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Ash Stevens (Detroit, MI), a contract drug development and CGMP manufacturer, is planning a $6-million expansion project to upgrade its active pharmaceutical ingredient manufacturing facility in Riverview, Michigan. The plan’s initial phase includes an isolated new reactor bay, which will house two 100-gallon glass-lined reactors and a 50-gallon hydrogenation vessel. The new reactor bay will provide redundant capacity to a similarly designed existing bay that holds three 100-gallon reactors, while providing additional plant capacity and plant-scale hydrogenation capabilities. The company expects the initial phase to be operational in January 2010.
Continental Disc Corporation (Leiden, The Netherlands) will begin to support all sales, customer service, and logistics for the United Kingdom and other European countries from its facilities in Leiden, The Netherlands, beginning Jan. 2, 2010.
Evonik Industries (Essen, Germany) will acquire Eli Lilly’s (Indianapolis, IN) Tippecanoe Laboratories manufacturing facility in Lafayette, Indiana. The site, which employs about 700 people, manufactures active pharmaceutical ingredients and precursor materials for the pharmaceutical industry. The purchase price was not disclosed. The transaction is expected to close by the end of the year, pending customary regulatory approvals.
GeoVax Labs’ (Atlanta, GA) HIV/AIDS vaccine will be the first clinical candidate that is formulated and filled under Formatech’s (Andover, MA) Fillanthropy Program, according to a company press release. Formatech’s Fillanthropy Program states that the company will donate the services required to aseptically fill and finish one lot of drug product for selected therapeutic candidates that are entering human clinical trials. The production run is scheduled to be completed in January 2010.
Lonza Group (Basel) withdrew its bid to acquire all of the outstanding restricted voting shares of Patheon (Research Triangle Park, NC) at a price of $3.55 per restricted voting share. Lonza said that “a combination of factors including value considerations, the rejection of the Lonza proposal by the majority shareholder of Patheon, and the availability to Lonza of possible alternatives makes the proposed acquisition unattractive to Lonza at this time,” in a company press release.
In a separate announcement, Lonza said it completed the acquisition of the preclinical cell and molecular biology assets of Simbiosys Biowares India (Bangalore, India). Simbiosys Biowares, a subsidiary of Simbiosys Biowares (Dallas, TX), is a biology outsourcing company focused on primary cell isolation and tissue sourcing and in performing preclinical services to mid-size pharmaceutical companies.
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Pall (Port Washington, NY), a filtration, separation, and purification company, was named one of the greenest companies in America by Newsweek magazine. Pall was ranked second in the industrial goods sector and 47th among America's 500 largest companies. The publication’s first-ever list of "Green Companies" appeared in the Sept. 28, 2009 issue.
SAFC Pharma (St. Louis, MO), a member of the Sigma-Aldrich Group, announced that its Pharmorphix Solid State Research Laboratories in Cambridge, UK, installed a new single crystal X-ray diffraction system. The Oxford Diffraction SuperNova system, which can determine the crystal structures from a variety of crystal samples, is the first industrial installation of this instrumentation, according to a company press release.
SurModics (Eden Prairie, MN), a provider of drug-delivery and surface-modification technologies, signed a license and development agreement allowing Roche (Basel) and Genentech (South San Francisco, CA) to use its proprietary biodegradable microparticles drug-delivery system to develop and commercialize a sustained drug delivery formulation of Lucentis (ranibizumab injection). The agreement also provides Roche and Genentech with opportunities to develop additional compounds for the treatment of ophthalmic diseases. Under the terms of the agreement, SurModics will receive an up-front licensing fee of $3.5 million. In addition, SurModics could receive up to approximately $200 million in fees and milestone payments, as well as undisclosed royalties on product sales.
Vetter (Ravensburg, Germany), a provider of aseptically prefilled injection systems, will open Vetter Development Service (VDS), a customer service facility located in Chicago, Illinois. Vetter will be capable of aseptically filling very small quantities of products in the new facility, and sees the new facility as a major investment in Vetter Pharma International GmbH, according to a company press release. The 25,000-ft2 facility will open at the end of 2009.
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 US Food and Drug Administration and Federal Trade Commission issued a joint Warning Letter on Oct. 19, 2009, to a website offering fraudulent supplements that claim to help prevent the spread of the swine-flu virus, according to an FDA release. The website was asked to cease the fraudulent marketing and advise the agencies of its plan to discontinue fraudulent marketing within 48 hours of receiving the letter. FDA and FTC also asked consumers to be cautious of “promotions or Internet sites offering products for sale that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus.”
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Aileron Therapeutics (Cambridge, MA), a biotechnology company, appointed Steven Kafka as the company's first chief financial officer and vice-president of finance and operations. Kafka will report to CEO Joseph A. Yanchik III.
Hospira (Lake Forest, IL), a specialty pharmaceutical company, named Daphne E. Jones senior vice-president and chief information officer, effective Nov. 9, 2009. Jones will have overall responsibility for Hospira's information technology and systems, and will report directly to Chris Begley, chairman and CEO.
Specialty pharmaceutical company NovaDel Pharma (Flemington, NJ) elected Mark Baric, Thomas Bonney, Steven Ratoff, and Charles Nemeroff directors of the company at its 2009 annual meeting of stockholders. NovaDel Pharma develops oral spray formulations for a range of marketed drugs.
Peregrine Pharmaceuticals (Tustin, CA) appointed Robert Garnick head of regulatory affairs. Garnick was formerly the senior vice-president of regulatory, quality, and compliance at Genentech (South San Francisco, CA). Garnick will be responsible for overseeing Peregrine's interactions with FDA and regulatory agencies around the world.
Shrink Nanotechnologies (Carlsbad, CA), a nanotechnology company, announced that Bruce R. Conklin, a senior investigator at the Gladstone Institute and professor of medical genetics and cellular and molecular pharmacology at the University of California San Francisco, and Kara McCloskey, professor at the school of engineering, University of California, Merced, have joined its scientific advisory board. Shrink is developing biological research and development tools that employ its technology and microfabrication capabilities designed to offer new techniques for cell biology, molecular biology, immunodiagnostics, and stem-cell research.
Sundia MediTech (Shanghai, China) a pharmaceutical research and development outsourcing service company, appointed Charles D. Maher senior vice-president of sales and marketing. Maher was previously executive vice-president of global sales and marketing at Azopharma Product Development Group (Hollywood, FL). Maher will report directly to Xiaochuan Wang, chairman and CEO of Sundia.
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Special Report: The Emerging Markets of the East |
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| Angie Drakulich |
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The countries of Central and Eastern Europe and the Commonwealth of Independent States are closing in on global pharmaceutical competition.
Coming Soon: A peer-reviewed article discusses moisture-activated dry granulation in the November 2009 issue of Pharmaceutical Technology. |
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FDA's 2nd
Transparency Meeting
FDA's Transparency Task Force will hold its second public meeting on Nov 3. Is FDA's initiative to better inform the public of what it does the right step for the agency?
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