BioCentury | Mar 29, 2019
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...
BioCentury | Feb 21, 2019
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...
BioCentury | Feb 19, 2019
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...
BioCentury | Dec 8, 2018
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...
BioCentury | Jun 29, 2018
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...
BioCentury | Jun 8, 2018
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....
BioCentury | Jun 7, 2018
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....
BioCentury | May 25, 2018
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...
BioCentury | May 24, 2018
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...
BioCentury | May 9, 2018
Distillery Therapeutics

Musculoskeletal

INDICATION: Muscular dystrophy Mouse studies suggest that COX-2 inhibition could help treat Duchenne muscular dystrophy (DMD). In a mouse model of DMD, the COX-2 inhibitor Celebrex celecoxib decreased immune cell infiltration in tibialis anterior muscle...
Items per page:
1 - 10 of 238