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Also, Zentiva accepts Sanofi's increased takeover bid, Oriel Therapeutics appoints Richard Fuller CEO, more...
San Francisco, CA (Sept. 17)-Bilcare Global Clinical Supplies, a provider of clinical trial supplies and services, completed the expansion of its warehouse and distribution facility in Phoenixville, Pennslyvania. Bilcare’s facility now provides 300% more ambient storage capacity, as well as a 50% larger distribution pack-out area and a second distribution dock.
Washington, DC (Sept. 18)-Members of the Committee on Energy and Commerce announced they have expanded their inquiry into the FDA’s dealings with Ranbaxy Laboratories. The committee will now investigate the safety and effectiveness of drugs manufactured by Ranbaxy for the President’s Emergency Program for AIDS Relief (PEPFAR). According to a statement on the committee’s website, “Allegations have been raised regarding serious irregularities in the application and production process at Ranbaxy.” In July, committee members launched an inquiry into whether FDA “knowingly allowed drugs suspected of being fraudulently approved and manufactured in gross violation of Good Manufacturing Practices (GMP) to continue being sold in the United States” according to the website.
On Sept. 17, Ranbaxy announced that former New York City Mayor Rudy Giuliani and Giuliani Partners will assist the company with compliance issues related to the warning letters and import advisory issued by FDA last week.
Leiden, The Netherlands (Sept. 18)-The biopharmaceutical company Crucell signed an exclusive, commercial license agreement with Talecris Biotherapeutics (Research Triangle Park, NC) for an undisclosed and specific protein to be produced using Crucell’s “PER.C6” cell line. Crucell will receive an upfront payment of $2.5 million and will be eligible for milestone payments of approximately $30 million. Further financial details of the agreement were not disclosed.
Also, Crucell announced on Sept. 23 that it received new contracts from various organizations of $140 million for supplies of “Quinvaxem” and “Hepavax-Gene” for the period 2008–2009, bringing the total for the period 2007–2009 to $0.5 billion.
Muenster, Germany (Sept. 11)-Pharmaceutical service provider Diapharm is now offering accredited shared third-party audits for active pharmaceutical ingredients (APIs). Diapharm’s audit reports serve to prove whether the rules of good manufacturing practices (GMPs) are followed in the manufacture of ingredients. This proof of GMP compliance is mandatory for European manufacturers of medicinal products.
Heerlen, NL (Sept. 17)-DSM Biomedical and Caliber Therapeutics (Boston) signed a drug-delivery pact to develop a novel balloon catheter that can be used to treat vascular diseases. The partnership will combine proprietary technology from DSM on drug delivery with balloon and catheter technology from Caliber. In addition, DSM will grant Caliber a worldwide exclusive license for the use of DSM’s “Trancerta” drug-delivery platform for the development of this specific application.
Cambridge, MA (Sept. 22)-Genzyme marked the grand opening of its Science Center in Framingham, Massachusetts. The facility serves as a central site for early-stage research. The company announced that the Science Center received a gold certification under the US Green Building Council's “LEED” (Leadership in Energy and Environmental Design) “Green Building Rating System.” It is one of only 10 laboratories to achieve this high rating.
Princeton, NJ (Sept. 18)-Laureate Pharma, a biopharmaceutical development and protein production company, will increase its existing manufacturing capacity by adding two single-use bioreactors (SUBs), one 250 L and a 1000 L unit. The SUB is a single-use alternative to conventional stirred tank bioreactors.
Basel (Sept. 19)-Novartis announced that a new study showed that its “MF59”-adjuvanted vaccine triggered a rapid protective immune response to diverse strains of avian flu. The study showed that the investigational prepandemic vaccine “AFLUNOV” provides rapid immune response in individuals primed with MF59-adjuvanted H5 vaccine up to six years earlier. Individuals primed with the MF59 adjuvant developed immunity seven days after receiving the AFLUNOV booster. Novartis says this study supports notion of prepandemic vaccination to ensure protective antibody levels in the population, with one additional immunization in the event of a pandemic. These data were presented at the Third European Influenza Conference in Vilamoura, Portugal.
San Diego, CA (Sept. 17)-Pharmatek, a provider of chemistry development services, opened a cytotoxic facility in San Diego. The 18,000-ft2 facility includes newly constructed analytical and formulation development laboratories and CGMP manufacturing suites dedicated to the development of highly-potent and cytotoxic drug products for early phase clinical trials.
Lowell, MA (Sept. 23)-UMass Lowell opened a fully automated biomanufacturing pilot plant designed to help Massachusetts biomanufacturing companies bring new biopharmaceuticals closer to commercial production and serve UMass Lowell faculty by providing a home for biomanufacturing research. The Massachusetts BioManufacturing Center facility was made possible through equipment and services donated by Invensys Process Systems (Plano, TX), Wyeth Biotech (Madison, NJ), Dakota Systems (Dracut, MA), and Millipore (Billerica, MA). The four companies' contributions are worth $600,000, UMass Lowell officials announced.
Aliso Viejo, CA (Sept. 17)-Valeant Pharmaceuticals International signed a definitive agreement to acquire Coria Laboratories (Fort Worth, TX), a privately held specialty pharmaceutical company focused on dermatology products. Valeant will purchase all of the outstanding shares of Coria from its parent company, DFB Pharmaceuticals, and other shareholders for $95 million. The transaction is expected to close following customary regulatory approval.
Prague (Sept. 22)-Zentiva and Sanofi-Aventis (Paris, France) agreed on the unanimous recommendation by Zentiva of a cash public offer of CZK 1,150 per share ($69 per share), an estimated total of $2.6 billion, by Sanofi-Aventis’ wholly-owned subsidiary Sanofi-Aventis Europe to acquire all issued ordinary shares of Zentiva. Sanofi’s previous bid of CZK 1050 per share ($63 per share), or approximately $2.39 billion, had been rejected because Zentiva felt it undervalued the company.
Indianapolis, IN (Sept. 22)-AIT Laboratories, a contract analytical laboratory, named Ronald Shoup executive director of its Pharma Services division. Shoup is a former cofounder and chief scientific officer of Bioanalytical Systems (West Lafayette, IN).
Redwood City, CA (Sept. 23)-Codexis, a biotechnology company, appointed Lynn Marcus-Wyner vice-president of intellectual property. She will be responsible for managing the company’s intellectual property strategy and will report to Douglas Sheehy, vice-president, general counsel and secretary.
Rye, NY (Sept. 23)-Curemark, a biotechnology company, appointed Elisa J. Zinberg vice-president of operations and member of Curemark’s management team, effective immediately. Zinberg will be responsible for the day-to-day management of Curemark as well as for the implementation of Curemark’s strategic plan.
Wilmington, DE (Sept. 24)-The DuPont board of directors elected Ellen Kullman president and a director of the company effective Oct. 1, 2008 and chief executive officer (CEO) effective Jan. 1, 2009. DuPont Chairman and CEO Chad Holliday will serve as chairman of DuPont and as a member of the board until Kullman’s expected succession as chairman.
Indianapolis, IN (Sept. 18)-Eli Lilly and Company’s board of directors appointed John C. Lechleiter chairman of the board, effective January 1, 2009. Lechleiter, Lilly's president and CEO, will succeed outgoing chairman Sidney Taurel, who had previously announced his retirement from the company and the board effective December 31, 2008. Taurel will be designated chairman emeritus in recognition of his contributions to the company during his tenure as chairman and CEO.
Research Triangle Park, NC (Sept. 23)-Oriel Therapeutics, a specialty pharmaceutical company focused on respiratory care, appointed Richard Fuller CEO, effective immediately. Fuller is a former executive at GlaxoSmithKline.
Lebanon, PA (Sept. 17)-SCHOTT North America, a producer of pharmaceutical packaging components, named Renard Jackson as the company’s vice-president and general manager for its Pharmaceutical Systems business. Jackson will be based in SCHOTT’s flagship North America Pharmaceutical Systems facility in Lebanon, Pennsylvania.
Basel, Switzerland (Sept. 23)-The pharmaceutical company Vivendy Therapeutics announced that CEO Roland Toder will step down, effective September 30, 2008. Toder cited personal reasons for his decision. The board of directors nominated Gosse B. Bruinsma to the board, and Bruinsma will also assume an executive function that will encompass the activities of the CEO.