18:01 , Mar 29, 2019 |  BC Week In Review  |  Company News

FDA rejects Recro's meloxicam NDA for second time

Recro said FDA issued a second complete response letter for its NDA for IV meloxicam (N1539) to manage moderate-to-severe pain. Recro Pharma Inc. (NASDAQ:REPH) said the agency was concerned with onset and duration of IV...
23:51 , Feb 21, 2019 |  BC Week In Review  |  Company News

HaiHe forms joint venture with CSPC, narrows focus to oncology

Shanghai HaiHe Biopharma Co. Ltd. (Shanghai, China) formed a joint venture with CSPC Pharmaceutical Group Ltd. (HKSE:1093) to develop and commercialize five of HaiHe’s programs, mostly outside of oncology. Financial terms were not disclosed. HaiHe...
21:30 , Feb 19, 2019 |  BC Extra  |  Company News

HaiHe forms joint venture with CSPC, narrows focus to oncology

Shanghai HaiHe Biopharma Co. Ltd. (Shanghai, China) formed a joint venture with CSPC Pharmaceutical Group Ltd. (HKSE:1093) to develop and commercialize five of HaiHe’s programs, mostly outside of oncology. Financial terms were not disclosed. HaiHe...
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...
23:33 , Jul 9, 2018 |  BC Extra  |  Politics & Policy

Pain patients zero in on CDC guidelines, side effects

Chronic pain patients said that CDC guidelines and side effects of non-opioid medicines are the major hurdles to accessing effective treatments for their disease. The statements were made at an FDA Patient-Focused Drug Development (PFDD)...
18:23 , Jun 29, 2018 |  BC Week In Review  |  Clinical News

FDA approves CV label update for Pfizer's Celebrex

FDA approved a label supplement for Celebrex celecoxib from Pfizer Inc. (NYSE:PFE) to include data from a postmarketing cardiovascular outcomes trial showing that the lowest approved dose of Celebrex had similar CV safety to that...
16:51 , Jun 8, 2018 |  BC Week In Review  |  Financial News

Sirnaomics raises $25M series C1 round

Sirnaomics Inc. (Gaithersburg, Md.) raised $25 million in an untranched series C1 round led by Yuexiu New Industrial Investment. Fellow new investors Sangel Biomedical Venture Capital, HuaKong Equity Investment and Qianhai Shenghui Investment also participated....
21:16 , Jun 7, 2018 |  BC Extra  |  Financial News

Sirnaomics raises $25M series C1 round

Sirnaomics Inc. (Gaithersburg, Md.) raised $25 million in an untranched series C1 round led by Yuexiu New Industrial Investment. Fellow new investors Sangel Biomedical Venture Capital, HuaKong Equity Investment and Qianhai Shenghui Investment also participated....
17:00 , May 25, 2018 |  BC Week In Review  |  Clinical News

Recro shares crater after CRL for analgesic

Recro Pharma Inc. (NASDAQ:REPH) lost 55% to $5.63 on May 24 after FDA issued a complete response letter for its NDA for IV meloxicam (N1539) to manage moderate to severe pain. The CRL said data...
17:12 , May 24, 2018 |  BC Extra  |  Company News

Recro shares crater after CRL for analgesic

Recro Pharma Inc. (NASDAQ:REPH) lost $6.79 (55%) to $5.63 on Thursday after FDA issued a complete response letter for its NDA for IV meloxicam (N1539) to manage moderate to severe pain. The CRL said data...