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Management of Water/Cleaning Validation
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| Abbott (Abbott Park, IL) signed a licensing and supply agreement with the pharmaceutical company Zydus Cadila (Ahmedabad, Gujarat, India) for a portfolio of pharmaceutical products that Abbott will commercialize in 15 emerging markets. Under the agreement, Abbott gains the rights to at least 24 Zydus products and will have an option for an additional 40 products. Abbott also announced the formation of a stand-alone established products division that will concentrate on expanding Abbott’s sales outside the United States.
The pharmaceutical company Ariad Pharmaceuticals (Cambridge, MA) restructured its collaboration with Merck, Sharpe & Dohme, part of Merck & Co. (Whitehouse Station, NJ) for the development, manufacture, and commercialization of ridaforolimus, an investigational mTOR inhibitor to treat select cancers. Under the amended agreement, Ariad granted Merck an exclusive license to develop, manufacture, and commercialize ridaforolimus in oncology. Merck will make an upfront payment of $50 million, and Ariad will be eligible to receive as much as $514 million in regulatory and sales milestone payments.
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Bristol-Myers Squibb (BMS, New York) formed a multiyear target-validation agreement with the biopharmaceutical company Tekmira Pharmaceuticals (Vancouver) for small interfering RNA (siRNA) molecules. Under the agreement, BMS will use the siRNA molecules formulated by Terkmira to silence target genes of interest.
Boehringer Ingelheim (BI, Ingelheim, Germany) and the biopharmaceutical company Micromet (Bethesda, MD) have formed a collaboration for the research, development, and commercialization of a proprietary BiTE antibody for treating multiple myeloma. Micromet is responsible for the discovery of the BiTE antibody and will jointly conduct preclinical studies with BI. BI is responsible for all manufacturing, clinical development, and worldwide commercialization. BI will pay Micromet an upfront payment of EUR 5 million ($6.6 million), and Micromet is eligible to receive up to EUR 50 million ($66 million) in development and regulatory milestone payments as well as additional royalty payments.
DSM Biologics, a business unit of DSM Pharmaceutical Products (Parsippany, NJ), reported on a successful scale-up of its proprietary XD technology from 2 L to 50 L using a Chinese hamster ovary cell line with densities of 170 million cells/mL and titres that are 5- to 10-fold higher than standard fed-batch and perfusion processes, according to the company. The XD technology, standing for extreme density, increases cell density in bioreactors using mammalian cell-culture systems and is designed to increase yield in biomanufacturing. The improvement was achieved using off-the-shelf chemically defined media within a two-week culture. The company is working on further scale-up improvements with results anticipated later in 2010.
Genentech (South San Francisco, CA), part of Roche (Basel), signed a multiyear drug-discovery alliance with Evotec (Hamburg, Germany), a drug-discovery and development firm, to discover small-molecule therapeutics.
Genzyme (Cambridge, MA) plans to pursue strategic alternatives for its genetic testing, diagnostic products, and pharmaceutical intermediates businesses. The pharmaceutical intermediates business, which develops and manufactures lipids, peptides, carbohydrates, oligonucleotides, small-molecules, and drug-delivery technologies, has a good manufacturing practice (GMP) facility in Liestal, Switzerland.
GlaxoSmithKline (GSK, London) participated in an FDA advisory committee meeting to discuss recent findings of porcine circovirus (PCV), a common virus found in pork products, in rotavirus vaccines. GSK had previously informed regulatory authorities of finding PCV-1 in its rotavirus vaccine, Rotarix. In March 2010, FDA recommended that US healthcare practitioners temporarily suspend the use of Rotarix. According to a GSK press release, the advisory committee discussed current and emerging techniques to detect viruses and the implications of using such techniques to test vaccines currently licensed or in development. FDA will make further recommendations on the use of licensed rotavirus vaccines in the US following a review of the input of the committee’s experts and available scientific information, according to the GSK release.
HCL Technologies (Noida, Uttar Pradesh, India), an information-technology (IT) services provider, signed a five-year, $500-million strategic engagement with Merck & Co. (Whitehouse Station, NJ) that extends the companies’ business- and technology-services pact. Under the agreement, HCL will provide software-led IT solutions and remote infrastructure management, as well as engineering, business, and knowledge process services.
Johnson Controls (Milwaukee, WI), an industrial services provider, won a global contract to provide workplace services to GSK. The pact will initially cover GSK sites in North America, South America, Europe, and China. Other sites will be brought on in a managed process as they are ready. Johnson Controls will provide technical and engineering services, energy management, project management, and pharmaceutical services, for GSK’s research and development, manufacturing, and corporate offices.
Jungbunzlauer (Basel, Switzerland), a manufacturer of ingredients, including pharmaceutical excipients, successfully completed an FDA GMP inspection of its manufacturing facility in Ladenburg, Germany.
Merck & Co. reached an agreement with generic-drug manufacturer Glenmark Pharmaceuticals (Mumbai) to settle the companies’ patent litigation involving Glenmark’s challenge to Merck’s patent for the anticholesterol drug Zetia (ezetimibe). Under the agreement, Glenmark will be able to launch its product on Dec. 12, 2016, or earlier, under certain circumstances, ahead of the Apr. 25, 2017 expiration date of Merck’s patent exclusivity for Zetia. Zetia had 2009 sales of $403 million.
Microtest Laboratories (Agawam, MA), a contract provider of testing and manufacturing services, has expanded fill–and finish manufacturing service for all phases of clinical trials.
The contract research organization PPD (Wilmington, NC) opened a pharmacovigilance and medical communications center in Sofia, Bulgaria.
sanofi-aventis (Paris) and Glenmark Pharmaceuticals signed a license agreement for the development and commercialization of vanilloid receptors antagonist molecules for treating chronic pain. Under the agreement, sanofi-aventis will make an upfront payment of $20 million to Glenmark and will make payments up to $325 million dependent on the products reaching development, regulatory, and commercial milestones.
SHL (Florham Park, NJ), a manufacturer of auto injectors, pen injectors, and inhaler systems, is expanding its US operations with the establishment of SHL Pharma Systems, a final assembly, labeling, and packaging operation in South Florida. The new facility is expected to be operational in the first quarter of 2011.
Waters (Milford, MA), an analytical instrumentation company, is creating a database for glycan analysis by ultra-performance liquid chromatography with Ireland’s National Institute for Bioprocessing Research and Training (NIBRT). The database is expected to be available in 2011. NIBRT will develop, maintain, and license the database, and Waters and NIBRT will comarket it.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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| Stephen F. Sundlof stepped down last week from his position as head of food safety at the US Food and Drug Administration. According to a letter posted on the FDA website from FDA Commissioner Margaret Hamburg and Deputy Commissioner for Foods Michael R. Taylor, Sundlof has accepted a two-year assignment with the Virginia–Maryland Regional College of Veterinary Medicine. Michael Landa, the current Deputy Director for Regulatory Affairs at the Center of Food Safety and Applied Nutrition, will serve as Acting Director. Roberta Wagner and Donald Kraemer, who have extensive experience at FDA, will serve as Acting Deputy Directors.
FDA is conducting a safety review of commonly used prostate cancer drugs, according to a May 3 agency press release. Specifically, gonadotropin-releasing hormone (GnRH) agonists have been associated with a small increased risk for diabetes, heart attack, stroke, and sudden death in men, says the release. Drugs in this class are marketed under the brand names Eligard (sanofi-aventis, Bridgewater, NJ), Lupron (Abbott Laboratories, Abbott Park, IL), Synarel (Pfizer, New York), Trelstar (Watson Pharmaceuticals, Corona, CA), Vantas (Endo Pharmaceuticals, Ford, PA), Viadur (Bayer Pharmaceuticals, Wayne, NJ), and Zoladex (AstraZeneca, Wilmington, DE). Several generic products in this class are also available.
Earlier this week, a US Pharmacopeia advisory panel issued a set of recommendations to bring consistency to prescription labeling and, ultimately, to help avoid patient confusion. The panel’s recommendations included organizing the label in a patient-centered manner, simplifying language, using explicit text to describe dosage and interval instructions, including purpose for use, improving readability, providing labeling in the patient’s preferred language, including supplemental information, and standardizing direction to patients. Full details on these recommendations are on the USP website. USP will consider the recommendations as it develops a new general chapter on prescription container labeling, which is expected in a few months. |
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| Genzyme (Cambridge, MA) made several leadership changes. Geoff McDonough, formerly with the company’s personalized genetic health business, has been appointed to the newly created role of regional president of the company’s organization in Europe. John Butler, formerly with the company’s renal, endocrinology, and cardiovascular businesses, will become president of the personalized genetic health business. Rogerio Vivaldi, formerly with the company’s Latin American operations, will become president of the renal and endocrinology businesses. Alison Lawson, formerly with the company’s global regulatory organization, will become general manager of the biosurgey business. |
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Novel Excipients
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Filtration system improves yields and concentrations
