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In this ISSUE

Access to Orphan Drugs in Turkey

Priority Review Vouchers Raise Risks, Say FDA

Emergency Disaster Response: Ways Pharma Can Help

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Top Story
Is the Hatch-Waxman System Broken?
The 1984 Hatch-Waxman (HW) Act was intended to be a fair compromise between research-based pharma and the generic companies. Traci Medford-Roscow and Peter C. Richardson write the Act has more than achieved its goals of providing lower-priced generic drugs to the American consumer, but that the goal of incentivizing research and new drug discovery has fallen short ... /Read more/

Regulatory
FDA: More “Me-Betters” and Focused Breakthroughs
OND Director John Jenkins would like to see sponsors invest in more “me-better” drugs—as opposed to “me-too” medicines—to expand treatment options for patients and to boost competition among manufacturers. Jill Wechsler reports ... /Read more/
Advertising
The Creative Impulse: Defending Pharma and Healthg DTC
Defending pharma and health director-to-consumer advertising is a top 2016 priority for the 4A's industry trade group. Mollie Rosen reports ... /Read more/
Sales & Marketing
Reaching the Unreachables
The modern sales and marketing approach has evolved to allow agile commercial organizations to orchestrate delivery of on-demand resources to once unreachable physicians, writes Todd Greenwood ... /Read more/
Calendar
/ January 28–29, 2016: 11th Summit on Biosimilars/
Alexandria, VA.
/ February 18–19, 2016: Bio/Pharma Social Media and Digital Platforms/
Philadelphia, PA.
/ February 23–24, 2016: Speaker Programs 2016/
Philadelphia, PA.
 
Industry update
//Idera Pharmaceuticals (Cambridge, MA, and Exton, PA) announced that Maxine Gowen, Ph.D., joined its Board of Directors, effective January 4, 2016.//Advaxis (Princeton, NJ) has established a Scientific Advisory Board. The Board's founding members are Antoni Ribas, M.D., Ph.D., Jedd Wolchok, M.D., Ph.D., Nancy Freitag, Ph.D., and Marc Lecuit, M.D., Ph.D.//Global Blood Therapeutics (South San Francisco, CA) appointed Scott Morrison to its Board of Directors.//AMAG Pharmaceuticals (Waltham, MA) appointed Nicholas (Nik) Grund as Executive Vice president and Chief Commercial Officer.//Achillion Pharmaceuticals (New Haven, CT) named Joel Barrish, Ph.D., as Chief Scientific Officer (CSO) and Executive Vice President, effective January 4, 2016.//
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