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States Face Harsh Realities of Obamacare
For the 17 states that set up their own state exchanges under Obamacare, finding ways to manage a couple aspects of the new law are turning 2015 into a “Year of Harsh Realities.” Tom Norton explains why.
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Deep Breadth: GSK Doubles Down on COPD and Asthma
Despite a patent expiry in 2010, generic versions of Advair aren't expected to appear on the market for two more years. It took FDA eight years to develop a blueprint for how generics manufacturers might establish an acceptable bioequivalence for Advair, GSK's blockbuster fluticasone propionate/salmeterol xinafoate combo inhaler. Read more
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Q&A: The Future of Clinical Trial Data Sharing
The push to increase transparency of clinical trial data continues to build considerable momentum, amid such factors as the explosion of digital health and new requirements by regulators in the U.S. and Europe to disclose study results to the public Read more
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Turkey Sees Growth in Pharma Market
According to a report unveiled at week's CPhI Istanbul, the pharmaceutical industry in Turkey increased by 8.8% in 2014 on the previous year, with growth in the coming years expected to come mostly from generic drugs. Read more
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Generics Industry Calls for Changes to GDUFA
Prominent generic drug industry groups have called for major changes to the Generic Drug User Fee Act (GDUFA), reports Alexander Gaffney of raps.org this week. Read more
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