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Risk Mitigation for Alcohol-Dose Dumping in Controlled Release Forms (On Demand) Sponsored by FMC Minimizing Out-of-Specification (OOS) Errors Using a Risk-based Gravimetric Approach (On Demand) Sponsored by Mettler Toledo More Webcasts BIT's 4th Annual Global Congress of Catalysis - 2013 June 29-July 1, 2013 China Pharma Trials World Korea 2013 July 8-11, 2013 South Korea Advertisement: Pharmaceutical Technology Drug Delivery Guides A 3-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects.  Important topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery. Click here

June 20, 2013 PharmTech.com PRINT SUBSCRIBE DIGITAL SUBSCRIBE The EU Changes Guidelines for Good Distribution Practices An expert discusses the European Commission's (EC) guidelines on Good Distribution Practice of Medicinal Products for Human Use. Model-Predictive Design, Control, and Optimization Applying model-predictive methods and a continuous process-control framework to a continuous tablet-manufacturing process. Methods for Identifying Out-of-Trend Results in Ongoing Stability Data The authors discuss three methods for identification of out-of-trend (OOT) results and further compare the z-score method and the tolerance interval in OOT analysis for stability studies. (Peer-reviewed article). Patent Settlements Become More Risky Pharmaceutical companies can anticipate more costly, drawn-out patent litigation in the wake of the June 17 US Supreme Court decision, which creates great uncertainty about the grounds for negotiating settlements in patent cases. Pfizer Wins Multibillion-Dollar Settlement from Teva and Sun for Infringement of Protonix Patent The settlement comes after a nearly 10-year legal battle in which Pfizer and Nycomed sought to enforce the patent for blockbuster acid reflux medicine. GSK Receives Offer for Its Thrombosis Brands and Manufacturing Site A proposed deal with Aspen includes the GSK’s site in Notre-Dame-de-Bondeville, France. Elan Initiates Formal Sale Process of Company The move follows rejection of Elan shareholders of certain key deals and withdrawal of Royalty Pharma bid. AstraZeneca Selects Cambridge, UK for New Global R&D Center and Corporate HQ The multimillion investment in a facility in Cambridge is part of the company’s move to create strategic global R&D centers in the UK, US, and Sweden. Advertisement: Pharmas and consumer healthcare organizations can benefit from the increased product safety, compliance, cost-savings and marketability offered by stick-pack packaging of Rx and supplements. Read "Stick-pack Benefits for Pharmaceuticals and Nutraceuticals," a whitepaper by Ropack's Paul Dupont. Visit www.ropack.com to learn more about Ropack's $9M, 15,000-sq-ft facility dedicated to stick-pack packaging of temperature- and humidity-sensitive products. (513) 846-0921. paul.dupont@ropack.com. J&J to Acquire Aragon Pharmaceuticals The billion-dollar deal provides strengthens J&J’s oncology portfolio. Advertisement: Support and Solutions from Agilent for Impurity Profiling: New Genotoxic Impurities Primer Agilent partners with Pharma for great results.  Download or request a hard copy of our new guide, Genotoxic Impurities in Pharmaceutical Products:  Regulations and Analysis, authored by Ludwig Huber.  The guide provides specific guidelines for genotoxic impurities and recommendations for implementation according to EMA and FDA guidelines. Get your Genotoxic Primer now US Supreme Court: Human Genes Are Not Patentable The US Supreme Court ruled that naturally occurring isolated biological material is not patentable, but a synthetic version of gene material may be patented. Advertisement: Overcoming Challenges in Development of Oral Enteric and Controlled-Release Dosage Forms Live Webcast: Thursday, July 18, 2013 at 11:00 am EDT Register Free at www.pharmtech.com/overcoming Lilly Terminates Phase II Study of Alzheimer’s Drug Eli Lilly has discontinued its Phase II study, which investigated the company’s beta secretase inhibitor, LY2886721, as a treatment for Alzheimer’s disease due to abnormal liver biochemical tests identified during routine monitoring. Advertisement: Risk-Mitigation Strategies for API Manufacturing in Emerging Markets Live Webcast: Wednesday, June 19, 2013 at 11:00 am–12:00 pm EDT Register Free at www.pharmtech.com/emerging Almac Expands UK Facility Almac has announced expansion of its UK facility and a new non-GMP drug development facility at the Craigavon site, representing an investment of $21.5 million. PSL Develops Microsphere Refiner for Formulation of Microspheres PSL has developed a microsphere refiner for microsphere formulation, from small scale processes to commercial production. Catalent Expands Controlled-Release Manufacturing Facility Catalent is investing nearly $35 million in a major expansion of its controlled-release drug manufacturing facility in Winchester, Ky.

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