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...
19:59 , Nov 16, 2018 |  BioCentury  |  Tools & Techniques

Benchtop manufacturing gets smaller

Publisher’s note: This story originally ran in the Nov. 15, 2018 issue of...
18:56 , Nov 16, 2018 |  BC Week In Review  |  Company News

ICER: asthma mAbs should be 50% cheaper for cost effectiveness

The Institute for Clinical and Economic Review (ICER) said the costs of five asthma mAbs would need to decrease by at least 50% to be cost effective in a final evidence report . ICER said...
17:55 , Nov 16, 2018 |  BC Week In Review  |  Company News

Daiichi, GSK to dissolve vaccines JV

Daiichi Sankyo Co. Ltd. (Tokyo:4568) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) agreed to dissolve their JV, Japan Vaccine Co. Ltd. In a statement, Daiichi said, “in consideration of changes in the Japan Vaccine business situation, both...
00:10 , Nov 16, 2018 |  BC Extra  |  Financial News

U.K. biopharma stocks weather the Brexit storm

U.K. biopharma stocks held steady Thursday despite the turmoil caused by Brexit negotiations, while the pound lost almost 2% of its value. AstraZeneca plc (LSE:AZN; NYSE:AZN) stock was unchanged in New York on Thursday, and...
22:43 , Nov 15, 2018 |  BC Innovations  |  Tools & Techniques

Benchtop manufacturing gets smaller

MIT scientists continue to break new ground in benchtop manufacturing systems for biologics. Published in...
17:38 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

ViiV's fostemsavir maintains virologic suppression at week 48 in Phase III for HIV

ViiV Healthcare Ltd. (Brentford, U.K.) said fostemsavir plus optimized background therapy maintained virologic suppression of less than 40 copies/mL from week 24 to 48 in 54% of heavily treatment-experienced patients with HIV-1 infection in the...
04:47 , Nov 9, 2018 |  BC Innovations  |  Tools & Techniques

HitGen’s DNA for small molecules

With more than 60 partnerships under its belt, HitGen Ltd. has become a major gateway for companies to access DNA-encoded library technology -- a high efficiency form of combinatorial chemistry that upstages high throughput screening....
23:24 , Nov 7, 2018 |  BC Extra  |  Company News

Management tracks: Myovant, Alkahest

Women’s health and endocrine disease company Myovant Sciences Ltd. (NYSE:MYOV) named Kim Sablich chief commercial officer and Jeff Nornhold SVP of pharmaceutical operations and development. Sablich was VP of primary care marketing in the U.S....
22:10 , Nov 7, 2018 |  BC Extra  |  Preclinical News

GSK’s systemic STING agonist could overcome delivery hurdles

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) researchers have developed a STING agonist that can be delivered systemically as opposed to intratumorally, which can overcome challenges of accessing hard to reach tumors or cancers that have spread. At...