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Bristol-Myers Squibb (Princeton, NJ) and Allergan (Irvine, CA) announced a global agreement to develop and market AGN-209323, a Phase II-ready, orally administered small molecule in clinical development for neuropathic pain. Bristol-Myers Squibb will make an upfront payment of $40 million to Allergan and make payments as much as $373 million dependent on reaching development and regulatory milestones for the drug.
The US Food and Drug Administration completed its inspection of the manufacturing facility used by Cell Therapeutics (Seattle, WA) to produce pixantrone and found the site in compliance and acceptable for continued manufacturing of the drug.
Elanco (Greenfield, IN), the animal health division of Eli Lilly (Indianapolis, IN), announced that Lilly agreed to acquire the European rights to a portfolio of certain Pfizer animal-health products. The products, including vaccines, parasiticides, and feed additives, are used in both the production-animal and companion-animal markets.
The biotechnology company Exelixis (South San Francisco, CA) announced a restructuring to focus its resources on the development of late-stage compounds. The restructuring includes the elimination of 270 employees. Exelixis estimates that cash expenditures through 2011 will by reduced by approximately $90 million after restructuring.
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GlaxoSmithKline (London) dedicated a new production facility at its Nashik, India, site to manufacture albendazole. The new facility will produce an additional 300 million treatments of albendazole per year. Albendazole is part of a combination treatment used to combat lymphatic filariasis.
The biopharmaceutical company Humacyte (Marlborough, MA) and Xcellerex (Research Triangle Park, NC), which specializes in modular-biopharmaceutical manufacturing systems, announced a collaboration under which Xcellerex will develop a manufacturing process for Humacyte’s lead regenerative-medicine product. Xcellerex will provide development expertise and product manufacturing in exchange for manufacturing-development fees from Humacyte.
Biopharmaceutical company Inovio Biomedical (San Diego, CA), a developer of DNA vaccines and related delivery systems, launched a hand-held, cordless-electroporation device for delivering DNA vaccines. Inovio says its DNA vaccine-delivery systems can increase levels of gene expression of naked-DNA vaccines by 100-fold or more compared to delivery of naked-DNA vaccines via conventional injection alone.
Clinical research organization Kendle (Cincinnati, OH) received approval from the Indian government to develop an operations center within a special economic zone in the Ahmedabad—Gandhinagar Knowledge Corridor. The new unit is expected to be operational in April.
Lonza (Basel, Switzerland) signed an agreement to make Odyssey Thera’s (San Ramon, CA) protein-fragment, complementation-assay technology. Odyssey Thera granted to Lonza the option to certain exclusive global-technology licenses, and the companies have also initiated collaborative technology, product development, and marketing activities.
NextPharma Technologies (Surrey, UK), a contract provider of pharmaceutical development, manufacturing, cold-chain, and distribution services, announced it had invested EUR 2.4 million ($3.26 million) to upgrade its sterile vial area (SVA) near Brussels in Belgium. The upgraded SVA will be operational by the end of 2010 and will be for both solution and lyophilized vials.
Wacker (Munich, Germany) opened a new production facility for pharmaceutical proteins at its Jena, Germany, site. The expansion is part of an EUR 18-million ($24.5-million) investment at the Jena facility.
Biopharmaceutical company XenoPort (Santa Clara, CA) will eliminate about half of its workforce as part of a restructuring plan to focus resources on later-stage product candidates. XenoPort estimates that its cash expenses will be reduced by approximately $15.6 million after the restructuring.
Watson Pharmaceuticals (Morristown, NJ) expanded its product portfolio by acquiring the exclusive US rights to Columbia Laboratories’ (Livingston, NJ) bioadhesive progesterone gel products currently marketed under the trade names Crinone and Prochieve, for the indications of infertility and secondary amenorrhea. Watson, which will also acquire 11.2 million shares of Columbia common stock, will provide Columbia with an initial $47 million payment.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com
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FDA published the International Conference on Harmonization (ICH) S9 guideline as a guidance for industry Nonclinical Evaluation for Anticancer Pharmaceuticals. The guidance is meant to assist in the “design of an appropriate program of nonclinical studies for the development of anticancer pharmaceuticals” and provides information on nonclinical evaluations that support the development of clinical-trial pharmaceuticals aimed at treating advanced-stage cancer. ICH representatives adopted the guideline in October 2009.
The International Pharmaceutical Excipients Council (IPEC) officially launched the IPEC Federation last week in Cannes, France. The federation represents IPEC-Americas, IPEC-Europe, IPEC-Japan, and IPEC-China and will work to promote a unified voice for the use of excipients in pharmaceuticals. Patricia Rafidison of IPEC Europe has been named chair of the Federation. Janeen Skutnik of IPEC-Americas will serve as vice-chair. The next meeting of the IPEC Federation will be held in Tallin (Estonia) in June 2010.
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The director of US Food and Drug Administration’s Office of Generic Drugs, Gary Buehler, is moving to the agency's Office of Pharmaceutical Science (OPS), which oversees the generic-drug division, according to the Wall Street Journal. The deputy director of OPS, Keith Webber, will take over Buehler's job in the interim.
Aceto (Lake Success, NY), a fine-chemicals distributor, promoted Douglas Roth to senior vice-president, chief administrative officer, and chief financial officer.
Cortegra (Fairfield, NJ), a healthcare-packaging company, appointed John Moyer as quality systems manager. He will be responsible for overseeing quality departments throughout Cortegra and will act as a liaison with the Menasha Folding Carton Group in North Carolina. |
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