21:57 , Sep 21, 2018 |  BC Extra  |  Clinical News

Innovent reports Chinese NET, NSCLC data for PD-1 mAb

Innovent Biologics Inc. (Suzhou, China) presented data this week from neuroendocrine tumor and non-small cell lung cancer cohorts in its Chinese Phase Ib trial of anti-PD-1 mAb sintilimab (IBI308). Data were presented at the Chinese...
21:45 , Sep 21, 2018 |  BC Extra  |  Company News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP Friday recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta Therapeutics (NASDAQ:SRPT) for...
20:38 , Sep 21, 2018 |  BioCentury  |  Politics, Policy & Law

Filling the rebate void

HHS’s proposal to eliminate drug rebates should have the intended consequence of increasing transparency into drug pricing in the short term. But the long view is that value-based pricing or alternative co-pay agreements will do...
17:38 , Sep 21, 2018 |  BC Week In Review  |  Financial News

uBiome moving into therapeutics with $83M series C

Microbiome tech and diagnostic company uBiome Inc. (San Francisco, Calif.) raised $83 million in a series C round led by OS Fund to expand into drug research and development using its patented microbiome assets. Also...
17:36 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

FDA approves Teva's Ajovy, second CGRP inhibitor to prevent migraine

FDA approved Ajovy fremanezumab-vfrm from Teva Pharmaceuticals Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) on Sept. 14 to prevent migraine in adults. The mAb targeting the calcitonin gene-related peptide ligand is the second in its class approved...
16:34 , Sep 21, 2018 |  BC Week In Review  |  Company News

Celenex takeout first of several expected Amicus gene therapy deals

Just weeks after gaining its first FDA approval, Amicus Therapeutics Inc. (NASDAQ:FOLD) has announced its entrance into the gene therapy space with the acquisition of Nationwide Children's Hospital spinout Celenex (Columbus, Ohio) for $100 million...
16:33 , Sep 21, 2018 |  BC Week In Review  |  Financial News

Ex-Kite execs prep quick IPO for CAR T play Allogene

Cell therapy start-up Allogene Therapeutics Inc. (South San Francisco, Calif.) filed to raise up to $100 million in an IPO on NASDAQ underwritten by Goldman Sachs, J.P. Morgan, Cowen and Jefferies. Launched in April with...
16:29 , Sep 21, 2018 |  BC Week In Review  |  Financial News

Ahead of Phase III mucositis study, Galera raises $150M

Galera Therapeutics Inc. (Malvern, Pa.) raised a combined $150 million in a $70 million series C round and $80 million royalty deal led by new investor Clarus. The fund-raising comes ahead of Galera's planned Phase...
16:28 , Sep 21, 2018 |  BC Week In Review  |  Company News

NICE waivers on end of life exception for DLBCL CAR Ts, says Kymriah doesn't meet criteria

Inconsistencies between appraisals by U.K.'s NICE of CAR T therapies emerged Sept. 19 after the committee released draft guidance that said Kymriah tisagenlecleucel from Novartis AG (NYSE:NVS; SIX:NOVN) does not qualify as a life-extending treatment...
11:00 , Sep 21, 2018 |  BC Extra  |  Financial News

uBiome moving into therapeutics with $83M series C

Microbiome tech and diagnostic company uBiome Inc. (San Francisco, Calif.) raised $83 million in a series C round led by OS Fund to expand into drug research and development using its patented microbiome assets. Also...