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Althea Technologies partners with GeoVax Labs, Nabi Biopharmaceuticals restructures, more
San Diego, CA (June 20)-Althea Technologies, Inc. was selected by GeoVax Labs, Inc. (Atlanta, GA) to manufacture its HIV-1 DNA vaccine. The vaccine is designed to prevent the development of AIDS by protecting people against HIV-1. Althea will manufacture vaccines to be used in Phase II trials that are scheduled to begin in early 2008.
Greenwich, CT (June 18)-Aptuit, Inc. and Laurus Labs Limited (Hyderabad, India) are forming a new contract drug development company to be called Aptuit Laurus. The new company, which will be based in Hyderabad, will provide integrated services, technologies, and manufacturing capabilities for the entire drug-development process. Aptuit Laurus will comprise a 160,000-ft2 research and development facility in Hyderabad, a large-scale manufacturing plant that is currently under construction in Vishakhapatnam, and Aptuit's existing Informatics Development and Support group in Bangalore. Aptuit will invest approximately $100 million during the next four years to build on Aptuit Laurus's development, manufacturing, and informatics capabilities.
Branford, CT (June 19)-CuraGen Corp. is closing its pilot manufacturing plant and reducing its workforce by approximately 40 employees. The closure was partially attributed to the company's decreased emphasis on internal manufacturing capabilities. The facility was used for pilot-scale production of proteins and antibodies.
Heerlen, Netherlands (June 15)-DSM is restructuring its anti-infectives business in an effort to make it more profitable. DSM plans to make the DSM Anti-Infectives business group a separate entity. In addition, DSM is partnering with North China Pharmaceutical Corporation Ltd. (Hebei Province, China) to create a joint venture for the production and marketing of anti-infectives in China. The restructuring is expected to result in the loss of around 100 jobs in 2007 and 2008.
London (June 13)-GlaxoSmithKline (GSK) pledged 50 million doses of H5N1 adjuvanted prepandemic influenza vaccine to the World Health Organization (WHO). The donation is part of WHO's stockpile initiative, which aims to create a stockpile of prepandemic vaccines that can be distributed to the world's poorest countries at short notice. GSK will deliver the vaccines over a three-year period.
Washington, DC (June 19)-The House Subcommittee on Health voted to forward the amendments to the Prescription Drug User Fee Act to the House Committee on Energy and Commerce. The bill was altered slightly in committee. Langauge that would have eliminated the US Food and Drug Administration's preemption authority over state laws was removed, as was a provision limiting exclusivity to six months for all drugmakers.
West Palm Beach, FL (June 19)-The US District Court for the Southern District of Florida awarded $5.5 million to the family of a man who died after using "Duragesic," a transdermal patch that contains fentanyl. The patch is manufactured and distributed by Janssen Pharmaceutica Products, LP, (Titusville, NJ) and ALZA Corp. (Mountain View, CA). Both companies are subsidiaries of Johnson & Johnson (New Brunswick, NJ). The death was attributed to a manufacturing fault that resulted in patches that leaked fentanyl.
St. Louis, MO (June 14)-KV Pharmaceutical Company acquired all the technologies, assets, and related intellectual property of Particle and Coating Technologies Inc. (PCT, St. Louis). KV hopes the acquisition will augment the development of its advanced drug-delivery product pipeline. PCT uses proprietary processes to develop products for the pharmaceutical industry that include novel particle coatings, controlled release, inhalable particle delivery, and fast-dissolving tablets.
Newton, MA (June 21)-Microfluidics unveiled its new Microfluidics Technology Center, which is located at the company's headquarters. The center houses state-of-the-art technology to help customers prepare physical samples, documentation, microscopic digital images, and particle-size analysis of improved processes. In addition, customers can receive assistance in reformulating existing products using Microfluidics's proprietary high-shear "Microfluidizer" materials processors.
Agawam, MA (June 19)-Microtest Laboratories and Texcel Medical (East Longmeadow, MA) formed a strategic alliance to help pharmaceutical manufacturers and biotechnology companies bring combination products to market. The alliance brings together Microtest's testing facilities and regulatory experience and Texcel's manufacturing infrastructure and engineering expertise.
Skokie, IL (June 20)-Midwest BioResearch, LLC (MBR) is moving to a new facility. The move is necessitated by company growth in response to increased demand for its drug-disposition and toxicology services. The new 16,000-ft2 facility is located at the Illinois Science and Technology Park in Skokie and allows MBR to select and progress proteins and small-molecule therapeutics through discovery and development faster and more efficiently.
Boca Raton, FL (June 18)-Nabi Biopharmaceuticals plans to eliminate 32 jobs, approximately 5% of its workforce, as it forms Nabi Biologics and Corporate Shared Services groups. In addition, the company is engaging in discussions for the sale of all or a significant part of the company.
Kalamazoo, MI and Vienna, Austria (June 14)-ProNAi Therapeutics, Inc. contracted Polymun Scientific GmbH to manufacture ProNAi's PNT2258 DNAi-based cancer therapy. Polymun will use its propretary cross-flow injector technology to manufacture the therapy, for which ProNAi hopes to prepare an Investigational New Drug submission later this year.
Sudbury, MA (June 11)-Proveris Scientific Corporation triumphed in a patent infringement lawsuit against InnovaSystems, Inc. (Moorestown, NJ). The suit claimed that Innova's "Optical Spray Analyzer" product infringed on Proveris's patent for spray-pattern and plume-geometry technology. The US District Court for the District of Massachusetts ordered InnovaSystems to cease manufacturing, marketing, and selling its spray analyzer and enjoined the company from servicing the infringing products that it has already sold.
Saugus, MA (June 19)-Senopsys LLC signed a collaboration agreement with Patheon Inc. (Mississauga, ON, Canada) to develop palatable drug products. The collaboration will give Senopsys's clients access to protptype drug formulations manufactured by Patheon, and Patheon will be able to give its clients taste assessment and optimization services.
Brussels, Belgium (June 13)-Solvay is expanding production capacity for ultrapure soda ash at its site in Dombasle, France. The plant's capacity will be expanded to 5 kt a year in the third quarter of 2007 to meet growing worldwide pharmaceutical demand. Soda ash is used as an excipient to make such medicines as effervescent tablets.
Orlando, FL (June 15)-Researchers at the University of Central Florida created a nanoparticle that could be an effective drug-delivery device for treating glaucoma. The nanoparticle has shown high penetration rates with little patient discomfort. It is much smaller and less abrasive than the complex polymers that are currently used in eye drops. The team created a specialized cerium oxide nanoparticle bound with a compound that blocks the activty of an enzyme believed to play a central role in causing glaucoma.
Ames, IA (June 15)-BioForce Nanosciences Holdings, Inc. named Kerry Frey president and Gregory Brown executive vice-president. Both will continue to hold their former positions of chief operating officer and chief financial officer, respectively.
London (June 19)-The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) elected Eric Abadie chair and Tomas Salmonson vice-chair. Both will serve three-year terms. Abadie and Salmonson have been members of CHMP since its formation in 2004, and they also were members of CHMP's predecessor, the Committee for Proprietary Medicinal Products.
Bloomington, IN (June 18)-Cook Pharmica promoted two employees to vice-president. Connie Degan was appointed vice-president of operations and Tedd Green was named vice-president of business operations and chief financial officer. Degan has held numerous quality and manufacturing positions. She most recently worked as quality director for Baxter Pharmacetuical Solutions. She joined Cook as director of quality in 2004 and assumed responsibility for the manufacturing group as director of operations. Green joined Cook in 2005 after serving as a senior business analyst for Eli Lilly & Company.
Cincinnati, OH (June 15)-Kendle appointed Paul Roney, PhD, and Lisa Jenkins, PhD, senior regulatory consultants. Before joining Kendle, Roney was a toxicology reviewer in the Division of Neurology Products at the US Food and Drug Administration. Jenkins joins the company after serving as senior manager of worldwide regulatory affairs at Wyeth Pharmaceuticals, Inc.
East Windsor, NJ (June 20)-NexMed, Inc. promoted Vivian Liu to chief executive officer. Liu succeeds Richard J. Berman, who served as CEO since January 2006. Liu joined the company in 1994 and was appointed executive vice-president and chief operating officer in June 2006.
Petaluma, CA (June 18)-Oculus Innovative Sciences, Inc. named Dana Redhair vice-president of regulatory affairs and quality. Redhair joins the company after serving in a similar capacity at SGX Pharmaceuticals. He has held regulatory affairs roles at Elan Pharmaceuticals, Chiron Corporation, Berlex Labs, Genentech, and UCSF Cancer Research Institute.
Berkeley, CA (June 20)-Gary C. Visor, PhD, was named vice-president of pharmaceutics with Plexxikon Inc. In this capacity, he will be responsible for managing pharmaceutical drug substance scale-up, manufacturing, and dosage design and development. He previously held positions with OSI Pharmaceuticals, Cardinal Helath, InterMune, Roche Bioscience, and Gilead Sciences.
South San Francisco, CA (June 18)-Synosia Therapeutics appointed Michael S. Eison, PhD, vice-president of regulatory affairs. Eison most recently served as vice-president of research and development for the Palo Alto site of Stiefel Laboratories. He also held regulatory positions with InterMune and Connetics.
Mississauga, ON, Canada (June 20)-Chris Waddick was promoted to president and chief executive officer of Vasogen Inc. Waddick joined the company in 1995 and most recently served as chief operating officer and chief financial officer.