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 Roller compactor provides efficiency and flexibility
The Fitzpatrick Company (Elmhurst, IL) designed its CCS 1025 contained Chilsonator system to process various products efficiently. The system's high-speed vertical precompression feed screw provides a uniform downward force on the product, thus helping to feed it to the nip region of the rolls. The vertical orientation and speed of the screw are intended to ensure that product is distributed across the face of the rolls evenly. The feed screw's vertical orientation provides a path upward for air that is aspirated from the process, thus creating an efficient deaeration system. The CCS 1025 system is designed to positively seal the product inside the process areas. Operators can disassemble the device easily for cleaning and reconfiguration. The system includes a wash-in-place to simplify cleaning. The CCS 1025 machine's roll and size-reduction housing is designed as an integrated unit to minimize headroom requirements. Users can install the device in wall or as a freestanding unit.
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The US Food and Drug Administration approved Amgen's (Thousand Oaks, CA) Xgeva (denosumab), a drug designed to help prevent skeletal-related events (SREs) in patients with bone metastases from solid tumors. Xgeva is a monoclonal antibody that targets a protein involved in cancer-related bone destruction called human RANKL.
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AstraZeneca (London) said last week that it commenced a review of its strategic options for Astra Tech, a business unit that develops, manufactures, and markets dental implants and healthcare (urological and surgical) products.
Baxter International (Deerfield, IL) agreed to acquire all of the hemophilia-related assets of Archemix (Cambridge, MA), a biopharmaceutical company. Baxter also entered into an exclusive license agreement for certain related intellectual property assets. The lead product associated with the arrangement is ARC19499, a synthetic, subcutaneously-administered hemophilia therapy currently in a Phase I clinical trial in the UK.
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Contract Manufacturing and Packaging for Solid Oral Dosage
Ropack, a leader in packaging solutions for the pharmaceutical, biopharmaceutical and nutraceutical industries, now provides the technology and expertise for stickpack packaging of solid oral dosage in a low relative humidity and temperature-controlled environment. Stickpacks slim, tube-shaped packets the size of a stick of gum offer impressive benefits: fill accuracy, portability, product differentiation, reduction in paper and foil usage, product differentiation and ideal sample option.
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Bristol-Myers Squibb (New York) and Pfizer (New York) discontinued their Phase III clinical trial in patients with recent acute coronary syndrome (ACS) treated with apixaban or placebo in addition to mono or dual antiplatelet therapy. The study was stopped early based on the recommendation of an independent Data Monitoring Committee after evidence showed an increase in bleeding among patients using apixaban.
Healthcare services company Cardinal Health (Dublin, OH) agreed to acquire Kinray (Whitestone, NY), a pharmaceutical distributor serving the New York metropolitan area, for $1.3 billion in cash. The transaction will expand Cardinal's ability to serve retail independent pharmacies in the northeastern United States.
Genzyme (Cambridge, MA) agreed to sell its diagnostic-product business to Sekisui Chemical for $265 million. Sekisui agreed to offer employment to the unit's approximately 575 employees, and plans to maintain operations in all of the business's current locations. The companies expect the sale to close by the end of the year.
Laboratory Corporation of America Holdings (LabCorp, Burlington, NC) reported last week that it had received clearance from the Federal Trade Commission for its $925-million acquisition of Genzyme Genetics from Genzyme (Cambridge, MA). Genzyme had announced its agreement to sell it genetic-testing business to LabCorp in September 2010. Genyzme Genetics provides reproductive, maternal fetal medicine, and oncology testing services.
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Management of Water/Cleaning Validation
From inspections of the water used in drug manufacture to cleaning validation, Shimadzu's TOC analyzers are ideal for the management of the total amount of organic carbon in drug manufacturing processes. Multiple oxidation methods (combustion catalytic and wet chemical) are available, and they can be used with the swab direct combustion method when combined with a solid sample combustion unit.
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Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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Ablexis (San Francisco), a biotechnology company developing the AlivaMab Mouse, a next-generation platform for antibody drug discovery, appointed Sean Stevens as vice-president of research. Stevens will report to Larry L. Green, the company's CEO.
C3 Jian (Los Angeles), a biotechnology company, appointed Todd Patrick as its president and CEO. The company's former CEO, Max Anderson, will remain a special advisor and a member of the company's board of directors.
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CytomX Therapeutics (Santa Barbara, CA), a biotechnology company focused on the development of proteolytically-activated antibodies, appointed Mark Rolfe as its chief scientific officer and Henry Lowman as vice-president of research.
Omeros (Seattle), a biopharmaceutical company focused on treatments for inflammation and disorders of the central nervous system, appointed Kenneth M. Ferguson vice-president of development.
Prolong Pharmaceuticals (South Plainfield, NJ) named Richard Prince vice-president of quality and Andy Burger vice-president of information services. The company also recently announced $30 million in funding from a private investment group.
Topaz Pharmaceuticals (Horsham, PA), a specialty pharmaceutical company, appointed Bob Radie president and CEO. Thomas Beck, who was serving as interim CEO, will resume his role as chief medical officer of the company.
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Interphex
Thousands of pharmaceutical, biologic, generic, and contract services professionals gather annually at INTERPHEX (March 29-31, 2011, Javits Convention Center, New York City) to see new products, network, and learn about emerging trends surrounding drug manufacturing. At INTERPHEX 2011, you'll find the solutions and education you need to ensure quality, improve efficiency, and solve your manufacturing and supply chain problems. Register for a free exhibit hall pass at
 www.INTERPHEX.com
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Trade Show Attendance
Did you attend more industry trade shows/conferences this year compared with recent years?
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