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Biostatistics for Non-Statisticians
July 11–July 13, 2011
Los Angeles, CA
CPhI Japan
July 13–July 15, 2011
Osaka, Japan
3rd Annual Effective Business Development Outsourcing Relationships Conference
July 19–July 21, 2011
Philadelphia, PA
Pre-Filled Syringes Asia Pacific
July 20–July 21, 2011
Singapore
BioProcessing, Biologics & Biotherapeutics
July 20–July 21, 2011
Edinburgh, Scotland
World Cell Line Development & Scale Up Summit
July 26–July 28, 2011
London, United Kingdom 
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FDA Withdraws Approval for Roche's Avastin
An FDA panel has voted unanimously to withdraw approval for Roche's Avastin for use in the treatment of metastatic breast cancer because there is not enough data to support that the benefits outweigh the risks.  FDA Q11 Draft Guidance Available for Comment
FDA issued a draft guidance, entitled “Q11 Development and Manufacture of Drug Substances," which is now available for comment according to a notice published on June 29, 2011, in the Federal Register. 
House Committee Expands Investigation into Tainted Heparin
Members of the House Energy and Commerce Committee are expanding their investigation into the 2008 entry of contaminated heparin from China into the United States market. 
EMA Welcomes New Directive on Falsified Medicines
The European Medicines Agency has responded positively to a new directive published in the Official Journal of the European Union addressing concerns over increases in falsified medicines in the supply chain. 
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Bioreactor controls growth variables
Cole-Parmer's IKA BR 10 bioreactor is designed to ensure the optimal cell growth of phototrophic organisms, including algae and many species of bacteria. Through a human–machine interface, operators can set timers to control the lighting, motion, pH, and temperature within the bioreactor. An in-line DC motor connected to a PTFE stirrer controls the motion within the unit. The motor can operate at low speeds for gentle agitation that provides good oxygen transfer without damaging fragile cells. Users can easily remove the motor by adjusting one thumbscrew.
The system monitors and controls pH through an automatic carbon-dioxide valve. A separate probe monitors the temperature of the vessel. Users can connect the outer jacket to a recirculation bath for optimal temperature control. A glass sparger tube provides constant oxygen transfer and mixes carbon dioxide. The 10-L bioreactor can be used as a modeling tool for scale-up applications and can be customized for specific applications.
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Bristol-Myers Squibb and Matrix Laboratories Limited, a Mylan subsidiary, have agreed to expand access to Reyataz (atazanavir sulfate) for the treatment of HIV. This immunity-from-suit agreement enables Matrix to manufacture and sell atazanavir, stavudine, and didanosine, in sub-Saharan Africa and India.
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Gilead Sciences and the specialty pharmaceutical company Tibotec Pharmaceuticals have agreed to develop and commercialize a new fixed-dose antiretroviral combination product containing Gilead's cobicistat and Tibotec's protease inhibitor Prezista (darunavir). Cobicistat is an investigational pharmacoenhancing agent that increases blood levels of certain HIV medicines to enable once-daily dosing. Prezista is indicated in the United States for the treatment of HIV-infected individuals and is coadministered with ritonavir in combination with other antiretroviral agents. Under the terms of the agreement, Tibotec will be responsible for the formulation, manufacturing, registration, distribution, and commercialization of the cobicistat and Prezista fixed-dose combination worldwide. Gilead retains sole rights for the manufacture, development, and commercialization of cobicistat as a stand-alone product and for use in combination with other agents. The deal is subject to customary closing conditions and regulatory approval.
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Merck KGaA has announced that the European Commission has granted an approval for three prefilled, ready-to-use pen injectors for fertility treatment. This group of pens is designed for self-administration of the liquid formulations of its three recombinant gonadotropins used in fertility treatments: Gonal-f (follitropin alfa) 300 IU, 450 IU, and 900 IU, Luveris (lutropin alfa) 450 IU, and Ovidrel/Ovitrelle 250 micrograms (choriogonadotropin alfa).
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Pfizer and the Russian pharmaceutical investment and research and development (R&D) group ChemRar High Tech Center have signed a Memorandum of Understanding (MoU) to explore a collaboration focused on the research, development, and commercialization of drugs in Russia and other countries. Under the terms of the MoU, the companies can further collaborate with other potential partners, including the Moscow Institute of Physics and Technology, the Skolkovo Foundation and other members of the Russian Biopharmaceutical Cluster "Northern," created under the Federal Target Program of the Ministry of Industry and Trade of the Russian Federation. In addition, the companies can establish a shared-risk platform for several Pfizer R&D programs designed to achieve clinical candidates and proof of concept in the clinic.
Sanofi has entered into a research collaboration with Weill Cornell Medical College to identify new anti-infectives for the treatment of tuberculosis. Under the terms of the collaboration, Sanofi will provide 80,000 chemical compounds to Dr. Carl Nathan's laboratory at Weill Cornell, where the compounds will be screened to assess their ability to inhibit growth of Mycobacterium tuberculosis. Weill Cornell has secured funding for the screening activities conducted by Nathan's team from the Bill & Melinda Gates Foundation. Sanofi and Weill Cornell will jointly determine if any compounds screened through the collaboration should be brought forward for optimization and potential development.
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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Michael A. Schulz was appointed as a member of the board of management of Bayer CropScience effective June 1, 2011, and as the company's head of business planning and administration effective July 1, 2011. He succeeds Dirk Suwelack, who will retire at the end of 2011.
The contract reseach organization INC Research has appointed Chris Smyth to its oncology leadership team as senior vice-president of clinical development. Smith has more than 20 years of R&D experience in the pharmaceutical industry. Prior to joining INC Research, he spent eight years at a biopharmaceutical company specializing in the development of small molecules, biologicals, and DNA aptamers for the treatment of cancer.
Tengion, a clinical-stage biotechnology company, has announced the resignation of Steven A. Nichtberger from his role as president, CEO, and member of the company's board of directors. David I. Scheer, Tengion's current chairman of the board, will assume an interim leadership role while an external search is conducted for a new CEO.
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The Challenges of Research & Development
Should pharma search for external drug candidates to refill the pipeline or develop internal R&D capabilities? Renee Cohen (vice-president of corporate strategy at Shire) and Ray Jupp (vice-president of the fibrosis and wound repair therapeutic strategy unit at Sanofi) join Barbara Ryan, Ken Kaitin, and Charlotte Sibley to debate how pharma can replenish its drug development pipeline in this Pharma Faceoff episode.

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Biosimilars
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