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 Metal detector offers stability and accuracy
The Insight PH range of pharmaceutical metal detectors from Lock Inspection Systems (Fitchburg, MA) incorporates digital filtering that allows the units to ignore vibration and other disturbances. The filtering enables the detectors to operate at high frequencies, achieve great sensitivity, and reduce false rejects. The products’ reject system has a quick-disconnect design that makes it easy to disassemble and clean.
In addition, the detectors’ software menus have been redesigned to make it easier for operators to perform functions such as adjusting the metal detectors. The menus help reduce operators’ reliance on service engineers, says Mark D’Onofrio, president of Lock Inspection Systems.
The Insight PH detectors include communications options such as Ethernet connections, USB ports, and wireless capability. The detectors are supplied with Optx software that lets users log inspection data, track contaminants, download reports, and ensure that metal detectors are operating properly.
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The Almac Group (Craigavon, UK) completed a 67,000-ft2 expansion to its Durham, North Carolina, facility, which now houses both the Clinical Services and Diagnostics Divisions. The expansion includes a 30,000-ft2 warehouse complete with two new loading docks, and has greatly increased storage capacity for clinical supplies with an additional 3000 pallet locations.
Emergent BioSolutions (Rockville, MD), acquired a 55,000-ft2 manufacturing facility from MdBio Foundation, and the land on which the facility stands from the city of Baltimore, Maryland, for a total purchase price of $8.2 million. The Baltimore-based facility, previously operated as a US Food and Drug Administration-licensed facility used by a contract manufacturing organization to produce a number of FDA-approved products, according to a company press release. The MdBio Foundation is an organization that provides support to Maryland’s bioscience community.
Genta (Berkeley Heights, NJ) will restructure, reduce its workforce, and re-align its clinical-development priorities. The workforce was reduced by approximately 30%, which is estimated to reduce payroll costs by approximately 25%. The company estimates that reduced expenses will yield sufficient cash to continue operations into the second quarter of 2010, according to a company press release.
Genzyme (Cambridge, MA) reported that it will not pursue clinical development of its advanced phosphate binder (APB) based on the results of a Phase II-III study. The company said in a press release that the trial met its primary endpoint, which was to show that the APB lowered phosphate levels effectively compared to placebo. However, the APB did not show a significant improvement in phosphate lowering compared to Genzyme’s Renvela (sevelamer carbonate), a therapy for controlling serum phosphorus in patients with chronic kidney disease on dialysis.
Merck KGaA (Darmstadt, Germany) will establish a global research and development (R&D) center in Beijing, China, in a move designed to strengthen its global capabilities of its Merck Serono division, according to a company press release. Merck is planning to invest more than EUR 150 million ($224 million) and create more than 200 jobs over the next four years to set up the China R&D center, which will become of the key R&D hubs for Merck Serono.
Novartis (Basel) opened its next-generation flu vaccine plant in Holly Hill, North Carolina, on Nov. 24, 2009. The facility will use batches of dog cells to generate influenza vaccine instead of the chicken eggs widely used now according to a Reuters report, which stated that this method can be scaled up more quickly.
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Pfizer (New York) and Drugs for Neglected Diseases initiative (DNDi, Geneva) will collaborate to develop advancements against the neglected tropical diseases human African trypanosomiasis (HAT), visceral leishmaniasis (VL) and Chagas disease. Under the agreement, DNDi will have access to the Pfizer library of novel chemical entities, in order to screen it for compounds that have the potential to be developed into new treatments. “We are expanding our commitment to the fight against tropical diseases by joining forces with DNDi by sharing our collection of chemical compounds and the knowledge and expertise associated with these chemical entities,” said Dr. Manos Perros, vice-president and chief scientific officer of antivirals research, Pfizer Global Research & Development.
In a separate announcement, Pfizer said it submitted pediatric data for Lipitor (atorvastatin) to the European Medicines Agency (EMEA). Pfizer also developed a chewable form of Lipitor, including a pediatric-appropriate 5-mg dose, which is part of this submission. Pfizer’s press release stated that the submission reflects a European Union initiative encouraging research, development, and availability of medicines for children.
The contract research organization PPD (Wilmington, NC) agreed to acquire BioDuro (San Diego, CA), a drug-discovery outsourcing company that operates a 110,000-ft2 laboratory in Beijing. After the acquisition closes, PPD and BioDuro will perform a broad range of research and development services for large pharmaceutical clients from early stage through Phase IV, according to a company press release.
In a separate announcement, PPD said it formed a development and commercialization agreement with Janssen Pharmaceutica (Beerse, Belgium), for two Phase II-ready therapeutic compounds: one to treat diarrhea-predominant irritable bowel syndrome (IBS-d) and the other to treat skin and respiratory infections. PPD will advance the compounds through Phase-II development, and Janssen will have the option to resume development and commercialization of each compound at the end of Phase II. PPD will receive up to $330 million in milestones and royalties on sales of the compounds if approved for marketing.
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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 ptpress@advanstar.com
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The European Medicines Agency (EMEA) released a
statement reaffirming the efficacy and safety of the influenza A (H1N1) vaccines Focetria (Novartis, Basel) and Pandemrix (GlaxoSmithKline, London) after the agency had comducted further data review. EMEA indicated that a single dose of these vaccines is able to trigger an immune response against H1N1 in adults aged 18 and 60 and in children and adolescents (from the age of 9 years for Focetria, and from 10 years for Pandemrix). Pandemrix may also be used as a single dose in the elderly. For younger children and people with compromised immune systems, EMEA recommends that two doses be given for an adequate immune response. EMEA said that data on Celvapan (Baxter, Deerfield, IL) are still being assessed. The agency also stated that Focetria and Pandemrix can be co-administered with nonadjuvanted seasonal flu vaccines.
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Depomed (Menlo Park, CA), a specialty pharmaceutical company, promoted William Callahan to vice-president of operations. Callahan joined Depomed in 2002 and most recently held the position of senior director of operations.
Inimex Pharmaceuticals (Burnaby, Canada), a biopharmaceutical company, appointed Michael J. Abrams president and CEO. John R. North, who led the early development of Inimex' drug technology and served as executive vice-president of research and development in 2004, and then president and CEO from 2005 to 2009, will assume a new role as chief operating officer.
Patheon (Toronto), a provider of drug-development and manufacturing services, named Francisco R. Negron vice-president and general manager of its Puerto Rico operations. Negron will be based at the company's Manati site.
Peter Thompson, president, CEO, and chairman of the board of directors, and co-founder of Trubion Pharmaceuticals (Seattle, WA), has retired from the company to pursue other interests. Thompson will advise the company on various matters as a consultant. Steven Gillis, former lead director of Trubion's board of directors, has been appointed executive chairman of the board and acting president. Trubion will initiate a formal search for a new CEO.
XOMA (Berkeley, CA), a company focused on the discovery and development of therapeutic antibodies, appointed James R. Neal vice-president of business development. Neal’s responsibilities include overseeing XOMA's business development strategy, executing key licensing initiatives, and building XOMA's proprietary therapeutic pipeline and biodefense programs.
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