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August 23, 2007 Notes: AstraZeneca selects Axway's supply-chain tracking technology, Biovex names vice-president of quality assurance, more.
Scottsdale, AZ (Aug. 20)-AstraZeneca selected Axway’s "Synchrony" supply-chain integrity suite to enable track-and-trace as part of product safety data management (PSDM) initiative. AstraZeneca’s PSDM initiative implements a global infrastructure and strategy across multiple packaging lines and production sites. The initial scope of PSDM includes 25 packaging lines and 12 worldwide sites, not including the US sites or supply chain.
Chennai, India (Aug. 17)-Atlas Weathering Services Group, a division of Atlas Material Testing Technology, will open a new outdoor exposure site near Chennai, India, on Aug. 31. Located in the southeast region of India, which is characterized by a tropical climate with high levels of sunlight, humidity, and temperature, the new site will be the country’s first outdoor exposure site.
Deerfield, IL and London (Aug. 16)-Baxter International announced that its subsidiary in the United Kingdom entered into an advanced supply agreement with the UK Department of Health that contains an option to purchase pandemic influenza vaccine in the event that the World Health Organization declares a pandemic. Baxter will manufacture its pandemic vaccine in a serum-free, vero cell-based system at one of the largest cell-culture vaccine facilities in the world.
Winnipeg, MB, Canada (Aug. 16)-Cangene reported that its contract with the US Centers for Disease Control and Prevention for the supply of vaccinia immune globulin intravenous (human) (VIG) was extended for five more years. The original five-year contract was signed in August 2002. Under that contract, Cangene developed and delivered VIG product to the US Strategic National Stockpile.
London (Aug. 20)-Chi-Med's Hutchison MediPharma R&D Limited (Hutchison MediPharma), entered into a drug discovery and development agreement with Eli Lilly and Company (Indianapolis, IN). Lilly and Hutchison MediPharma will initially collaborate on the discovery and development of pharmaceutical agents focused on targets in oncology and inflammation. Hutchison MediPharma will assume primary responsibility for the discovery phase activities necessary for the identification and selection of several clinical candidates and Lilly will be responsible for ongoing technical advice and the subsequent Investigational New Drug filing and clinical development of these candidates.
New York (Aug. 20)-ImClone Systems, a developer of novel cancer therapeutics, received approval from the US Food and Drug Administration for its second facility to manufacture “Erbitux.” The approval to manufacture Erbitux in the new 250,000-ft.2 multisuite manufacturing facility, referred to as BB50, more than doubles ImClone’s total available production-volume capacity.
Billerica, MA (Aug. 15)-Millipore expanded its agreement with Novo Nordisk to provide the biopharmaceutical market with recombinant human insulin, a key cell-culture supplement used to manufacture biologic drugs. Under the terms of the agreement, Millipore will have exclusive worldwide rights to market and sell Novo Nordisk’s recombinant human insulin, branded by Millipore as “Incelligent SG” and “Incelligent AF,” for cell-culture media applications.
Irvine, CA (Aug. 16)-Nexgen Pharma acquired certain assets of The Chemins Company located in Colorado Springs, Colorado. The acquired assets include 250,000 ft.2 of manufacturing, laboratory, and warehouse and distribution space.
Miami (Aug. 15)-Noven Pharmaceuticals completed its previously announced acquisition of JDS Pharmaceuticals. JDS is a specialty pharmaceutical company that currently markets two branded prescription psychiatry products and focuses on products in psychiatry and women’s health.
New York (Aug. 17)-A bid by Pfizer to win reissuance of a US patent protecting its Lipitor cholesterol medicine has been rejected on a preliminary basis by the US Patent and Trademark Office. The current patent lasts until March 2010; the patent extension would protect the drug’s exclusivity for an additional 15 months.
San Diego, CA (Aug. 16)-Pharmatek Laboratories added cytotoxic and high-potent drug development capabilities to its pharmaceutical chemistry development services. Cytotoxic and high-potent services include analytical method development, preformulation testing, formulation development, manufacturing for early-phase clinical trials, release testing, and stability testing and storage.
Princeton, NJ (Aug. 20)-Ranbaxy Pharmaceuticals, a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), received approval from the US Food and Drug Administration to manufacture and market hydrocodone bitartrate and acetaminophen tablets USP in 7.5-mg/750-mg, 10-mg/500-mg, 5-mg/500-mg, and 10-mg/325-mg strengths. The Office of Generic Drugs determined the Ranbaxy formulations to be bioequivalent and to have the same therapeutic effect as that of the reference listed drugs.
Milford, MA (Aug. 16)-Waters acquired Calorimetry Sciences Corporation (CSC), a manufacturer of high-performance calorimeters. The CSC business, with annual sales of approximately $4 million, will be added to Waters’s TA Instruments Division, and the transaction is not expected to affect Waters 2007 earnings.
Woburn, MA (Aug. 15)-BioVex, a biotechnology company developing clinical-stage treatments, appointed Dr. Thaddeus Pullano, 53, as vice-president of quality assurance.
Stockholm, Sweden (Aug. 17)-Orexo appointed three senior executives: Mats Eriksson, PhD, to vice-president of research and clinical development and medical director; Christina Ståhl, MSc. Pharm, to vice-president of regulatory affairs; and Anne Marie Ciupitu, MSc, PhD, to director of quality assurance and quality control.
Plymouth, MN (Aug. 20)-PlaCor appointed John Reinke to chief executive officer, effective September 4, 2007. William S. Haworth was named chief technology officer and will focus on the development of the company’s platelet reactivity testing technology.
Fremont, CA (Aug. 21)-PDL BioPharma said chief executive Mark McDade will resign by the end of 2007 and that an internal investigation found no credible evidence of improper personal conduct or breach of fiduciary duty.