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

News Regulatory Roundup Industry Briefs Webcasts Events About Us

Webcast: Improving Cell Culture Productivity: Best Practices for Automation and Control Sponsored by Parker Hannifan (On Demand) Webcast: Overcoming Formulation Challenges of Parenteral Drugs Sponsored by Croda (On Demand) Webcast: Accelerate the Development of Challenging Drug Candidates via Crystal Engineering Sponsored by Catalent (On Demand) MORE WEBCASTS Informex February 19–22, 2013 California, USA PHARM Connect Congress 2013 February 27–28, 2013 Budapest, Hungary Advertisement: Accelerate Sterile and Non-Sterile Clinical Trial Manufacturing with Single-Use Technologies Live Webcast: Wednesday, March 6, 2013 at 11:00 AM ET Register Free at http://www.pharmtech.com/ accelerate

February 7, 2013 PharmTech.com PRINT SUBSCRIBE DIGITAL SUBSCRIBE FDA Lists Guidance Documents Planned for 2013 FDA has released a list of more than 50 guidance documents planned for 2013. European Commission Investigates J&J and Novartis The European Commission claims that Johnson & Johnson and Novartis may have breached European antitrust rules. US Pharmacopeial Convention Announces Revised Official Dates for Elemental Impurities Chapters The United States Pharmacopeial Convention has re-established the official publication date of General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Methods in USP 35-NF 30, Second Supplement following an appeal. Shire to Resolve Federal Investigation and Pay $57.5 Million Shire has reached an agreement with the US government to resolve a previously disclosed civil investigation into sales and marketing practices in the US relating to the company’s attention deficit hyperactivity disorder (ADHD) drugs, Adderall XR and Vyvanse, as well as the ADHD  patch Daytrana. Pfizer Reports Fourth-Quarter and Full-Year 2012 Financial Results Pfizer has reported financial results for fourth-quarter and full-year 2012; fourth-quarter 2012 revenues were $15.1 billion, a decrease of 7% compared with the fourth quarter of 2011. GSK Increases Stake in Indian Subsidiary GlaxoSmithKline has increased its stake in its Indian subsidiary, GlaxoSmithKline Consumer Healthcare Ltd, from 43.2% to 72.5%. Future Hub of Biotech: Boston or San Francisco? San Francisco and Boston sit on opposite coasts, but they share some similarities: both cities are centers of top biotechnology hubs in the US. Pharma’s Most Productive Innovators Consultancy firm IDEA Pharma has released what it calls a ‘Productive Innovation Index’, which ranks pharmaceutical companies based on their ability to successfully commercialize new innovations. 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 has released Guidance on Photosafety Evaluation of Pharmaceuticals S10, Step 2 Version (Nov. 13, 2012). The European Medicines Agency and the Japanese Ministry of Health, Labour and Welfare (MHLW) have launched a public consultation on a joint reflection paper on the development of block-copolymer-micelle medicinal products. In the effort to resolve the shortage of the cancer drug Doxil, FDA has approved the generic version of doxorubicin hydrochloride liposome injection, made by Sun Pharma Global FZE (Sun). The United States Pharmacopeia has announced the formation of three new Expert Committees for its Medicines Compendium (MC) and an expanded and enhanced website for the online-only compendium. The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a public health campaign in partnership with pharmacy organizations to promote the need for the public reporting of suspected side effects from drugs through MHRA’s Yellow Card Scheme. Read More Advertisement: Download the Quality Toolkit with 5 popular tools for Quality and Calibration professionals, including. The Vaisala Calibration Handbook (PDF e-Book) 3 versions of Vaisala’s Humidity Calculator (HTML, iPhone App, or Executable .msi) A peer-reviewed paper on efficient validation Application Note: 8 Steps to Validation/Mapping Get the kit now… Bend Research has received certification of compliance with European Union GMP regulations. Cytovance Biologics, a contract manufacturer of mammalian and microbial biologics, plans to expand its current mammalian production capabilities. Dalton Pharma Services, a provider of drug discovery, development, and manufacturing services to pharmaceutical and biotechnology companies, has begun the first stage of its aseptic-filling expansion plan. Patheon has announced plans for additional investment in its Milton Park facility located in Oxfordshire, United Kingdom. Teva Pharmaceutical Industries has terminated its collaboration with CureTech, effective Jan. 31, 2013. Read More Industry Briefs

Which of the following has had the most significant advances in PAT over the last 5 years? Measurements devices placed at-, in- or on-line 28%   Statistical and information technology tools 24%       Scientific-systems approach for data analysis to control processes 48%       This week we would like to know... What do you think is the main challenge facing manufacturers seeking to launch a new biosimilar? Contact Us Click here to contact editorial. Click here to contact sales.

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