Pharmaceutical Technology ePT Weekly: Having trouble viewing this e-mail? Click here.

News Product Spotlight Industry Briefs PharmTech, the magazine

Accelerate the Development of Challenging Drug Candidates via Crystal Engineering Sponsored by Catalent (On Demand) Best Practices for Achieving Product Quality in Sterile Manufacturing Sponsored by Baxter (On Demand) Webcast: Overcoming Formulation Challenges of Parenteral Drugs Sponsored by Croda (On Demand) MORE WEBCASTS 11th Winter Conference on Medicinal & Bioorganic Chemistry January 20, 2013–January 24, 2013 Steamboat Springs, Colorado Quality by Design January 23, 2013–January 24, 2013 London, United Kingdom Social Media in the Pharmaceutical Industry January 23, 2013–January 24, 2013 London, United Kingdom Pre-Filled Syringes January 28, 2013–January 29, 2013 London, United Kingdom CBI's 4th Annual Effective Preparation for FDA Advisory Committee Meetings February 5, 2013–February 6, 2013 Washington, DC

January 3, 2013 PharmTech.com PRINT SUBSCRIBE DIGITAL SUBSCRIBE Mylan Recalls Painkiller Pills Due to Risk of Higher Dosage Mylan issued a voluntary recall of three lots of the painkiller tablets hydrocodone bitartrate and acetaminophen. GlaxoSmithline Partners with Vodafone for Vaccinations GlaxoSmithKline has formed a partnership with Vodafone to use mobile technology to help vaccinate more children against common infectious diseases in Africa. FDA Approvals of NMEs and BLAs Increased in 2012 Additional approvals in December have helped to outpace a recent high set in 2011. BASF Extends Offer Period to Acquire Pronova BioPharma BASF has extended its offer period to acquire Pronova BioPharma, a producer of omega-3 fatty acids. Advertisement: Together: It's how we work. It's how we help Pharma Succeed. Look to Agilent for real world solutions that help pharmaceutical companies discover more rapidly and more efficiently. The Agilent RapidFire High-throughput System and 6550 iFunnel Q-TOF mass spec helped one lab reduce a week of work to 4.5 hours, transforming their productivity. Discover more, and request your free ADME Solutions Guide at our new pharma web page: www.agilent.com/chem/togetherADME Pressure transmitter for efficient manufacturing processes Honeywell’s SmartLine industrial pressure transmitters are designed to enhance communication abilities, improve operational efficiency and reduce lifecycle costs for process manufacturers. The transmitters are intended to make it easier to support field devices and promote plant reliability with their efficiency-enhancing features, such as a graphic display capable of showing process data in graphical formats and communicating messages from the control room. SmartLine transmitters also feature modular components to simplify field repairs and reduce inventory required to make such repairs. Mylan Pharmaceuticals has entered into a settlement agreement with Orion that will resolve patent litigation related to 200-mg entacapone tablets. Entacapone tablets are the generic version of Orion’s Comtan, for treating patients with idiopathic Parkinson’s Disease who experience the signs and symptoms of end-of-dose “wearing-off.” Under the agreement, Mylan may launch a generic version of 200-mg Comtan on Apr. 1, 2013, at the earliest. Pursuant to the agreement, pending litigation will be dismissed. All other terms and conditions of the settlement are confidential, and the agreement itself is subject to review by the US Department of Justice and the Federal Trade Commission. Read More Sanofi has agreed to acquire the animal-health division of the India-based company Dosch Pharmaceuticals, creating a market entry for Merial (Sanofi’s animal-health division) in India’s animal-health sector. The agreement is subject to regulatory approval and is expected to finalize in the first half of 2013. Read More Takeda Pharmaceutical has established of a new organization, “Global Customer Market Business Insights Department,” with the appointments of its senior leadership, effective Jan. 1, 2013. In addition, Takeda has changed of the name of the “Metabolic Disease Drug Discovery Unit” of its Pharmaceutical Research Division to “Cardiovascular and Metabolic Drug Discovery Unit.” Read More In other news, Takeda and Amylin Pharmaceuticals have mutually terminated their worldwide agreement—originally signed in October 2009—to codevelop and commercialize compounds for treating obesity. The companies announced in August 2011 their decision to discontinue the development of pramlintide/metreleptin, an investigational combination therapy for treating obesity. That joint decision was based on a commercial reassessment of the pramlintide/metreleptin program, which had been in Phase II development as a twice-a-day injection formulation. The companies have since determined to formally terminate the partnership. Read More A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More Development and Commercialization of a Novel Modified Release Tablet Technology by: Kevin D. Altria and James Taylor GlaxoSmithKline recently developed a novel technology for the formulation of modified-release tablets. The authors describe the route from development to commercialization. Coming soon: Pharm Tech’s January issue examines API synthesis and manufacturing strategies in API scale-up.

Regulatory Enforcement What area do you think will see increased regulatory attention and enforcement in 2013? View the poll archive.   >>Recent Posts Industry Conferences, Manufacturing, Trends Roche on Continuous Manufacturing at PDA/EMA Joint Conference North America News Purchaser of Unapproved Drugs Pleads Guilty Industry Conferences, Manufacturing, Regulation PDA-EMA Joint Conference on Process & Validation >>Go to the Blog Homepage

| Subscribe | Send Feedback | Advertise With Us | Visit PharmTech.com |