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Also, Shire recalls "Daytrana" patch, Chromatide forms Scientific Advisory Board, more...
Redwood City, CA (Aug. 25)-Codexis, a provider of biocatalysis technology, and Arch Pharmalabs Limited (Mumbai, India), an active pharmaceutical ingredients (APIs) and intermediates manufacturer, announced a collaboration that expands their three-year partnership in pharmaceuticals manufacturing. Codexis will offer multiple pharmaceutical intermediates and APIs made with its proprietary biocatalytic processes to both innovator and generic drug manufacturers. Sales in India will be through its subsidiary, Codexis Laboratories India Private Limited. Arch has 10 facilities throughout India, and will be Codexis' exclusive manufacturer for these products. The two companies will also comarket products.
Phillipsburg, NJ (Aug. 21)-Covidien announced the launch of the Mallinckrodt Baker Certified Excipient Distributor Program, which is designed to align Mallinckrodt Baker and select channel partners to provide the pharmaceutical industry with an optimized supply chain that is compliant with the International Pharmaceutical Excipient Council's (IPEC) guidelines for good distribution practices. Covidien also announced that Brand-Nu Laboratories and Doe and Ingalls of North Carolina are the first distributors to attain certified status under the program.
Foster City, CA (Aug. 25)-Gilead Sciences plans to nearly double the office and research and development (R&D) space at its Foster City, California, headquarters as it adds 1,900 jobs there over the next 10 years. The company will raze eight one- or two-story office/R&D buildings and construct up to seven new buildings, including as many as three 8- to 10-story office buildings and up to four two- to four-story laboratory buildings for manufacturing and pilot production. The project may increase Gilead’s campus from 629,154 ft2 to 1.2 million ft2. Construction is expected to begin in early 2009.
Thousand Oaks, CA (Aug. 22)-FDA approved Amgen’s (Thousand Oaks, CA) “Nplate” (romiplostim), the first platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the first FDA-approved peptibody protein, works by raising and sustaining platelet counts, representing a novel approach for the long-term treatment of this chronic disease. The approval came after two Phase III studies of adult patients with chronic ITP, including both splenectomized and non-splenectomized patients. Amgen plans to launch the Nplate NEXUS (Network of EXperts Understanding and Supporting Nplate and Patients) Program to provide access, support, and education for chronic ITP patents and their caregivers. The program is part of Amgen’s Risk Evaluation and Mitigation Strategy developed in partnership with the FDA.
Rockville, MD (Aug. 26)-FDA sent a warning letter to Novartis’s generics unit, Sandoz, regarding a failure to properly validate the manufacturing process for a copied version of AstraZeneca’s “Toprol XL,” a blood pressure medication, at its North Carolina plant.
Miami, FL (Aug. 20)-Noven Pharmaceuticals entered into global license and supply agreements with Procter & Gamble Pharmaceuticals (Cincinnati, Ohio), a subsidiary of The Procter & Gamble Company, relating to the development and commercialization of prescription transdermal patches for the treatment of hypoactive sexual desire disorder (HSDD) in women. Procter & Gamble gains an exclusive worldwide license to a testosterone patch for the treatment of HSDD in women, as well as potential next-generation patches in the same therapeutic category.
Rivera Beach, FL (Aug. 21)-Sancilio & Company opened a new 2000-ft2 contract
manufacturing facility in Rivera Beach, Florida, which specializes in small batch manufacturing of tablets and capsules as well as packaging and labeling services.
Wayne, PA (Aug. 25)-Shire is recalling two lots of the attention deficit hyperactivity disorder patch “Daytrana” (lots 2819811 and 2764211; NDC number is 54092-553-30) because these lots do not meet their release liner removal specification. As a result, patients and caregivers could have difficulties removing the liners. This voluntary recall is not due to product safety issues, says Shire. Read the company's announcement here.
Wilmington, NC (Aug. 25)-AAIPharma appointed Scott Neilson chief operating officer, responsible for the company’s global drug development services operations. Neilson has spent more than 25 years working in all phases of drug development on a global basis, including jobs at MDS Pharma Services, LabCorp, Covance, and SmithKline Beecham (now GlaxoSmithKline).
Cheshire, England (Aug. 18)-Chromatide, a provider of polymer technologies, announced the formation of a Scientific Advisory Board. Each member of the board has been involved in the pharmaceutical, biotechnology, and chemistry sectors for more than 25 years. Members include Nigel Slater, Brian Adger, and Eric Atherton, as well as representatives from GlaxoSmithKline, Sterling Organics, Great Lakes Chemical Europe, Chiroscience, Avecia, Zeneca, ICI, Unilever, and Wellcome.
Greenville, NC (Aug. 20)-Metrics announced that Vice-President of Pharmaceutical Development Michael D. Ruff received his clinical doctor of pharmacy degree from the Shenandoah University Bernard J. Dunn College of Pharmacy. Ruff, who has been with Metrics for 11 years, is the ninth person to earn the new Certified Pharmaceutical Industry Professional (CPIP) credential.
Shanghai, China (Aug. 22)-WuXi PharmaTech, a research and development outsourcing company with operations in China and the United States, promoted Rujian Ma to vice-president of Synthetic Chemistry. Ma joined WuXi in March 2001.