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Lilly's Zyprexa LAI Gets Non-approvable Letter

February 28, 2008
Eli Lilly and Co. received a not approvable letter from the FDA for Zyprexa long-acting injection (olanzapine LAI) for the treatment and maintenance of schizophrenia in adults. Zyprexa LAI is an investigational formulation that combines the antipsych…  Read More »
Cobra To Make SARS Protein

February 28, 2008
Cobra Biomanufacturing Plc has entered into a manufacturing development agreement with an undisclosed pharmaceutical partner to produce a protein from the SARS virus in CHO (Chinese Hamster Ovary) cells under cGMP. Simon Saxby, Cobra Biomanufactur…  Read More »
Bilcare Global Clinical Supplies

February 27, 2008
Vito Mangiardi has been appointed chief executive officer, Bilcare Global Clinical Supplies. Mohan Bhandari, chairman and managing director, Bilcare Ltd., said, "Vito is an exceptional leader and strategist. He has vast experience in global busi…  Read More »
FDA Launches Drug Safety Effort

February 27, 2008
The FDA is launching a new effort for post-approval drug safety, called "Safety First," meant to strengthen its supervision of prescription drugs after approval.     The plan, first reported by the Wall Street Journal and…  Read More »
Vetter Gets Production Approval from FDA

February 27, 2008
Vetter Pharma-Fertigung GmbH & Co. has been granted approval by the FDA for the production of a client's new drug. The company will begin filling the drug at its Ravensburg Vetter South (RVS) facility. Vetter provides contract manufacturing servi…  Read More »
Bayer Licenses Millipore Technology for Bio-Manufacturing

February 26, 2008
Bayer HealthCare AG has entered into a worldwide, non-exclusive license agreement with Millipore to use its UCOE (Ubiquitous Chromatin Opening Element) technology to manufacture its biologic drugs. The license will enable Bayer to manufacture recombi…  Read More »
Boston Scientific Corp.

February 26, 2008
Jay J. Schnitzer, M.D., Ph.D. has been named vice president and associate chief medical officer for Boston Scientific Corp.'s clinical leadership team, effective March 24.     Dr. Schnitzer will be responsible for leading the medica…  Read More »
Ambrx, Inc.

February 26, 2008
Douglas W. Axelrod, M.D., Ph.D., has been appointed senior vice president for clinical R&D, Ambrx, Inc.     Dr. Axelrod joins the company after a 20-year career at Procter & Gamble Pharmaceuticals. Most recently, he served a…  Read More »
United BioSource Expands Regulatory Affairs Group

February 25, 2008
United BioSource Corp. (UBC) has expanded its regulatory affairs group led by Mark Ammann, Pharm.D. and LaVonne Lang, Dr. PH. The group, based in Ann Arbor, MI, will provide a full range of services to pharma and biopharma clients, including creating…  Read More »
Avastin Combo Gains Accelerated Approval in Breast Cancer

February 25, 2008
Genentech received accelerated approval from the FDA for Avastin in combination with paclitaxel chemotherapy for the first-line treatment of patients with locally recurrent or metastatic breast cancer. The approval is based on Phase III study (E2100)…  Read More »
Abbott's Humira Gains JIA Approval

February 25, 2008
Abbott received FDA approval to market Humira as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients four years of age and older. The approval is based on safety and…  Read More »
Azopharma Opens South Florida Facility

February 22, 2008
Azopharma Product Development Group, Inc. has opened a new facility in South Florida. The new 22,000-sq.-ft. facility will house the company’s formulation development services, small-scale manufacturing, development services and specialized ana…  Read More »
Prasugrel Receives Priority Review

February 22, 2008
The NDA for prasugrel, a treatment for patients with acute coronary syndrome being managed with percutaneous coronary intervention (PCI), has received priority review status from the FDA. Prasugrel, submitted by Daiichi Sankyo Co. and  Eli Lilly…  Read More »
Molecular Profiles

February 22, 2008
Molecular Profiles, a contract research services provider, has named Dr. Mike Fanfarillo as operations director and Dr. Robert Sherry as associate director in pharmaceutics. "We are delighted to announce these two new appointments as an expansio…  Read More »
Cook Pharmica

February 21, 2008
Fred Larimore, Ph.D. has been named vice president of scientific affairs and chief scientific officer for Cook Pharmica, the global contract biopharmaceutical manufacturing division of Cook Medical.     Dr. Larimore has more than 25…  Read More »

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