BioCentury | Nov 7, 2020
Product Development

Amgen’s adaptive solution to lupus

...patient recruitment have slowed progress in lupus. Benlysta belimumab...
BioCentury | Jun 4, 2020
Product Development

With impending Benlysta submission, GSK seeking new paradigm in lupus nephritis treatment

...that although lupus nephritis is a complication of systemic lupus erythematosis (SLE), for which Benlysta belimumab...
...any other indication, while Benlysta is an incumbent in the overall lupus market. Sales of Benlysta...
...see “Three Late-Stage Wins” ). Targets BLyS (BAFF; TNFSF13B) Paul Bonanos, Associate Editor Benlysta, belimumab (GSK1550188, lymphostat-b, IV Benlysta) GlaxoSmithKline...
BioCentury | Dec 18, 2019
Company News

Dec. 18 Company Quick Takes: FDA approves enfortumab vedotin; plus ODAC roundup, Illumina-PacBio, Benlysta, Ultragenyx, Syros-GBT, Xtandi

...competitive threat.” FTC’s announcement follows similar concerns raised by a U.K. agency. GSK eyes expanded Benlysta...
...plc (LSE:GSK; NYSE:GSK) is on track for regulatory submissions in 1H20 seeking to expand Benlysta belimumab’s...
BioCentury | Nov 13, 2019
Clinical News

Three late-stage wins shift the clinical landscape in SLE

...and TNFSF13 to impact development and survival of plasma cells and mature B cells. Benlysta belimumab...
BioCentury | Sep 20, 2019
Company News

Xospata poised for EU approval under accelerated assessment

...first-line advanced renal cell carcinoma in combination with Inlyta axitinib from Pfizer Inc. (NYSE:PFE); Benlysta belimumab...
BioCentury | Aug 29, 2019
Clinical News

New lupus endpoint key to Phase III success for AZ’s anifrolumab

...the second new medicine for lupus in over 60 years. In 2011, FDA approved Benlysta belimumab...
BioCentury | Jul 19, 2019
Company News

July 19 Company Quick Takes: First biosimilars of Avastin, Herceptin launched; plus Gilenya, Celltrion-Nan Fung and Celgene

...plaque psoriasis. Benlysta approved in China for lupus NMPA approved the IV formulation of Benlysta belimumab...
BioCentury | Apr 29, 2019
Company News

April 29 Quick Takes: Takeda, Emendo, ViiV, Zynquista, Benlysta and more

...I diabetes. Benlysta first approved drug in U.S. for children with lupus FDA approved Benlysta belimumab...
BioCentury | Jan 26, 2019
Product Development

Target wide, test narrow in lupus

...IIb SLE 182 Week 24 Dose response based on BICLA (p=0.06) Signal interference GSK’s Benlysta belimumab...
...activity and B cell activity. The only molecularly targeted drug approved for the disease, Benlysta belimumab...
...BAFF; TNFSF13B), and rituximab, which depletes CD20-positive B cells, in Benlysta-refractory patients. According to Tak, Benlysta...
BioCentury | Nov 19, 2018
Regulation

FDA to apply light touch to biopharma apps

...are treated by drugs they manufacture. For example, GlaxoSmithKline plc, manufacturer of lupus treatment Benlysta belimumab...
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