01:51 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

Heron's non-opioid HTX-011 gets Priority Review

FDA accepted and granted Priority Review to an NDA for HTX-011 from Heron Therapeutics Inc. (NASDAQ:HRTX) for postoperative pain management. The PDUFA date is April 30. Heron said FDA indicated that it has no plans...
22:04 , Dec 31, 2018 |  BC Extra  |  Company News

Heron's non-opioid HTX-011 gets Priority Review

FDA accepted and granted Priority Review to an NDA for HTX-011 from Heron Therapeutics Inc. (NASDAQ:HRTX) for postoperative pain management. The PDUFA date is April 30. Heron said FDA indicated that it has no plans...
03:14 , Dec 8, 2018 |  BioCentury  |  Regulation

Path to opioid-free pain relief

To jump-start development of analgesics that can help stem the opioid crisis, companies want FDA’s upcoming guidelines to reduce uncertainty around outcomes that constitute clinically meaningful opioid sparing. But while an advisory panel put some...
22:52 , Nov 2, 2018 |  BC Extra  |  Politics & Policy

CMS rule cuts reimbursement for new Part B drugs

Under a new rule, CMS will reimburse newly launched physician-administered drugs covered under Medicare Part B at the wholesale acquisition cost (WAC) plus 3%, down from WAC plus 6%, effective Jan. 1, 2019. Under the...
03:05 , Jun 30, 2018 |  BioCentury  |  Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with...
18:28 , Jun 29, 2018 |  BC Week In Review  |  Financial News

C-Bridge leads Nuance's series B

Nuance Biotech (Shanghai) Co. Ltd. (Shanghai, China) raised $20 million in a series B round led by C-Bridge Capital. Nuance is eligible to receive an additional $15 million from C-Bridge for acquiring new products. Nuance...
21:19 , Jun 28, 2018 |  BC Extra  |  Financial News

C-Bridge leads Nuance's series B

Nuance Biotech (Shanghai) Co. Ltd. (Shanghai, China) raised $20 million in a series B round led by C-Bridge Capital. Nuance is eligible to receive an additional $15 million from C-Bridge for acquiring new products. Nuance...
17:07 , Jun 26, 2018 |  BC Week In Review  |  Company News

Nuance gains Chinese rights to Pacira's Exparel

Pacira Pharmaceuticals Inc. (NASDAQ:PCRX) granted Nuance Biotech Co. Ltd. (Shanghai, China) exclusive rights to develop and commercialize Exparel bupivacaine in China. Pacira is to receive $3 million up front and is eligible for $55 million...
18:27 , Jun 22, 2018 |  BC Week In Review  |  Clinical News

Heron's pain candidate meets in Phase IIb ahead of NDA

Heron Therapeutics Inc. (NASDAQ:HRTX) reported that HTX-011 met the primary endpoint in a pair of Phase IIb trials to treat postoperative pain. Heron intends to submit an NDA to FDA next half for the candidate....
18:57 , Jun 21, 2018 |  BC Extra  |  Clinical News

Heron flying on Phase IIb pain data ahead of NDA

Heron Therapeutics Inc. (NASDAQ:HRTX) added $9.25 (30%) to $39.95 on Thursday after reporting that HTX-011 met the primary endpoint in a pair of Phase IIb trials to treat postoperative pain. The stock move added more...