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With announcements pouring in since the beginning of this year, FDA’s fourth and newest expedited approval pathway for medicines has begun to bear fruit. Established in 2012 within the FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designations have so far totaled 25 as of the end of July.

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In the spirit of lawn chair cogitation and hammock-spun reverie, Pharm Exec invites you to submit your own verses-pharma-related, of course-to be published on our website in late August.

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The trade media is ablaze with lurid accounts of bribery, tax fraud, and other illicit promotional activities in China-ironically, the country touted as guarantor of our industry's future.

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On Friday, the New England Health Institute (NEHI), outlined six “Priorities for Action” to help steer the solution to better medication adherence in the US.

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Being an observer rather than a participant in the drugs business makes it easier to sense those defining moments when something fundamental has changed, a limit is reached, and a new order emerges to reset the basic license to operate.

The National Institute for Health and Care Excellence (NICE) will have a vital role in the post 2014 value-based pricing (VBP) world. The Department of Health (DH), which still acts as the sponsor organization for the agency, has set out in more detail just what value assessment by NICE will need to do. Now NICE has to determine the methods and set up the governance and workable processes to deliver it.

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The ink is not yet dry on the European Union’s Horizon 2020 agreement to invest some €70 billion ($92 bn) in research over the next seven years, and already contenders for funding are jostling for attention.

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Recently, there was a bit of a dust-up over whether it was appropriate for the Secretary of Health and Human Services (HHS) to engage the National Football League (NFL) to help HHS with the process of drumming-up enrollment for health insurance exchanges. In the end, the NFL and other sports leagues decided they were not going to be involved fearing the appearance of taking political sides.

Scientific opinion has special protection under the First Amendment, but does that give pharma a free pass to BYOD – build your own dataset – publish a peer-reviewed article based on the data, and then promote it for competitive advantage?

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With the FDA holding its first patient-focused drug development meeting in October of last year, regulators are starting to take notice of the impact disease-based organizations can have in improving drug trial design for new therapies-particularly for rare diseases

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Joe Ganley, Director of State Government Affairs at McKesson, spoke earlier this year on public health policy and its implications for patient adherence. Here, he provides PharmExec with some highlights of that presentation.

Click here to scan the metrics-including sales growth and gross margins-that PharmExec used to assess company performance and decide on this year's industry audit winner.

William Looney introduces this year's selection of 15 pharma professionals that, on our view, have real prospects for a future key to the C-suite.

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Our lead feature this month on 15 new Emerging Pharma Leaders is a window into what makes our publication unique. In 2007, Pharm Exec began a systematic annual search to identify and highlight those men-and women-that in our purely editorial view had real prospects for a future key to the "c suite." Two of our early choices-Sanofi's Chris Viehbacher and Heather Bresch of Mylan-have made it to the very top, as CEO.

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I read a blog post recently where Brian S. McGowan, PhD, predicted 50 percent of medical meetings will be replaced by virtual courses within five years. I don’t know about the number, but the logic is probably right. I’m sure a lot of CME can be delivered as well online as it can in person, possibly better.