22:01 , Feb 1, 2019 |  BioCentury  |  Politics, Policy & Law

Focusing on cures

A Massachusetts Institute of Technology-led consortium is finalizing pilot programs that are intended to serve as models for overcoming two major hurdles to implementing performance-based contracts for curative therapies in the United States. The goal...
00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
14:39 , Dec 11, 2018 |  BC Extra  |  Politics & Policy

FDA considering easing use of foreign references for biosimilars

FDA announced new policies to boost the U.S. market for biosimilars Tuesday, and said it is considering easing rules that make it difficult and expensive for biosimilars manufacturers to use biologics manufactured outside the U.S....
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Draft guidance documents FDA released Friday on master protocols for oncology drugs and adaptive clinical trial designs are intended to streamline clinical trial development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...