BioCentury | Nov 9, 2020
Regulation

Data Byte: FDA’s NME approvals tally closes in on 2019 count

2020 is on track to be another strong year for FDA approvals of new molecular entities, with 42 approved year-to-date. With two months left in the year, the total is already higher than all but...
BioCentury | Aug 21, 2020
Regulation

Data Bytes: FDA approving new drugs at rapid clip in 2020

This week’s two surprise setbacks for therapies under FDA review are unlikely to derail what is shaping up to be one of FDA’s largest annual classes of new molecular entity approvals. FDA had approved 36...
BioCentury | Jan 25, 2020
Product Development

A milestone year for Roche’s CNS gambit could kick off its plan for the decade

A ramped up focus on CNS that has been long in the making could start to pay off this year for Roche, which has two programs slated for launch and four others with late-stage readouts...
BioCentury | Jan 11, 2020
Finance

Why buysiders say 2020 could be the year of the CNS

A pair of CNS approvals in the final days of 2019 has only added to the growing momentum buysiders were already tracking for 2020 in the once neglected disease area. Positive regulatory signals are converging...
BioCentury | Aug 29, 2019
Product Development

Pharmas want ICH to streamline toxicity requirements for severe diseases

Pharmas have embarked on the long road to developing new ICH guidelines that could expedite patient access to therapies for severe or life threatening diseases by up to three years, calling upon advanced cancer guidance...
BioCentury | Aug 23, 2019
Clinical News

GSK notches clinical win with anti-BCMA ADC amid cancer pipeline push

GlaxoSmithKline's return to cancer took another large step forward as one of its most prominent oncology candidates succeeded in a pivotal Phase II trial to treat multiple myeloma. On Friday, GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said...
BioCentury | Jul 26, 2019
Product Development

Takeda's deals paint a picture of a turnaround in action

With a spate of new and expanded deals this year, Takeda is not letting its $62 billion dollar takeout of Shire slow its transformation from a traditional small molecule company to a home for edgier,...
BioCentury | Jan 8, 2019
Politics & Policy

CHMP recommendations of new active substances up in 2018

EMA said on Friday that the agency's CHMP recommended for approval 42 new active substances in 2018, up seven from 35 in 2017 and its highest total since at least 2013. The recommendations include 11...
BioCentury | Jan 5, 2019
Finance

Ready to launch

The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record year...
BioCentury | Dec 31, 2018
Politics & Policy

FDA closes 2018 with record NME approvals

FDA ended 2018 with a record 59 new molecular entity approvals, up from 46 in 2017. The agency's previous approval record was 53 in 1996, the all-time high in FDA's published data. As of Dec....
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