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...
18:26 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

FDA panel to discuss Alkermes' depression candidate

FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will meet Nov. 1 to discuss an NDA from Alkermes plc (NASDAQ:ALKS) for ALKS 5461 as an adjunct to treat major depressive...
16:43 , Sep 21, 2018 |  BC Week In Review  |  Company News

Clovis settling SEC complaint for $20M

The SEC said Clovis Oncology Inc. (NASDAQ:CLVS) will pay more than $20 million in penalties to settle charges that it misled investors about the efficacy of discontinued lung cancer candidate rociletinib. According to SEC's complaint, Clovis...
16:38 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

Innovent's PD-1 inhibitor leads to 68.4% ORR in Phase Ib for first-line NSCLC

Innovent Biologics Inc. (Suzhou, China) reported data from 19 evaluable patients with non-squamous non-small cell lung cancer (NSCLC) in cohort D of a Chinese Phase Ib trial showing that anti-PD-1 antibody sintilimab (IBI308) plus Alimta...
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...
16:25 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

FDA: No new safety concerns for Acadia's PD psychosis drug

Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) rose $4.01 (27%) to $19.11 on Sept. 20, adding more than $500 million in market cap, after an FDA safety review of the company's Nuplazid pimavanserin found postmarketing safety data were...
20:36 , Sep 20, 2018 |  BC Extra  |  Company News

FDA: No new safety concerns for Acadia's PD psychosis drug

Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) rose $4.01 (27%) to $19.11 on Thursday, adding more than $500 million in market cap, after an FDA safety review of the company's Nuplazid pimavanserin found postmarketing safety data were consistent...
00:17 , Sep 15, 2018 |  BioCentury  |  Finance

Hua’s institutional advantage

The same market forces that drove Hua Medicine Ltd. to reduce the size of its Hong Kong IPO tempered participation by retail investors, which could help keep the Shanghai diabetes company’s share price steady amidst...
23:48 , Sep 14, 2018 |  BioCentury  |  Finance

Solidifying Atreca’s repertoire

Atreca Inc. parlayed preclinical proof-of-concept data from its antibody platform into a $125 million series C round, which will enable the cancer immunotherapy company to bring its two lead programs into the clinic. An undisclosed,...
22:58 , Sep 14, 2018 |  BioCentury  |  Regulation

Closing NICE’s Orphan gap

As the list of Orphan drugs rejected by NICE grows, industry and patient groups are pressuring the agency to make broader use of tools that currently apply only to selected ultra-Orphan therapies. These tools allow...