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Webcast: Overcoming Formulation Challenges of Parenteral Drugs Sponsored by Croda Research Webcast: Best Practices for Achieving Product Quality in Sterile Manufacturing Sponsored by Baxter Webcast: Accelerate the Development of Challenging Drug Candidates via Crystal Engineering Sponsored by Catalent MORE WEBCASTS iPharma2013 February 11–12, 2013 Philadelphia, USA PharmaPack Europe 2013 February 13–14, 2013 Paris, France   Join our online community Advertisement: Life Sciences Guidebook: Best Practices for FDA Compliance Solutions As Life Science organizations evolve, product lifecycles are speeding up to accommodate market demand and keep up with competing products. As a result, quality benchmarks need to evolve as well. Read this guide on FDA Compliance Systems and learn how your company can save time, increase your ROI and more. Learn how to select a solution, best practices for FDA compliance and Quality solutions, and tips for implementation successRead More

January 10, 2013 PharmTech.com PRINT SUBSCRIBE DIGITAL SUBSCRIBE Abbott Spins off AbbVie as Independent BioPharm Company AbbVie, a research-focused, specialty  biopharmaceutical company recently spun off from Abbott, was  officially launched earlier this month. Eli Lilly Announces 2013 Financial Guidance Eli Lilly expects overall revenue growth in 2013 and claims that the company is on track to meet or exceed its minimum financial performance targets. Partnership Aims to Advance Malaria Vaccine R&D The PATH Malaria Vaccine Initiative and Inovio Pharmaceuticals have announced a follow-on collaboration to advance the development of malaria vaccines and new vaccine delivery technologies. Pharma Report from Brazil The health ministry of Brazil has recently signed an agreement with US-based Bristol-Myers Squibb to obtain its patented production technology in order to locally develop the antiretroviral drug atazanavir sulfate. When Will Pharmacogenomics Live Up to its Promise? Researchers have used quantitative modeling to estimate how much time and money may be required before pharmacogenomics can be expected to be used in clinical care. 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 FDA's Orphan Drug Act celebrates its 30th year in 2013. FDA lists 2012 new, revised, and withdrawn guidance documents. FDA releases Guidance for Industry and Investigators, Safety Reporting Requirements for INDs and BA/BE Studies. FDA releases Guidance for Industry, Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. Advertisement: Download the FDA Compliance Kit today and align your Quality Management System with federal regulations. The kit includes valuable resources such as an e-Book on FDA regulations, two White Papers on 21 CFR Part 11, and an Application Note on 10 need-to-know tips on how to respond effectively to Form 483s. Get the kit now... Almac and TTP Labtech have formed an alliance in the field of fluorescence lifetime technology. Coating Place has been granted the third in a series of patents for delivering extended-release drugs from ion exchange resins. CP Kelco, a producer of carboxymethyl cellulose (CMC), plans to increase capacity at its production facility in Finland. Evotec has acquired Cell Culture Service (CCS), a Germany-based company that supports the cell-culture needs of companies in the biotechnology and pharmaceutical industries.

What area of the pharmaceutical industry do you think will experience the most change in 2013? Manufacturing equipment and processes 12%   Outsourcing Services 16%       Drug delivery methods 10%       Information Technology 8%       Regulation policy and enforcement 18%       Biosimilars and generics 36% This week we would like to know... What area do you think will see increased regulatory attention and enforcement in 2013? Contact Us Click here to contact editorial. Click here to contact sales.

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