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 met...
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. The...
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 has approved...
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 therapy FDA...
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...
23:01 , Dec 14, 2016 |  BC Week In Review  |  Clinical News

IV 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...