02:43 , Nov 10, 2018 |  BioCentury  |  Regulation

Alkermes adcomm reveals SPCD paradox

Disagreement between FDA and Alkermes plc on how the data were analyzed took center stage at the panel meeting on the depression drug ALKS 5461. But the meeting also flushed out a chicken-and-egg problem for...
17:36 , Sep 28, 2018 |  BC Extra  |  Politics & Policy

FDA promoting master protocols, adaptive trials

Draft guidance documents FDA released Friday on master protocols for oncology drugs and adaptive clinical trial designs are intended to streamline clinical trial development while providing higher quality data to physicians, patients and regulators than...
18:32 , Aug 10, 2018 |  BC Week In Review  |  Company News

FDA reviewers say data are lacking on TIRF drug use

FDA reviewers pointed to significant data gaps for evaluating the REMS program for transmucosal immediate-release fentanyl (TIRF) drugs at a joint advisory committee meeting Aug. 3. Participants gave "important feedback" that insufficient data exists to...
23:07 , Jul 20, 2018 |  BioCentury  |  Regulation

FDA’s positive reinforcement

Companies are still sifting through a half dozen gene therapy guidance documents issued by FDA, but so far it appears the recommendations support the paths taken by some of the most advanced clinical candidates for...
19:08 , May 18, 2018 |  BC Week In Review  |  Company News

FDA names, shames ‘anticompetitive’ drug companies

FDA Commissioner Scott Gottlieb Thursday made public a list of 41 branded drug companies that generics manufacturers have accused of blocking access to drug samples to thwart development of competitive generic drugs. The list includes...
13:30 , May 17, 2018 |  BC Extra  |  Politics & Policy

FDA names, shames ‘anticompetitive’ drug companies

FDA Commissioner Scott Gottlieb Thursday made public a list of 41 branded drug companies that generics manufacturers have accused of blocking access to drug samples to thwart development of competitive generic drugs. The list includes...
01:18 , May 12, 2018 |  BioCentury  |  Finance

HKEX opportunity knocking

The rapid growth of biotech in the greater China region is something Jefferies does not intend to miss. With the opening of a new biotech chapter on the Hong Kong Exchanges and Clearing Ltd. on...
18:15 , May 11, 2018 |  BC Week In Review  |  Clinical News

FDA panel backs volanesorsen approval

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 12-8 to approve Waylivra volanesorsen from Akcea Therapeutics Inc. (NASDAQ:AKCA) to treat familial chylomicronemia syndrome, a rare lipid disorder that results from lipoprotein lipase deficiency. The company...
20:05 , May 8, 2018 |  BC Extra  |  Company News

FDA reviewers question Akcea candidate's safety

FDA reviewers said volanesorsen from Akcea Therapeutics Inc. (NASDAQ:AKCA) will "almost certainly" require a REMS if approved, although even that step "may not be sufficient" to ensure the candidate's safe use due to risks of...
23:25 , Nov 10, 2017 |  BioCentury  |  Regulation

Regulation relocation

Moving EMA’s headquarters hundreds of miles in a 16-month period is a mammoth task, considering it took the agency three years to move addresses from one end of London’s Canary Wharf to another. The move,...