October 20th 2025
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PhRMA Reports Identifies More than 400 Biotech Drugs in Development
August 24th 2006Washington, DC (Aug. 14)?A new report issued by the Pharmaceutical Research and Manufacturers of America identifies 418 drugs and vaccines developed through biotechnology. All of the biotechnology medicines and vaccines are now in clinical trials or awaiting approval by the US Food and Drug Administration (Rockville, MD).
ISO Publishes New Cleanrooms Contamination Standard
August 24th 2006The International Organization for Standardization (ISO, www.iso.org) has formally issued and published standard ISO 4644-8:2006, Cleanrooms and associated controlled environments-Part 8: Classification of airborne molecular contamination. The document covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments in terms of airborne concentrations of specific chemical substances (individual, group, or category) and provides a protocol to include test methods, analysis, and time-weighted factors within the specification for classification.
Cracking Down on Counterfeiting
August 2nd 2006Disappointed in progress thus far, the US Food and Drug Administration wants pharmaceutical manufacturers to make a greater effort to combat counterfeit products and recommends that they "move quickly" to implement radio-frequency identification technology.
FDA Approves Additional Manufacturing at Genzyme's Ireland Plant
July 27th 2006Genzyme Corporation (Cambridge, MA) reports the US Food and Drug Administration (Rockville, MD) has approved the fill?finishing, packaging, and labeling of "Thymoglobulin" (antithymocyte globulin, rabbit) at its Waterford, Ireland facility. The approval allows Genzyme to begin manufacturing and distribution of Thymoglobulin from this facility.
MHRA Renews Recall of Counterfeit Lipitor
July 27th 2006The UK Medicines and Healthcare Products Regulatory Agency (MHRA, London) has reissued its recall of a specific batch of counterfeit ?Lipitor? 20-mg tablets. MHRA, in conjunction with Pfizer (New York City, NY), first issued the recall of batch number 004405K1 in July 2005. The new recall is in response to the discovery of more packages of the counterfeit drug in the United Kingdom.
SAP Cofounder Forms New Pharmaceutical Company
July 20th 2006Dietmar Hopp, cofounder of the German information technology giant SAP AG (Waldorff, Germany) is forming a new pharmaceutical company from the merger of two German biopharmaceutical companies: Axaron Bioscience AG (Heidelberg, Germany) and Lion Bioscience AG (Heidelberg, Germany).
Ranbaxy Acquires GSK's Mundogen Generic Drug Business
July 20th 2006In a move to strengthen its position in Western generic drug markets, Ranbaxy Laboratories Ltd. (Gurgaon, Haryana, India) acquired the Mundogen generic drug business of GlaxoSmithKline (GSK, London, England) in Spain, through Ranbaxy's Spanish subsidiary, Laboratorios Ranbaxy S.L.
Tufts Study Points to Slow Growth for Anti-Infective Vaccines
July 13th 2006Although the number of anti-infective vaccines (as distinct from therapeutic vaccines for cancers and other noninfectious diseases) entering clinical study each year since 2000 has been higher on average than it was in the 1990s, this product area may see little additional growth through the rest of this decade, according to a recentanalysis from the Tufts Center for the Study of Drug Development (Boston, MA).
Warning Letter: Sanofi Pasteur
July 6th 2006Vaccine maker Sanofi Pasteur, Inc. received a US Food and Drug Administration Warning Letter, dated June 30, citing "significant deviations" from current good manufacturing practices in the production of monovalent concentrates used in the company?s ?Fluzone? influenza vaccine.
Crucell, DSM To Open Biotech R&D Center
July 6th 2006Dutch biotechnology company Crucell NV (Leiden, Netherlands) and its technology partner DSM Biologics BV, a business unit of Royal DSM NV (Heerlen, Netherlands) will open a new research and development center that will specialize on further developing the "PER.C6" human cell line for the expression of recombinant pharmaceutical proteins.
MedImmune Advances Vaccine Program
July 6th 2006MedImmune, Inc. (Gaitherburg, MD) reports that US Food and Drug Administration (Rockville, MD) has approved the company's supplemental biologics license application to use reverse genetics technology to construct new vaccine strains to produce seasonal influenza vaccines.
Hep E Vaccine Developed Using Novel Liposome Technology
July 6th 2006Biopharmaceutical company Lipoxen PLC (London, UK) has developed a Hepatitis E vaccine using its novel vaccine delivery technology "ImuXen," which the company claims to be easy to manufacture. According to the company, the proprietary liposomal formulation method delivers vaccine materials to the immune system in a manner designed to emulate the response of a natural encounter with the infection agent.