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Also, Human Genome Sciences enters pact with Hospira, Zosano Pharma names Gail Schulze chair and CEO, more...
Westbrook, ME (Sept. 8)-ARTEL, a provider of liquid-handling quality assurance, opened an office in Montréal, Québec, Canada to meet growing demand for its liquid handling quality-assurance products and services in the region. ARTEL Canada will provide technical support and training to help laboratories optimize their pipetting and automated liquid-handling operations and improve data quality.
San Francisco (Sept. 4)-Bilcare Global Clinical Supplies, a provider of clinical trial supplies and services, enhanced its global Phase III capabilities. Its latest investments include the upgrade of its "Kalish" large-scale bottling line at its US facility and an investment in new "Pentapack" blistering technology for expanded packaging capabilities in America and Europe.
Waiblingen, Germany (Sept. 5)-Bosch Packaging Technology plans to acquire Paal Verpackungsmaschinen (Remshalden, Germany), a company focused on packaging and automation. The purchase agreement was signed on Sept. 5, 2008, and the deal is subject to customary regulatory approval. Financial details were not disclosed.
Research Triangle Park, NC (Sept. 8)-Cirrus Pharmaceuticals, a contract research organization, will expand its capacity for stability storage via the addition of three "Luwa" walk-in stability chambers, each with 1100 ft3 of storage space. The chambers will be CGMP-compliant meeting FDA and ICH guideline requirements for stability. The company expects validation of the chambers, including temperature and humidity mapping and monitoring systems, to be completed by November 2008.
Rockville, MD (Sept. 4)-Human Genome Sciences, a biopharmaceutical company focused on protein and antibody process development and manufacturing, entered into an exclusive agreement with Hospira (Lake Forest, IL), a global specialty pharmaceutical company, for manufacturing process development and commercial supply of select Hospira biopharmaceutical products. Financial terms were not disclosed, and specific products were not identified.
Uppsala, Sweden (Sept. 8)-Orexo, a pharmaceutical company, and Boehringer Ingelheim (Ingelheim, Germany), have extended their three-year research collaboration for an additional 12 months from November 2008. The collaboration focuses on developing and marketing a new class of drugs with a novel mechanism of action for the treatment of pain and inflammation. The new pact acts as an extension to the original agreement between the two companies dating from 2005; the deal has a total potential value of EUR 250 million ($353 million) in milestones to Orexo, excluding royalties.
Bethesda, MD (Sept. 8)-Parenteral Drug Association (PDA) and Shanghai Institute for Food and Drug Safety (SIFDS) signed a memorandum of understanding on cooperation during the PDA/FDA Joint Regulatory Conference, establishing the SIFDS/PDA Shanghai Joint Development Center (SHJDC). The parties agree to provide support and collaborate on meetings, promotion, training and general administration. The first conference hosted by this joint venture will be held in May 2009 in Shanghai. Read Pharmaceutical Technology’s coverage of the 2008 PDA/FDA Joint Regulatory Conference on our blog.
St. Louis, MO (Sept. 4)-SAFC Pharma, a member of the Sigma-Aldrich Group, plans a $30-million expansion to its Madison, Wisconsin, facility. The expansion is designed to increase its capacity to produce commercial-scale high-potency active pharmaceutical ingredients (HPAPIs). The new 45,000-ft2 manufacturing facility will include development laboratories, a 150-L mini-processing plant, and two large-scale CGMP manufacturing suites with reactors up to 4000 L. Specially designed quality-control laboratories, a potent-compound packaging area and warehouse as well as office space will be featured in the building. Construction of the new plant is expected to be complete by year-end 2009.
Jerusalem (Sept. 4)-Teva Pharmaceutical Industries and Barr Pharmaceuticals (Montvale, NJ) announced that, as expected, each party received a request for additional information (commonly called a second request) from the US Federal Trade Commission in connection with Teva’s pending acquisition of Barr. The effect of the second request is to extend the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) waiting period until 30 days after the parties have substantially complied with the request, unless that period is terminated sooner by FTC. The companies continue to expect that the transaction will close in late 2008, following completion of the HSR clearance process, and other closing procedures. The merger plans were announced in July 2008.
Carlsbad, CA (Sept. 8)-Abingdon Life Sciences, a drug development services provider, appointed Charles H. Davis vice-president of regulatory science. Davis has more than 20 years of regulatory experience, and has brought both drug and biologic products to commercial launch in the fields of cardiac imaging, coronary angioplasty, oncology, gastroenterology, parenteral nutrition, ophthalmology and contraception.
Woodcliff Lake, NJ (Sept. 8)-Eisai Inc., a US pharmaceutical subsidiary of Eisai Co., Ltd., appointed Mary Ellen Sodano associate director of product safety, medical services, and Galo Vaca senior program manager of compliance and administration, IT quality. Sodano and Vaca are based in Eisai’s Woodcliff Lake, New Jersey, facility.
Redwood City, CA (Sept. 4)-Genelabs Technologies, a biopharmaceutical company, appointed Frederick W. Driscoll president, chief executive officer and as a member of its board of directors. Driscoll most recently served as the company’s chief financial officer and has been sharing CEO responsibilities with Irene A. Chow, PhD, the company’s executive chairman.
London (Sept. 8)-GlaxoSmithKline’s Executive Director and President of North American Pharmaceuticals, Chris Viehbacher, will stand down from the board on September 8, 2008, and will leave the company on December 1, 2008, to pursue another opportunity.
Waltham, MA (Sept. 4)-The biopharmaceutical company Synageva BioPharma appointed Sanj K. Patel as president and CEO. Sanj joins Synageva from Genzyme Therapeutics (Cambridge, MA). In conjunction with Patel’s appointment, Synageva has opened new corporate headquarters outside of Boston in Waltham, Massachusetts. The company maintains research and production operations in the greater Atlanta area where the company was originally founded under the name of Avigenics.
San Francisco, CA (Sept. 8)-The biopharmaceutical company Takeda San Francisco appointed Gregory Landes, PhD, vice-president of antibody research. Landes will be responsible for directing the discovery and preclinical development of therapeutic antibodies.
Fremont, CA (Sept. 8)-Zosano Pharma, a privately held pharmaceutical company focused on transdermal delivery technology, named Gail Schulze chair and CEO. The company appointed Don Brown as chief operating officer and president, John M. Vuko as executive vice-president and chief financial officer, Beth Anne Piper as vice-president of clinical development, and Stephen Worsley as vice-president of business development.