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FDA and EMA Seek Candidates for GMP Inspection Pilot
The US Food and Drug Administration and European Medicines Agency are looking for drug manufacturing companies to participate in their joint good manufacturing practice inspection pilot program. 
SOCMA Applauds Tariff Law
The Society of Chemical Manufacturers and Affiliates welcomed the signing of the United States Manufacturing Enhancement Act of 2010, also known as the Miscellaneous Tariff Bill, into law by President Barack Obama on Aug. 11, 2010.
EU Generic Applications Down in 2010
Recent figures published by EMA show a marked slowdown in the number of the generic-drug marketing applications filed and finalized thus far this year.
AstraZeneca Workers to Strike
Members of a UK trade union working at AstraZeneca have voted to strike following cuts in pension benefits, according to a statement released by the union.
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 Discharger facilitates thorough cleaning
The Model T11 Bulk Bag Super Discharger from Spiroflow Systems (Monroe, NC) can be disassembled by two employees without tools and without the involvement of an engineer. The company created the discharger without pockets that could entrap dirt and dust. The unit’s design thus facilitates thorough cleaning and helps prevent microbiological growth and cross-contamination.
The product’s discharger frame comprises Z sections folded from stainless-steel sheet material. The smooth frame features easily cleaned radii and is available in bead-blast and mirror-polished finishes.
The device’s bag-lifting frame holds bags in place during discharge. Bag support arms are spring-loaded to stretch the bag and ensure the complete discharge of contents. In addition, a dust cabinet contains all ingredients during discharge. The bulk-bag neck is clamped to the inlet of the transfer hopper within the dust cabinet by a pharmaceutical quality, dust-tight seal that can be removed, cleaned, reassembled, and replaced. |
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Aesica (Newcastle upon Tyne, UK), a contract services provider, will invest £3 million ($4.7 million) in a new high-containment manufacturing facility at its Queenborough, UK, site.The new high-containment unit will include suites for granulation, tableting, and blister packing. The new facility will also include security measures that will ensure it can manufacture Schedule II controlled drugs such as opiates. The company expects that the facility will be completed by May 2011.
AMRI (Albany, NY) received the Pfizer Route Design Innovation Award, which recognizes innovative ideas for process chemistry and large-scale active pharmaceutical ingredient production. Pfizer (New York) will present the company with the award at the AMRI 2010 Integrated Drug Discovery Symposium to be held in Albany, New York, on Oct. 13–14. AMRI will also receive an honorarium for its win.
BioMarin Pharmaceutical (Novato, CA) acquired ZyStor Therapeutics (Milwaukee, WI), a biotechnology company developing enzyme replacement therapies for the treatment of lysosomal-storage disorders. ZyStor's lead product candidate is ZC-701, a fusion of insulin-like growth factor 2 and alpha glucosidase (IGF2-GAA) in development for Pompe disease. Under the terms of the agreement, BioMarin acquired ZyStor for $22 million upfront and up to an additional $93 million if certain milestones are achieved. FDA has accepted an investigational new drug application for ZC-701. Investigational product has been manufactured, and a clinical study is expected to start in early 2011.
Eli Lilly (Indianapolis) will halt development of semagacestat, a gamma secretase inhibitor being studied as a potential treatment for Alzheimer's disease. Eli Lilly said in a press release that it made the decision because preliminary results from two Phase III studies showed it did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. The company stated that the decision on semagacestat does not affect the ongoing clinical trials of solanezumab, Eli Lilly's other compound in Phase III trials as a potential Alzheimer's treatment.
In other Eli Lilly news, the company announced that the US District Court for the District of New Jersey has ruled against Eli Lilly in its patent litigation for Strattera (atomoxetine), the company’s ADHD medication. In the case of Eli Lilly and Company v. Actavis Elizabeth LLC, et al., the court ruled that Lilly's '590 patent, or method-of-use patent, for Strattera is invalid. The patent had been set to expire in May 2017. Robert A. Armitage, senior vice-president and general counsel for Lilly, said in a press statement that the company will appeal the court’s decision.
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Biopharmaceutical company Emergent BioSolutions (Rockville, MD) agreed to acquire Trubion Pharmaceuticals (Seattle), also a biopharmaceutical company, for $96.8 million in cash and stock, and, depending on certain milestones, up to a total of $135.5 million. The companies expect the acquisition of Trubion to close in the fourth quarter of 2010.
Selecta Biosciences (Watertown, MA), a biopharmaceutical company, was awarded a $3-million grant from the National Institute on Drug Abuse (NIDA), an institute within the US National Institutes of Health (NIH), to develop a therapeutic nicotine vaccine for the treatment of smoking cessation and relapse prevention. The grant will support the advancing of a clinical-drug candidate from Selecta's pipeline for a nicotine vaccine from preclinical through early clinical evaluation.
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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Alexza Pharmaceuticals, a pharmaceutical company focused on central nervous system conditions, appointed Darl Moreland vice-president of quality. He will have responsibility for quality assurance, quality control, and quality system regulatory compliance.
Amarin (Dublin), a biopharmaceutical company, appointed Colin W. Stewart president, CEO, and a member of the company's board of directors. Declan Doogan, who has been serving as the company's interim CEO, will continue to support the company as chief medical officer.
Human Genome Sciences (HGS, Rockville, MD), a biotechnology company, appointed Tuomo Pätsi vice-president of HGS Europe. Pätsi will report to Barry A. Labinger, executive vice-president and chief commercial officer.
Ricerca Biosciences (Concord, OH), a contract research organization, appointed Carlos Martínez Manchado to its analytical chemistry department.
Selecta Biosciences (Watertown, MA), a biopharmaceutical company, appointed Werner Cautreels president, CEO, and a member company's board of directors. Cautreels previously served as CEO and global head of R&D at Solvay Pharmaceuticals until its acquisition by Abbott Laboratories (Abbott Park, Illinois) in February 2010.
SkyePharma (London) appointed Axel Müller CEO, effective Aug. 23, 2010. Müller will be based principally in Muttenz, Switzerland, where SkyePharma has its main research and development activities. |
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While visiting China last week, US Food and Drug Administration Commissioner Margaret Hamburg told the Associated Press that China is improving its oversight of exporters and that the two countries are pursuing a common agenda to improve manufacturing practices and supply-chain regulation. Chinese drug manufacturers and suppliers have been tied to numerous instances of contamination and adulteration in food and drug products during the past few years. FDA has been operating three offices in China (Shanghai, Beijing, and Guangzhou) since November 2008 to assist the country’s State Food and Drug Administration with inspections and training.
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Single-Use Technologies
Does your company currently use single-use technology for pharma/biopharma manufacturing?
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