or packages 100 billion doses of medication every year for pharmaceutical and biotech firms, employs approximately 10,000 at more than 30 facilities worldwide and generates $1.8 billion in revenue," according to a company statement.
Vial Defects Detected in Roche's Herceptin in Europe
November 30th 2006London (Nov. 22)-The European Medicines Agency reports a defect in some vials of Herceptin (trastuzumab), the anticancer treatment by Roche, which have been distributed in Europe. As a result, The EMEA's Committee for Medicinal Products for Human Use outlined a plan, formulated in conjunction with Roche, for the visually reinspecting and replacing defective vials.
Novartis Plans Additional Data on Manufacturing Issues for Mycograb
November 30th 2006Basel, Switzerland (Nov. 17)-Novartis plans to submit additional information to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on manufacturing issues to support the approval of its antifungal drug "Mycograb." The CHMP issued a negative recommendation for the drug.
BIO Calls for Updating WHO's Naming Policy for Biological Products
November 30th 2006Washington, DC (Nov. 13)-The Biotechnology Industry Organization is urging the World Health Organization to assign a distinct international nonproprietary name (INN) to each unique biological product, including follow-on biologics or biosimilars.
New X-ray Microscopy Method Sheds Light on Nanoscale Reactions
November 30th 2006Argonne, IL (Nov. 9)-Researchers from Argonne National Laboratory?s Chemistry Division and Xradia have developed a novel X-ray microscopy technique that allows molecular observations of the reactivity of solid surfaces at the nanometer scale, including interfacial reactions such as ion adsorption and catalytic reactions.
HHS Awards Contracts for Pandemic Flu Vaccines
November 22nd 2006Washington, DC (Nov. 20)-The US Department of Health and Human Services awarded contracts totaling $199.45 million to Sanofi Pasteur, Novartis, and GlaxoSmithKline PLC to manufacture 5.3 million 90-?g doses of influenza vaccine designed to protect against the H5N1 influenza virus strain.
Perrigo Recalls 11 Million Bottles of Acetaminophen
November 16th 2006Over-the-counter drug maker Perrigo Company issued a voluntary recall of certain lots of store-brand acetaminophen 500-mg caplets that could contain trace amounts of metal particulate. Approximately 11 million bottles of acetaminophen are affected by the recall.
Genentech Agrees to Acquire Tanox for $919 Million
November 16th 2006South San Francisco, CA (Nov. 9)?Genentech, Inc. has agreed to acquire Tanox, Inc., for $20 per share, a total cash value of roughly $919 million. Tanox is a biotechnology company specializing in the discovery and development of biotherapeutics based on monoclonal antibody technology.
Cardinal Health Reports on RFID Pilot
November 16th 2006Dublin, OH (Nov. 14)-A half-year Cardinal Health study of radio-frequency identification (RFID) tags "under real-world conditions has demonstrated that the technology has real promise to provide an added layer of safety," according Renard Jackson, the company's vice-president and general manager of global packaging services, in a prepared statement.
Analysts Present Strategies for Chromatographic Method Development and Validation
November 9th 2006AAPS, San Antonio (Oct. 31-The advantages of ultra-performance liquid chromatography over traditional high-performance liquid chromatographic were the center of the presentation, ?Strategies for Rapid Chromatographic Method Development from Preclinical to Phase 3,? by Charanjeet Jassal of Wyeth Pharmaceuticals.
WHO Urges Immediate Action to Close Vaccine Supply Gap
November 9th 2006Geneva, Switzerland (Oct. 23)-Aiming to increase capacity for producing influenza pandemic vaccines, the World Health Organization has identified strategies and practical solutions for reducing the anticipated gap in the global vaccine supply.
Merck Invests in Formulation R&D and Manufacturing Facility in Ireland
November 9th 2006Dublin, Ireland (Nov. 6)-Merck Sharp & Dohme (Ireland) Ltd., a wholly owned subsidiary of Merck & Co, Inc. plans to establish a formulation-research-and-development and manufacturing facility at its plant in Ballydine, Ireland, according to the Industrial Development Agency Ireland.