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FDA Lists Guidance Documents Planned for 2013
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Amy Ritter
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FDA has released a list of more than 50 guidance documents planned for 2013.
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European Commission Investigates J&J and Novartis
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Stephanie Sutton
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The European Commission claims that Johnson & Johnson and Novartis may have breached European antitrust rules.
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US Pharmacopeial Convention Announces Revised Official Dates for Elemental Impurities Chapters
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Jennifer Markarian
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Two general chapters on elemental impurities? limits and procedures are to become official Feb. 1, 2013, with implementation proposed for May 1, 2014.
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Shire to Resolve Federal Investigation and Pay $57.5 Million
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Adeline Siew, PhD
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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.
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Pfizer Reports Fourth-Quarter and Full-Year 2012 Financial Results
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Christopher Allen
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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%.
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GSK Increases Stake in Indian Subsidiary
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Stephanie Sutton
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GlaxoSmithKline has increased its stake in its Indian subsidiary, GlaxoSmithKline Consumer Healthcare Ltd, from 43.2% to 72.5%.
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Industry Briefs: February 4, 2013
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A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.
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Regulatory Roundup for the Week of February 4, 2013
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The latest news from the pharmaceutical regulatory community.
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