News
>All
Supply Chain Technology, Real-Time Quality System Win Microsoft Awards
June 22nd 2006Microsoft Corporation (Redmond, WA) announced the winners of the Microsoft Pharmaceuticals and Life Sciences Innovation Awards 2006 at this year?s meeting of the Drug Information Association in Philadelphia, Pennsylvania. A four-person panel of industry experts selected winners for the innovative use of Microsoft products in pharmaceutical and life sciences business processes and practices.
Strategies for Optimizing the Preformulation Process Examined
June 16th 2006Preformulation represents an early-stage opportunity to facilitate the eventual movement of a drug substance into a commercial product. Strategies to optimize the preformulation process were outlined by Harry Brittain, institute director for the Center for Pharmaceutical Physics (Milford, NJ). He spoke at the PharmTech Annual Event in Somerset, New Jersey this week.
Bayer Makes Peace with Merck KGaA to Win Schering AG
June 16th 2006The ongoing battle between Bayer AG (Leverkusen, Germany) and Merck KGaA (Darmstadt, Germany) in their respective quests to acquire Schering AG (Berlin, Germany) was resolved this week, with Merck KGaA agreeing to sell its 21.8% stake in Schering to Bayer.
PharmTech Annual Event Highlights Process Optimization, Product Quality
June 16th 2006This week?s PharmTech Annual Event (www.pharmtechevent.com) in Somerset, New Jersey, targeted approaches to improving drug development and quality through optimizing processes, managing risk, and controlling variations in manufacturing operations.
Industry Examines Approaches for Characterizing APIs
June 16th 2006Accurate characterization of active pharmaceutical ingredients (APIs) is a critical part of the drug development process. The approaches used to characterize APIs with respect to structure, identification of impurities, and the solid-state were discussed by Andrew C. Kolbert, manager, molecular structure and spectroscopy, Cardinal Health (Dublin, OH).
FDA to Strengthen Fight Against Counterfeit Drug Products
June 15th 2006The US Food and Drug Administration?s Counterfeit Drug Task Force (Rockville, MD, www.fda.gov) is recommending regulatory actions and the implementation of new technologies for reducing the risk of counterfeit drugs entering the United States. The group has followed up on its original 2004 report, in which it outlined the framework for protecting the public from counterfeit medicines, and an updated 2005 report with a third document encouraging electronic pedigrees, improved traceability in the drug supply chain, and the adoption of radio-frequency identification (RFID) tools.
Cangene to Contribute Antibotulism Drug to National Stockpile
June 8th 2006The US Department of Health and Human Services (HHS, Washington, DC) awarded biotech company Cangene (Winnipeg, MB, Canada) a $362-million Project Bioshield supply contract for 200,000 doses of botulinum toxin immune globulin (heptavalent botulism antitoxin).
SR Pharma Develops One-Step Reconstitution for Lyophilized siRNA Drugs
June 8th 2006RNAi therapeutics company SR Pharma plc (London, UK) has developed a process that allows it proprietary liposomal-based siRNA formulations ?AtuRNAi? drugs to be stored at room temperature and reconstituted in one step.
WHO Urged to Release All Sequestered Sequences of H5N1
June 8th 2006Recombinomics (Pittsburgh, PA) is again urging the World Health Organization to fully release all H5N1 avian influenza sequences, claiming their release would improve the selection of vaccines by helping scientists to identify the origin of the isolates and predict sequence changes.
Solutia Europe Agrees to Sell Pharmaceutical Services Business
June 2nd 2006Solutia Inc. (St. Louis, MO) announced that its subsidiary, Solutia Europe SA/NV (SESA), had reached a definitive agreement to sell its pharmaceutical services business, which comprises CarboGen AG and AMCIS AG. Under the terms of the agreement, Dishman Pharmaceuticals and Chemicals Ltd. (Ahmedabad, India) will purchase 100 percent of CarboGen and AMCIS stock and related assets for $74.5 million, subject to a working capital adjustment.
FDA Approves Sandoz's Omnitrope as Follow-on Protein Product
June 2nd 2006Sandoz (Holzkirchen, Germany), the generics arm of Novartis (Basel, Switzerland), received approval from the US Food and Drug Administration (Rockville, MD) for "Omnitrope" (somatropin [rDNA origin]), a follow-on version of a previously approved recombinant human growth hormone (rhGH) product.
China Seeks to Strengthen Regulatory Supervision of Drug Manufacturers
June 2nd 2006China?s State Food and Drug Administration (SFDA, Beijing, China) issued a notice on May 18, 2006, requiring drug regulatory departments of provinces, autonomous regions, and municipalities to further strengthen the supervision and management of drug manufacturers.
FDA Withdraws Seven CMC and Stability Guidance Documents
June 2nd 2006The US Food and Drug Administration (Rockville, MD) is withdrawing seven guidance documents "because some of the principles in these guidances are inconsistent with the agency's initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century (CGMP Initiative) .
