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 Peristaltic pump enhances production
Bosch Packaging Technology (Minneapolis) has introduced a new peristaltic pump that fills syringes at production scale. The pump is completely made of stainless steel and uses a disposable tubing system to eliminate the risk of cross-contamination. Personnel can operate the compact device with one hand, thus the machine is appropriate for use in small spaces.
Unlike competing devices, the rollers of the new Bosch pump have a half-pitch
offset, which reduces strain on the tubing. The reduction in strain is intended to enhance production efficiency and the service life of the disposable tubing. In addition, the alignment of the pumps reduces vibration and minimizes the displacement of liquid. This feature helps maintain product flow and enables the pump to be 20% more accurate than competing models on the market, according to Tom McDaniel, the company’s president. Bosch can modify the pump to allow it to fill small volumes.
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| Astellas Pharma (Tokyo), a global pharmaceutical company, will acquire OSI Pharmaceuticals, (Melville, NY), a biotechnology company. Under the terms of the merger agreement, Astellas will increase its offer price to $57.50 per share, which represents a premium of 55% to the closing price for OSI’s shares of $37.02 on February 26, 2010, the last trading day before the announcement by Astellas of its tender offer. The boards of directors of both companies have unanimously approved the combination. The all-cash transaction is valued at $4 billion on a fully diluted basis. The tender offer expires on June 2, 2010.
Biopharmaceutical company Bavarian Nordic (Kvistgård, Denmark) initiated delivery of its smallpox vaccine Imvamune to the US Strategic National Stockpile. The delivery is part of the company’s contract with the US government to deliver 20 million doses of Imvamune.
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Colorado State University (CSU, Fort Collins, CO) opened a new $53-million vaccine research center. The 72,000-ft2 Research Innovation Center combines business office space, university researcher offices, and bioscience laboratories and was designed to build university partnerships with CSU startup businesses and existing businesses. Research will focus on diseases such as West Nile virus, drug-resistant tuberculosis, yellow fever, dengue fever, hantavirus, plague, and tularemia. The Research Innovation Center is an addition to the existing Infectious Disease Research Center, which also houses the 38,000-ft2 Rocky Mountain Regional Biocontainment Laboratory.
Eisai Inc. (Woodcliff Lake, NJ), a US subsidiary of Eisai Co., Ltd. (Tokyo), established a Canadian subsidiary, Eisai Limited. As a wholly owned subsidiary of Eisai Inc., Eisai Limited will be based in Mississauga, Ontario.
GlaxoSmithKline (GSK, London) formed a strategic alliance with Dong-A Pharmaceuticals (Seoul, South Korea), the largest pharmaceutical company in South Korea. GSK will acquire a 9.9% minority equity shareholding in Dong-A for £73.9 million ($105.6 million). The alliance will copromote selected GSK and Dong-A pharmaceutical products for use in primary care, and the companies will share profits above pre-agreed baselines.
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Halozyme Therapeutics (San Diego, CA) initiated a voluntary recall of certain lots of Hylenex (hyaluronidase human injection). Halozyme and Baxter (Deerfield, IL) confirmed the presence of small flake-like glass particles in a limited number of vials of Hylenex product at the Baxter manufacturing facility. The companies said in a press release that this action is being taken as a precautionary measure in order to ensure patient safety, and that no medical events associated with the noncompliant Hylenex product have been reported. Halozyme also announced the delivery of a notice of breach to Baxter due to Baxter's failure to provide Hylenex in accordance with the terms of the parties' existing development and supply contracts.
Contract manufacturer Kemwell (Bangalore, India) opened its second pharmaceutical production center in Sweden. The Uppsala facility doubles the company’s production area for manufacturing tablets, suppositories and capsules and will allow the company to expand into other product types. Kemwell expects production in the new facility to start during 2010.
Lonza Group (Basel) will acquire MODA Technology Partners (Wayne, PA), a software company focused on paperless quality control systems. Lonza will include MODA’s technology in the Rapid Testing Solutions platform of its Bioscience division, according to a press release. MODA’s platform includes automated data collection, on-demand analytics, and workflow visualization of regulated manufacturing processes, including environmental monitoring, utility testing, and product testing. The acquisition is expected to close during the second quarter of 2010.
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Pfizer (New York) signed a five-year drug research pact with Washington University School of Medicine in St. Louis, under which Pfizer grants access to information regarding more than 500 pharmaceuticals and pharmaceutical candidates. In addition to the access to research data, Pfizer will provide $22.5 million in a partnership that focuses on discovering new uses for existing compounds, according to a company press release.
Strides Arcolab (Bangalore, India) and Pfizer (New York) signed two licensing and supply agreements. Under the first agreement, Strides will license and supply up to 38 generic oncology products to Pfizer for markets in the European Union, Canada, Australia, New Zealand, Japan, and Korea. The second agreement covers niche sterile injectables for the US market. Pfizer’s Established Products Business Unit will commercialize the finished dosage form products. The financial terms of both agreements were not disclosed. The companies announced in January a deal that would provide 40 generic products in the United States, and the new agreement extends the total number of products to 45 globally.
University College Cork (UCC, Cork, Ireland) and Almac (Craigavon, UK), a contract research and manufacturing organization, will collaborate in the field of solid-state chemistry. The partnership, which is principally funded by the Science Foundation Ireland, focuses on developing 3D molecular structures from powder X-ray data. The research will be done by the pharmaceutical solids group of the Analytical and Biological Chemistry Research Facility at UCC and the Almac physical sciences group.
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 stated on May 14, 2010, that US healthcare practitioners can resume the use of Rotarix (Rotavirus Vaccine, Live, Oral) used to treat the disease in infants, effective immediately. This action supersedes the agency's March 22 recommendation, which called for healthcare providers to halt its use. FDA has determined that the presence of porcine circovirus type 1 (PCV-1) in the vaccine poses no safety risk.
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| Contract research organization Bioanalytical Systems (West Lafayette, IN) named Anthony S. Chilton president and chief executive officer. Chilton served as chief operating officer since December 2008 and interim president since Jan. 27, 2010.
Specialty pharmaceutical company Cobalis (Irvine, CA) appointed Martin Marion chief executive officer. Marion formerly was chief marketing officer for Cobalis from 2003 through 2006.
GlaxoSmithKline (London) appointed Patrick Vallance senior vice-president of Medicines Discovery and Development and as a member of the company’s corporate executive team, effective July 1, 2010.
President Obama intends to appoint Harold Varmus director of the National Cancer Institute. Varmus is a former director of the National Institutes of Health, a corecipient of the 1989 Nobel Prize in Physiology or Medicine for studies of the genetic basis of cancer, recent cochair of President Obama's Council of Advisors on Science and Technology, and has served as president of Memorial Sloan Kettering Cancer Center in New York City since January 2000.
Specialty pharmaceutical company Ricerca Biosciences (Concord, OH), a contract research organization, named Michael E. Placke senior vice-president and general manager, effective May 24, 2010. Placke will be responsible for the operations and business performance of Ricerca’s Concord, Ohio, site and will work with the executive team to integrate the Concord services with the recently acquired services in Lyon, France, and the pharmacology services in Bothell, Washington, and Taipei.
David Julien will retire as president of global supply chain for Sigma-Aldrich (St. Louis, MO), effective June 30, 2010. Joseph Porwoll was promoted to vice-president of global supply chain and will assume Julien's responsibilities.
WIL Research Laboratories (Fairfield, NJ), a contract research organization, appointed David Spaight chief executive officer and named him to its board of directors. |
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Novel Excipients
To encourage innovation in excipients, do you think FDA should review novel
excipients outside of a new drug application?
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