ePT--the Electronic Newsletter of Pharmaceutical Technology, Feb 7, 2013 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Feb 7, 2013
News
FDA Lists Guidance Documents Planned for 2013
By Amy Ritter
FDA has released a list of more than 50 guidance documents planned for 2013.
European Commission Investigates J&J and Novartis
By Stephanie Sutton
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
By Jennifer Markarian
Two general chapters on elemental impurities? limits and procedures are to become official Feb. 1, 2013, with implementation proposed for May 1, 2014.
Shire to Resolve Federal Investigation and Pay $57.5 Million
By Adeline Siew, PhD
Shire announced that it has reached an agreement in principle with the US government to resolve the previously disclosed civil investigation into its 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
By Christopher Allen
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 $16.1 billion in the year-ago quarter, which reflects an operational decline of $802 million, or 5%, and the unfavorable impact of foreign exchange of $271 million, or 2%.
GSK Increases Stake in Indian Subsidiary
By Stephanie Sutton
GlaxoSmithKline has increased its stake in its Indian subsidiary, GlaxoSmithKline Consumer Healthcare Ltd, from 43.2% to 72.5%.
Industry Briefs: February 4, 2013
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.
Regulatory Roundup for the Week of February 4, 2013
The latest news from the pharmaceutical regulatory community.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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