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Aptuit, AstraZeneca, Corautus, FDA, more
Greenwich, CT (Feb. 20)-Aptuit, Inc. (www.aptuit.com) announced plans to invest $100 million in capital projects to expand capacity, improve operating efficiency, and further align its global operations. The announcement follows Aptuit's recent acquistitions of SSCI and EaglePicher Pharmaceutical Services.
London (Feb. 20)-AstraZeneca (www.astrazeneca.com) plans to cut 700 jobs, more than a quarter of the workforce at its plant in Macclesfield, Cheshire. The plant employs a total of 2500 workers. The staff cuts are part of AstraZeneca's efficiency drive, which will cut 3000 jobs worldwide by 2010.
Atlanta, GA (Feb. 8)-Corautus Genetics Inc. (www.corautus.com) has signed a difinitive merger agreement with VIA Pharmaceuticals, Inc. (San Francisco, CA, www.viapharmaceuticals.com). The merger will create a drug development company focused on compounds that target inflammation in the blood vessel wall as a treatment for cardiovascular disease. The transaction is expected to close in the second quarter of 2007.
Rockville, MD (Feb. 16)-The US Food and Drug Administration (FDA, www.fda.gov) reissued its warning to consumers about the dangers of buying prescription drugs online after a number of drugs ordered online were found to contain haloperidol. Several consumers sought medical treatment for difficulty breathing, muscle spasms, and muscle stiffness. Testing of drugs they had ordered online showed the presence of a powerful anti-psychotic drug used to treat schizophrenia. The origin of the tablets is unknown, but the packages were all postmarked in Greece.
Rockville, MD (Feb. 15)-The US Food and Drug Administration (FDA, www.fda.gov) issued a warning letter to Abraxis Bioscience, Inc. (www.abraxisbio.com) over deviations from current good manufacturing practice at one of their plants. Following an inspection from May 16 through June 29, 2006, FDA determined that Abraxis had failed to establish and follow procedures to prevent microbiological contamination of drug products and had not investigated or maintained a written record of the investigation of any unexplained discrepacies or batch failures. Furthermore, the company had not established an adequate air supply that had been filtered through high-efficiency particulate air filters under positive pressure, and equipment for the adequate control over microorganisms had not been provided.
Paris (Feb. 19)-The French parliament, the Assemblée Nationale (www.assemblee-nationale.fr/english/index.asp), adopted legislation preventing biosimilar medicinal products from being classed as generics. The new law indicates that the potential variability of active substances and the differences in the manufacturing process for biosimilar medicines prevent them from being strictly classified as generic products. In addition, as biosimilar medicines are not identical to biotech reference products, biosimilar medicines cannot be automatically substituted for another biological medicine without the consent of the prescribing physician.
Goettingen, Germany (Feb. 22)-Sartorius AG (www.sartorius.com) has agreed to acquire a majority stake in biopharmaceutical supplier Stedim Biosystems S.A. (Aubagne, France, www.stedim.com) for EUR 43 per share. Sartorius also will combine its biotechnology division with Stedim's business. The transaction is expected to be completed in summer 2007.
Horsholm, Denmark (Feb. 19)-Peter G. Nielsen has been appointed senior vice-president of pharmaceutical development and CMC with LifeCycle Pharma (www.lifecyclepharma.com). He will be responsible for building the CMC organization and overseeing the areas of pharmaceutical, analytical, and manufacturing development. Nielson joins LifeCycle from Novo Nordisk, where he served as vice-president for formulation and clinical supplies in CMC supply.
Branford, CT (Feb. 21)-Neurogen Corporation (www.neurogen.com) has appointed three executives vice-president. Arunee Changchit, a Neurogen employee since 1992, will serve as vice-president of drug metabolism and pharmacokinetics. Jeffrey Dill has been promoted to vice-president, general counsel and secretary, and Ricardo Ochoa will serve as vice-president of preclinical safety.
Waltham, MA (Feb. 22)-PerkinElmer, Inc. (www.perkinelmer.com) has appointed Richard F. Begley, PhD, vice-president and general manager of its analytical sciences business. In this capacity, he will lead the growth strategy for the organization's portfolio of analytical instrumentation. He previously served as president and chief executive officer of Ensemble Discovery.
Fair Lawn, NJ (Feb. 20)-Vyteris, Inc. (www.vyteris.com) promoted five members of its current executive team. Ash Sharma, PhD, has been appointed executive vice-president. Sharma has been with the company since 2000. Michael Reidy, PhD, has been promoted to vice-president of research, Cormac Lyons, PhD, has been appointed vice-president of development, and George Baskinger has been promoted to vice-president of regulatory affairs. In addition, Steven Dal Cortivo has been promoted to director of quality assurance.