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Pfizer Establishes Rare-Disease Research Unit
Pfizer created a new research unit within its Worldwide Research and Development division that will focus on rare diseases. 
ICH Meets in Estonia
The steering committee and expert working groups of the International Conference on Harmonizaton met in Estonia to discuss progress on the ICH quality trio guidelines and other harmonization proposals.
Pharma Companies Form a Clinical Information-Sharing Consortium
The Critical Path Institute announced the formation of the Coalition Against Major Diseases to share information on clinical trials for treatments for neurodegenerative diseases.
Industry Urged to Fight Drug Resistance
The world is rapidly losing its ability to treat malaria, HIV, and tuberculosis, as well as more common diseases because of drug resistance, according to a report from the Center for Global Development. |
 Encapsulator combines accuracy and high output
ACG’s (South Plainfield, NJ) AF-200(T) encapsulator is designed to combine microdosing capabilities and output speeds as high as 200,000 capsules/h. The machine fills doses as low as 15 mg with an accuracy of ±2 mg. The unit’s dosing disc is customized based on formulation characteristics such as bulk density, net content, and slug-forming ability so that the encapsulator achieves the desired fill weight with high accuracy.
The device’s feeding design handles difficult formulations (e.g., loose, dusty, and heat-sensitive powders) and reduces dusting to as little as 1%. The feeding design thus enhances operator safety and reduces mechanical changeover time. In addition, the unit’s proprietary Zero Relative Motion technology helps minimize dust segregation to 1% or less. Users control the AF-200(T) machine with a touch screen and adjust its speed with the main panel. The encapsulator is appropriate for facilities with limited floor space.
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| Almac (Craigavon, UK), a contract services organization, completed a £2-million ($3-million) expansion of its Craigavon, United Kingdom, headquarters. The new 5500-ft2 facility includes dispensing and blending suites to accommodate 2.5 ton batches, a sachet filling and packaging line, and storage and wash areas.
Contract services provider AMRI (Albany, NY) acquired the contract manufacturer Hyaluron (Burlington, MA) for approximately $27 million. AMRI gains Hyaluron’s services in current good manufacturing practice (CGMP) manufacturing and sterile filling of parenteral drugs. In a separate announcement, AMRI said that it received approval for a preliminary injunction that prevents Dr. Reddy's Laboratories (Hyderabad, Andhra Pradesh, India) from distributing generic versions of Allegra-D 24 Hour (fexofenadine HCl 180 mg and pseudoephedrine HCl 240 mg) Extended-Release Tablets in the Unites States.
Bristol-Myers Squibb (Princeton, NJ) signed agreements with Icon (Dublin) and Parexel (Waltham, MA), both providers of clinical-development services, for support of the company’s clinical-development program. Icon and Parexel will provide support for the execution of BMS’s clinical studies for its full development pipeline during the next three years.
Capsugel (Peapack, NJ), a division of Pfizer (New York) and a provider of drug-delivery and dosage-form products and services, received FDA approval for its facility in Ploërmel, France, to manufacture naproxcinod. FDA’s inspection of Capsugel’s facility included review of Capsugel’s Licaps drug-delivery system for liquid filled naproxcinod capsules.
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CPL Biologicals (CPLB), a joint venture of Cadila Pharmaceuticals (Ahmedabad, Gujarat, India), and Novavax (Rockville, MD), a developer of vaccines, completed construction of its vaccine facility in Dholka, Gujarat, India. The new facility can produce up to 60 million doses of vaccines every year. CPLB plans to produce seasonal and pandemic flu vaccines at the facility based on Novavax’s virus-like particle technology, which enables the development and production of vaccines without the use of live virus.
DSM BioSolutions (Heerlen, The Netherlands) entered into an agreement with Novacta Biosystems (Welwyn Garden City, UK), a biotechnology company, for the process development and CGMP production of Novacta’s C. difficile molecule, a class of lantibiotic compounds. DSM completed the process development and commenced CGMP manufacturing at its microbial fermentation biotech facility located in Capua, Italy. The product will initially be used for preclinical and Phase I clinical trials.
Evonik Degussa (Parsippany, NJ), a manufacturer of excipients, and Emerson Resources (Norristown, PA), a supplier of services and coating ingredients, signed a global distribution agreement for PlasACRYL T20. Effective July 1, 2010, Emerson Resources will continue to manufacture PlasACRYL T20, and Pharma Polymers, a business line of Evonik Degussa, will assume responsibility for the global distribution.
GlaxoSmithKline (GSK, London) announced that it has acquired Laboratorios Phoenix (Buenos Aires, Argentina), a pharmaceutical company, for approximately $253 million cash. Under the terms of the transaction, GSK will gain full ownership of Phoenix.
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Expansion of Vetter Development Service (VDS)
The North American market is critical to Vetter’s strategic global growth as nearly half of its client base is already located here. In order to maximize on this opportunity, Vetter has decided to create a facility, its first outside of Germany, at the Illinois Science + Technology Park in suburban Chicago. The facility, which focuses on preclinical to phase II clinical batch projects, is an expansion of Vetter Development Service. With significant progress already having been made, the facility is scheduled to be operational by beginning of the fourth quarter 2010.
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Human Genome Sciences (Rockville, MD), a biotechnology company, received preliminary written feedback from the US Food and Drug Administration regarding the company’s biologics license application (BLA) seeking approval in the United States to market 900-mcg Zalbin (albinterferon alfa-2b) dosed every two weeks for the treatment of chronic hepatitis C. FDA has expressed concerns regarding the risk benefit assessment of Zalbin dosed at 900 mcg every two weeks. Although the BLA review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely.
Biotechnology company Myriad Pharmaceuticals (Salt Lake City, UT) announced restructuring initiatives that include: the expansion of the Azixa, an anticancer therapy, clinical program; the further advancement of the company's orally bioavailable Hsp90 inhibitor, MPC-3100; the designation of MPC-9528, a Nampt inhibitor, as an investigational-new-drug candidate; the suspension of its HIV maturation program; and a reduction in workforce. The company has reduced its headcount by 21 employees. In April, the company’s shareholders approved a name change of the company from Myriad Pharmaceuticals to Myrexis. This change is expected to be effected on or about July 1, 2010.
Patheon (Research Triangle Park, NC), a provider of drug-development and manufacturing services, expanded its contract manufacturing agreement with Merck & Co. (Whitehouse Station, NJ). Patheon’s projects and services will be delivered to Merck from eight of Patheon's global facilities, according to a company press release.
Sanofi Pasteur (Lyon, France), the vaccines division of sanofi-aventis (Paris) signed a collaboration agreement with Vivalis (Nantes, France) for the discovery and development of fully human monoclonal antibodies against several infectious diseases. Sanofi Pasteur will use Vivalis’s platform for the discovery of fully human monoclonal antibodies targeting clinically significant infectious diseases and will obtain worldwide exclusive development and commercialization rights for the discovered antibodies.
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Xcellerex (Marlborough, MA), a provider of biomanufacturing services and products, began construction of a CGMP FlexFactory biomanufacturing facility at its headquarters in Marlborough, Massachusetts. The plant will support Xcellerex’s contract manufacturing operations and will feature 2000-L Xcellerex XDR single-use bioreactors and modular single-use downstream unit operations through bulk product. The company expects construction to be completed in September 2010.
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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Catalent Pharma Solutions (Somerset, NJ), a provider of development, manufacturing, and packaging services, appointed David Heyens president of softgel technologies and promoted Ian Muir to president of modified-release technologies. Thomas Stuart, the current head of the oral-technologies business, will leave the company after assisting with key transition activities during the next several months. Additionally, Barry Russell will be responsible for the sterile technologies business as well as his current role as head of packaging services and will become president for both businesses. Will Downie will no longer serve as president of sterile technologies and will focus his attention to his role as senior vice-president of global sales and marketing.
Genmab (Copenhagen, Denmark), a biotechnology company, cofounder Lisa N. Drakeman retired from her positions as CEO and member of the board of directors. Jan G.J. van de Winkel, the company's former president of research and development and chief scientific officer, will assume the CEO position.
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Biopharmaceutical company Gilead Sciences (Foster City, CA) appointed John G. McHutchison senior vice-president of liver-disease therapeutics. McHutchison will report to Norbert W. Bischofberger, executive vice-president of research and development and chief scientific officer.
David Van Vliet, interim president and interim CEO of KV Pharmaceutical (St. Louis, MO), a specialty pharmaceutical company, is no longer with the company. The board of directors appointed Gregory J. Divis to act as the new interim president and interim CEO.
Pro-Pharmaceuticals (Newton, MA), a pharmaceutical company, named Peter G. Traber acting chief medical officer. Traber will oversee the overall FDA approval process and will lead the FDA Phase III colorectal cancer trial for Davanat, a polysaccharide polymer that targets and inhibits the function of Galectin receptors, which play important enabling roles in cancer.
Novavax (Rockville, MD), a devloper of vaccines, appointed John W. Madsen head of process and manufacturing operations and Steven Pincus head of analytical and quality operations. They will report to Novavax’s CEO, Rahul Singhvi. |
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The European Medicines Agency (EMA) and the European Monitoring Centre for Drugs and Drug Addiction agreed to a working arrangment on June 14, 2010, as part of EMA’s initiative to “cooperate with other European Union bodies for early identification and management of potential conflicts over scientific opinions,” according to an agency press release. The agreement includes fostering cooperation between the two agencies, including sharing information and reports on new psychoactive substances and any misuse of these products.
According to various Chinese media reports, on June 13, 2010, the deputy head of the China State Food and Drug Administration (SFDA), Zhang Jingli, was fired for disciplinary violations. In 2007, the then SFDA Chief Zheng Xiaoyu was executed after an investigation showed that he approved unsafe drugs, which ultimately led to the deaths of some consumers, in exchange for money. An investigation on Zhang is being conducted. |
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Expanding FDA’s Power
US House Oversight and Government Reform Committee Chairman Edolphus Towns intends to introduce legislation that would give FDA mandatory recall authority and the power to halt drug production. Should FDA have this authority?
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View the poll archive. |
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