Keyword: drug regulation

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U.S. Lawmakers Advance Bill on Prescription Drug Tracking

09.05.2013 - A U.S. House of Representatives panel advanced a bill on Wednesday on how the federal government should track prescription drugs as they move through the distribution chain, over...

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Court Stops EU Regulator Releasing Drug Company Data

30.04.2013 - Europe's medicines regulator has been stopped from releasing clinical trial data about drugs made by AbbVie and Intermune, following a court ruling favouring the two U.S. companies...

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Top U.S. Court to Decide on Deals to Delay Cheaper Drugs

23.03.2013 - The U.S. Supreme Court will hear arguments on Monday over whether big drug companies can settle patent litigation with generic rivals by making deals to keep cheaper products off...

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Biogen Wins EU Backing for Big New MS Drug Hope

22.03.2013 - European regulators have recommended approval of two new multiple sclerosis pills from Biogen and Sanofi, both of which are expected to become major sellers. Friday's decision by...

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Antibiotics Crisis Prompts Rethink on Risks, Rewards

18.03.2013 - Thirty years ago, when the world faced the terrifying prospect of an untreatable disease known as AIDS, big drugmakers scented an opportunity and raced to develop new medicines...

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Pfizer Gets Celebrex Patent Extension

05.03.2013 - U.S. regulators granted Pfizer a reissued patent on its multibillion-dollar Celebrex pain drug that extends its marketing exclusivity until early December 2015, the company said on...

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Switzerland's Roche Pledges to Open Up Access to Drug Data

26.02.2013 - Swiss drugmaker Roche Holding has agreed to expand access to its clinical trial data as the pharmaceutical industry faces calls for greater transparency on scientific data. The...

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US FDA New Drug Approvals Hit 16-Year High in 2012

02.01.2013 - U.S. regulators approved 39 new drugs in 2012, the most in 16 years, suggesting that pharmaceutical makers are poised for growth after losing billions of dollars in recent years to...