| October 30, 2014 | ISSUE NUMBER 375 VOL 4 |
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Global Health
More Incentives for Ebola Drug Development, Urge Legislators
Leading Senators are proposing legislation to add Ebola to the list of diseases eligible for priority review vouchers from the FDA as an incentive for biopharma companies to invest in treatments for this deadly disease. The priority review voucher program for neglected tropical diseases currently applies to 16 deadly conditions that afflict millions of people in developing countries, but Ebola is not yet on FDA’s list. Jill Wechsler reports ...Read more
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Europe
EMA’s Clinical Data Disclosure Proposals Under Fire
The European Medicines Agency really is stuck between a rock and a hard place. It might have expected that its latest proposals — the publication this month of its plan for proactive release of clinical reports — would receive a warm welcome. But the outcome is far from a roaring success, writes Reflector ...Read more
Rare Diseases
Investment Pros Remain Bullish on Orphans
Access to capital could not be better for companies developing for orphan indications, said an executive in J.P. Morgan’s Healthcare Investment Banking Group, speaking at the National Organization for Rare Disease’s Rare Diseases and Orphan Products Breakthrough Summit in Alexandria, Virginia, last week. Casey McDonald reports ...Read more
Rare Diseases
Expanded Access: Myths, Truth and Behavior
In another lively discussion at NORD’s National Organization for Rare Disease’s Rare Diseases and Orphan Products Breakthrough Summit last week, Kay Holcombe, Senior Vice President, Science Policy at Biotechnology Industry Organization pointed out that, with regard to expanded access, not all companies are big, that small companies are scared, and that myths are driving behavior
...Read more
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 //Cesca Therapeutics (Rancho Cordova, CA) has announced it is to embark on a nationwide search for a new CEO. Robin C. Stracey, currently a member of the company's Board of Directors, will serve as interim CEO pending the new hire.//Oliver Fetzer, Ph.D., has resigned as President and CEO of Cerulean Pharma (Cambridge, MA).//Loxo Oncology (Stamford, CT) announced the promotion of Jennifer Low, M.D., Ph.D. to Chief Medical Officer and the appointment of Lori Kunkel, M.D. as a non-employee member of the Board of Directors.//Catalyst Pharmaceutical Partners (Coral Gables, FL) appointed David J. Caponera to the newly created position of Vice President, Patient Advocacy and Reimbursement.// |
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 Slow growth in developed economies or a slowdown in high growth markets: which concerns you the most?
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