21:17 , Dec 14, 2018 |  BC Week In Review  |  Company News

LG Chem and Avacta partner to develop undisclosed targets

Avacta Group plc (AIM:AVCT) granted LG Chem Ltd. (KRX:051910) exclusive, global rights to develop Affimer candidates against multiple undisclosed targets to treat inflammatory disorders and cancer. Avacta may receive up to $180 million in up...
20:04 , Dec 14, 2018 |  BC Week In Review  |  Company News

France's ANSM creates pathways to shorten clinical trial approval times

The French National Agency for Medicines and Health Products Safety (ANSM) implemented two Fast Track approval pathways on Oct. 15 to speed authorization of clinical trials. The pathways aim to shorten clinical trial application approval...
01:21 , Dec 8, 2018 |  BioCentury  |  Strategy

Novo gets serious about AI-guided drug design

Novo Nordisk A/S is fashioning its R&D makeover to integrate artificial intelligence across its drug discovery and development process, after a pilot program delivered the cost and time savings the pharma was looking for. In...
22:02 , Dec 6, 2018 |  BC Week In Review  |  Clinical News

Stoke unveils Dravet data that supported $90M series B

Stoke Therapeutics Inc. (Bedford, Mass.) presented the preclinical data for its Dravet syndrome antisense oligonucleotide (ASO) therapy that CEO Ed Kaye said helped it raise its $90 million series B round in October. In a...
14:49 , Dec 4, 2018 |  BC Extra  |  Preclinical News

Stoke unveils Dravet data that supported $90M series B

Stoke Therapeutics Inc. (Bedford, Mass.) presented the preclinical data for its Dravet syndrome antisense oligonucleotide (ASO) therapy that CEO Ed Kaye said helped it raise its $90 million series B round in October. In a...
04:50 , Nov 30, 2018 |  BC Innovations  |  Targets & Mechanisms

Revving up metabolism at ASH 2018

Cancer metabolism is a prominent theme at this year’s ASH meeting, with researchers broadening the tent from metabolic targets that drive hematologic malignancies to those that intersect with other hot topics, notably immuno-oncology and epigenetics....
22:28 , Nov 27, 2018 |  BC Extra  |  Politics & Policy

Cross-party call for May to guarantee cooperation with EMA post-Brexit

Conservative and opposition members of the U.K. Health and Social Care Select Committee have pushed Prime Minister Theresa May’s government for guarantees that the U.K. will be able to closely cooperate with EMA following the...
00:42 , Nov 27, 2018 |  BC Extra  |  Politics & Policy

CMS takes aim at protected drug classes, allowing step therapy, exclusions

Just as the Obama administration before it, HHS Secretary Alex Azar and the Centers for Medicare & Medicaid Services unveiled a proposed rule change on Monday that would target drugs in protected therapeutic classes, allowing...
13:51 , Nov 19, 2018 |  BioCentury  |  Regulation

FDA to apply light touch to biopharma apps

Concerned that regulatory uncertainty is preventing biopharma companies from developing digital tools that could help patients manage their health, FDA plans to exempt a broad range of apps and other software from premarket review. In...
03:21 , Nov 17, 2018 |  BioCentury  |  Product Development

Betting Combos on Biomarkers

Despite lackluster monotherapy data at SITC from the latest tranche of immunotherapy candidates, drug developers are moving into combination trials with PD-1 and PD-L1 inhibitors based on biomarkers of pharmacodynamic activity. Results from the next...