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...
16:41 , Sep 7, 2018 |  BC Week In Review  |  Clinical News

AZ's anifrolumab misses in Phase III for lupus

AstraZeneca plc (LSE:AZN; NYSE:AZN) and its MedImmune LLC unit said anifrolumab (formerly MEDI-546) missed the primary endpoint in the Phase III TULIP 1 trial to treat systemic lupus erythematosus (SLE). Compared with placebo, anifrolumab failed...
18:15 , Aug 31, 2018 |  BC Extra  |  Clinical News

AZ's anifrolumab misses in Phase III for lupus

AstraZeneca plc (LSE:AZN; NYSE:AZN) and its MedImmune LLC unit said anifrolumab (formerly MEDI-546) missed the primary endpoint in the Phase III TULIP 1 trial to treat systemic lupus erythematosus (SLE). Compared with placebo, anifrolumab failed...
16:43 , Jul 6, 2018 |  BC Week In Review  |  Clinical News

Neovacs planning Phase III for lupus therapy on mixed Phase IIb data

Neovacs S.A. (Euronext:ALNEV) plans to start Phase III testing of lupus candidate IFNalpha-Kinoid despite reporting mixed data from a Phase IIb trial in the indication. IFNalpha-Kinoid is an immunotherapy against interferon (IFN) alpha. The therapy...
15:05 , Jul 3, 2018 |  BC Extra  |  Clinical News

Neovacs planning Phase III for lupus therapy on mixed Phase IIb data

Neovacs S.A. (Euronext:ALNEV) plans to start Phase III testing of lupus candidate IFNalpha-Kinoid despite reporting mixed data from a Phase IIb trial in the indication on Tuesday. IFNalpha-Kinoid is an immunotherapy against interferon (IFN) alpha....
23:52 , Oct 6, 2017 |  BioCentury  |  Finance

Bargain shopping

With all companies valued over $1 billion increasing a median of at least 16.8% in 1H17, investors went bargain shopping in the $500-$999 million tier in 3Q17. The group outperformed all other market cap bands,...
23:50 , Jul 27, 2017 |  BC Week In Review  |  Clinical News

FDA approves GSK's subcutaneous Benlysta for SLE

FDA approved subcutaneous Benlysta belimumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat systemic lupus erythematosus (SLE). GSK said the human mAb against BLyS ( BAFF ; TNFSF13B) is the first subcutaneous, self-injectable therapy that FDA...
19:40 , Jul 21, 2017 |  BC Extra  |  Company News

FDA approves subcutaneous Benlysta formulation

FDA approved a subcutaneous formulation of Benlysta belimumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat systemic lupus erythematosus (SLE). GSK said the human mAb against BLyS ( BAFF ; TNFSF13B) is the first subcutaneous, self-injectable...
20:51 , Feb 9, 2017 |  BC Innovations  |  Translation in Brief

Autoimmunity’s sex bias

It’s well known that autoimmune diseases commonly affect more women than men, but the reason for the bias has been unclear. Now, a University of Michigan team thinks it’s cracked the mystery by pinpointing a...
23:01 , Dec 14, 2016 |  BC Week In Review  |  Clinical News

Subcutaneous Benlysta regulatory update

GlaxoSmithKline submitted an NDA in Japan for IV and subcutaneous Benlysta belimumab to treat active, autoantibody-positive systemic lupus erythematosus (SLE) in adults who have an inadequate response to standard therapy. IV Benlysta -- a human...