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Latest From Energy Partners Ltd.
The Greatest FDA Advisory Committees, Part II: The Birth Of The ‘Pazdur Moment’
With landmark advisory committee meetings coming up, we take a look back at some of the memorable panel meetings over the last 20 years. This is Part II in the series.
New CEO Dodd Up For The Task Of Turning Around Aeterna Zentaris
David Dodd assumed the role of chief executive at the Canadian oncology company in April and has clear plans to create a revenue stream that will help finance its portfolio of oncology candidates.
The New Out-Licensing Start-Ups: Securing Product Supply
A new crop of companies deals head-on with Big Pharma's biggest out-licensing problems--transaction cost and the "embarrassment factor." Solving both involves strategies to make the extra work of out-licensing worthwhile for their large partners. In particular, after years of resisting the idea, they're now allowing their Big Pharma partners the right to buy back the compounds, usually after clinical proof of concept.
Hurry Up and Wait: The Slowdown in Accelerated Approvals
Accelerated approvals are decelerating. Sponsors argue the FDA is so caught up in the current emphasis on safety that they're raising the AA efficacy standards. The FDA contends that the companies who have been rejected aren't meeting the efficacy standards or performing the promised follow-up trials. Is the FDA changing the rules-or are companies themselves bending them? A look at several recent cases of AA therapies reveals that both are true.
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