18:30 , Aug 17, 2018 |  BC Week In Review  |  Clinical News

FDA approves Eisai's Lenvima for first-line HCC

FDA approved Lenvima lenvatinib mesylate from Eisai Co. Ltd. (Tokyo:4523) as first-line treatment of unresectable hepatocellular carcinoma (HCC). The approval was based on data from the Phase III REFLECT trial in patients with previously untreated, metastatic...
18:17 , Aug 17, 2018 |  BC Extra  |  Company News

FDA approves 12-week Eylea regimen after short delay

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA approved an sBLA for an every 12-week dosing schedule of Eylea aflibercept in wet age-related macular degeneration (AMD). The agency's green light comes just days after Regeneron revealed a complete...
17:24 , Aug 17, 2018 |  BC Week In Review  |  Clinical News

Regeneron, Teva’s anti-NGF mAb meets 16-week endpoints in Phase III for OA pain

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) said fasinumab met the co-primary endpoints at week 16 in a substudy of the larger Phase III FACT LTS & OA trial to...
03:31 , Aug 17, 2018 |  BC Week In Review  |  Clinical News

FDA gives green light for Regeneron's 12-week Eylea regimen

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA approved an sBLA for an every 12-week dosing schedule of Eylea aflibercept to treat wet age-related macular degeneration (AMD). Eylea's updated label says patients may be treated with every 12-week...
03:15 , Aug 17, 2018 |  BC Week In Review  |  Clinical News

RegenxBio's AMD gene therapy well tolerated in Phase I

RegenxBio Inc. (NASDAQ:RGNX) said a single subretinal injection of RGX-314 was well tolerated with no treatment-related serious adverse events reported in a Phase I trial to treat wet age-related macular degeneration (AMD). RGX-314 is an...
03:14 , Aug 17, 2018 |  BC Week In Review  |  Clinical News

RXi's subretinal fibrosis therapy well tolerated in Phase I/II

RXi Pharmaceuticals Corp. (NASDAQ:RXII) said RXI-109 was well tolerated with no treatment-related adverse events or dose-limiting toxicities (DLTs) reported in the Phase I/II RXI-109-1501 trial in nine patients with advanced neovascular age-related macular degeneration (AMD)...
03:12 , Aug 17, 2018 |  BC Week In Review  |  Clinical News

Genentech reports Phase II data for sustained delivery eye implant of ranibizumab

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said the majority of patients who received Port Delivery System (PDS) administration of ranibizumab were able to go six months or longer between implantation and the first...
01:46 , Aug 17, 2018 |  BC Innovations  |  Targets & Mechanisms

Unsaturated remyelination

Enzymes downstream in cholesterol biosynthesis could provide new ways to stimulate remyelination that avoid the baggage of previously identified multiple sclerosis targets, according to a group at Case Western. The university is spinning out Convelo...
22:55 , Aug 16, 2018 |  BC Innovations  |  Distillery Therapeutics

Dermatology; pulmonary

INDICATION: Dermatology; pulmonary fibrosis Cell culture and mouse studies suggest inhibiting SHP-2 could help treat dermal and pulmonary fibrosis. In primary human dermal fibroblasts stimulated with the fibrosis mediator transforming growth factor β 1(TGFB1), levels of...
21:24 , Aug 16, 2018 |  BC Extra  |  Clinical News

Regeneron, Teva’s anti-NGF mAb meets 16-week endpoints in Phase III for OA pain

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) said fasinumab met the co-primary endpoints at week 16 in a substudy of the larger Phase III FACT LTS & OA trial to...