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Novartis CEO To Step Down; DSM To Close Netherlands Facility; And More.
The specialty pharmaceutical company AlphaRx (Markham, Canada) announced that its licensee, Gaia BioPharma (Hong Kong), a biopharmaceutical company, signed an agreement with a contract manufacturing organization to manufacture GAI-122 for use in Phase I and Phase II clinical trials. GAI-122 is being developed as an intravenous-administered formulation of an intracellular neuroprotectant that uses AlphaRx's proprietary nanoemulsion formulation technology. GAI-122 has the potential to treat patients with acute ischemic stroke or to prevent postoperative delirium.
The contract manufacturing organization AMRI (Albany, NY) received certification by SafeBridge Consultants (Mountain View, CA) of its high-potency research laboratories and good manufacturing practice facilities in Rensselaer, New York. The certification applies to specific AMRI laboratories and manufacturing areas designed for the research, development, and manufacture of potent compounds and certifies AMRI is competent and proficient in the safe handling of potent active pharmaceutical ingredients.
DSM Specialty Intermediates, a business unit of Royal DSM NV (Heerlen, The Netherlands) will cease operations by the end of 2010. The company’s Chemelot industrial site in Sittard-Geleen, The Netherlands, is scheduled to close during July 2010, resulting in the loss of 37 jobs. DSM Specialty Intermediates produces intermediates for the pharmaceutical, food, and automotive industries.
NextPharma Technologies (Surrey, UK), a contract provider of pharmaceutical development, manufacturing, cold-chain, and distribution services, received approval from Austrian regulatory officials for its expanded temperature-controlled storage facilities in Stockerau, Austria.
Patheon (Research Triangle Park, NC), a contract provider of pharmaceutical development and manufacturing services, began construction of a pharmaceutical-development center at its facility in Bourgoin, France. The new facility is designed for late-phase, clinical-trial tablets and capsule products, and will be capable of handling batch sizes up to 120 kg.
Ricerca Biosciences (Concord, OH), a contract provider of pharmaceutical development and manufacturing services, announced the validation of the Watson Laboratory Information Management System for its Bioanalysis Division. The system will help Ricerca electronically track shipments and samples and handle standard to complex protocols, enabling greater productivity in the laboratory and faster turnaround times.
The chemical company Wacker Chemie (Munich, Germany), which includes Wacker Biotech, a contract manufacturer of biopharmaceuticals derived from microbial systems, and the biotechnology company MorphoSys (Planegg, Germany) expanded their cooperation agreement to include use of Wacker’s technology for the production of antigen material. The expanded agreement also covers the production of antibodies in both the early-development phase of therapeutic projects and in the production of diagnostic and research antibodies.
Novartis (Basel) announced that Daniel Vasella will step down next month as the company’s chief executive officer. Vasella, who will keep his position as chairman, will be replaced by Joe Jimenez, who heads Novartis’ pharmaceutical unit.
The US Food and Drug Administration named Jeffrey E. Shuren director of the Center for Devices and Radiological Health. Shuren, acting director since September 2009, has held various positions at FDA, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy.
American Society of Quality (ASQ) awarded fellow status to William B. Stinchcomb of Abbott Laboratories (Abbott Park, IL). Stinchcomb was recognized by ASQ for “significant contributions in sharing best practices for assuring data quality, integrity, and security; and for demonstrating lifelong learning of quality technical knowledge and sharing this knowledge through education and mentoring programs.”