BioCentury | Mar 31, 2020
Product Development

Amarin set to appeal patent ruling that points way to generic competition for Vascepa

Amarin said it will appeal a judge’s patent decision that could blunt the rapid sales growth of cardiovascular drug Vascepa by removing a barrier for generic competition. The ruling, issued after market hours Monday, is...
BC Extra | Jan 13, 2020
Company News

Jan. 13 Company Quick Takes: AZ ends fish oil trial; plus Lynparza, Lilly-NextCure, Innovent, Amgen-Qiagen-Guardant, Axsome-Pfizer

AstraZeneca ends CV outcomes trial of Epanova  AstraZeneca plc (LSE:AZN; NYSE:AZN) discontinued the Phase III STRENGTH trial after an IDMC determined it is unlikely to show that Epanova improved cardiovascular outcomes in patients with mixed...
BC Extra | Dec 27, 2019
Company News

Management tracks: Founder Williams leaving Five Prime to focus on start-up Walking Fish; plus Rubius, Replimune, Invicro, Cerecin, SGI-DNA

Cancer company Five Prime Therapeutics Inc. (NASDAQ:FPRX) said founder Lewis “Rusty” Williams will step down from the board to focus on his role as chairman and CEO of Walking Fish Therapeutics Inc. , a cell therapy...
BC Extra | Dec 14, 2019
Company News

FDA approves Amarin’s Vascepa to reduce CV risk in narrower population

FDA approved Amarin’s Vascepa for cardiovascular risk reduction Friday, though the label is slightly more restrictive than what the company had been aiming for. Shares of Amarin Corp. plc (NASDAQ:AMRN) gained $2.54 (11%) to $26.66...
BC Extra | Dec 2, 2019
Company News

Dec. 2 Regulatory Roundup: Chipscreen’s approval; plus Priority Review for new Imfinzi, Keytruda indications; EMA reviewing Orchard, Amarin candidates; and more

A spate of regulatory news since the start of the Thanksgiving holiday included a drug approval for Chipscreen, a duo of Priority Reviews from FDA, a pair of EMA reviews, and the scheduling of two...
BC Extra | Nov 14, 2019
Company News

FDA panel backs Vascepa CV indication, mixed on broad label

An FDA panel Thursday unanimously supported an expanded label for Amarin's Vascepa to include reduction of cardiovascular risks but could not agree on what population of patients should get the drug. FDA's Endocrinologic and Metabolic...
BC Extra | Nov 12, 2019
Company News

FDA: Mineral oil unlikely culprit in REDUCE-IT outcome

FDA sliced and diced the CVOT data for Amarin’s Vascepa and found little reason to think the mineral oil control arm may have confounded the positive outcome. Now, the agency is asking its Endocrinologic and...
BioCentury | Oct 5, 2019
Finance

Seeking bright spots in 4Q19 amid continued underperformance

Biotech watchers are hoping a busy fourth quarter of data readouts, regulatory actions and IPOs will provide some bright spots to counteract the sector’s continued overall underperformance, which is not expected to improve in 2020....
BC Extra | Sep 13, 2019
Company News

Sept. 12 Company Quick Takes: Atomwise in China deal; plus Ardelyx, GSK, Amarin, deCode

Atomwise, Hansoh in AI drug discovery deal   AI-based drug discovery company Atomwise Inc. (San Francisco, Calif.) has partnered with Hansoh Pharmaceutical Group Co. Ltd. (Jiangsu, China) to design and develop drug candidates against up...
BC Extra | Sep 3, 2019
Company News

Sept. 3 Company Quick Takes: Mundipharma-Cidara, Roche-Spark, Vascepa

Mundipharma licenses rights to Cidara’s rezafungin  Cidara Therapeutics Inc. (NASDAQ:CDTX) granted Mundipharma International Ltd. (Dublin, Ireland) exclusive rights to develop and commercialize rezafungin outside the U.S. and Japan to treat and prevent invasive fungal infections....
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1 - 10 of 490
BioCentury | Mar 31, 2020
Product Development

Amarin set to appeal patent ruling that points way to generic competition for Vascepa

Amarin said it will appeal a judge’s patent decision that could blunt the rapid sales growth of cardiovascular drug Vascepa by removing a barrier for generic competition. The ruling, issued after market hours Monday, is...
BC Extra | Jan 13, 2020
Company News

Jan. 13 Company Quick Takes: AZ ends fish oil trial; plus Lynparza, Lilly-NextCure, Innovent, Amgen-Qiagen-Guardant, Axsome-Pfizer

AstraZeneca ends CV outcomes trial of Epanova  AstraZeneca plc (LSE:AZN; NYSE:AZN) discontinued the Phase III STRENGTH trial after an IDMC determined it is unlikely to show that Epanova improved cardiovascular outcomes in patients with mixed...
BC Extra | Dec 27, 2019
Company News

Management tracks: Founder Williams leaving Five Prime to focus on start-up Walking Fish; plus Rubius, Replimune, Invicro, Cerecin, SGI-DNA

Cancer company Five Prime Therapeutics Inc. (NASDAQ:FPRX) said founder Lewis “Rusty” Williams will step down from the board to focus on his role as chairman and CEO of Walking Fish Therapeutics Inc. , a cell therapy...
BC Extra | Dec 14, 2019
Company News

FDA approves Amarin’s Vascepa to reduce CV risk in narrower population

FDA approved Amarin’s Vascepa for cardiovascular risk reduction Friday, though the label is slightly more restrictive than what the company had been aiming for. Shares of Amarin Corp. plc (NASDAQ:AMRN) gained $2.54 (11%) to $26.66...
BC Extra | Dec 2, 2019
Company News

Dec. 2 Regulatory Roundup: Chipscreen’s approval; plus Priority Review for new Imfinzi, Keytruda indications; EMA reviewing Orchard, Amarin candidates; and more

A spate of regulatory news since the start of the Thanksgiving holiday included a drug approval for Chipscreen, a duo of Priority Reviews from FDA, a pair of EMA reviews, and the scheduling of two...
BC Extra | Nov 14, 2019
Company News

FDA panel backs Vascepa CV indication, mixed on broad label

An FDA panel Thursday unanimously supported an expanded label for Amarin's Vascepa to include reduction of cardiovascular risks but could not agree on what population of patients should get the drug. FDA's Endocrinologic and Metabolic...
BC Extra | Nov 12, 2019
Company News

FDA: Mineral oil unlikely culprit in REDUCE-IT outcome

FDA sliced and diced the CVOT data for Amarin’s Vascepa and found little reason to think the mineral oil control arm may have confounded the positive outcome. Now, the agency is asking its Endocrinologic and...
BioCentury | Oct 5, 2019
Finance

Seeking bright spots in 4Q19 amid continued underperformance

Biotech watchers are hoping a busy fourth quarter of data readouts, regulatory actions and IPOs will provide some bright spots to counteract the sector’s continued overall underperformance, which is not expected to improve in 2020....
BC Extra | Sep 13, 2019
Company News

Sept. 12 Company Quick Takes: Atomwise in China deal; plus Ardelyx, GSK, Amarin, deCode

Atomwise, Hansoh in AI drug discovery deal   AI-based drug discovery company Atomwise Inc. (San Francisco, Calif.) has partnered with Hansoh Pharmaceutical Group Co. Ltd. (Jiangsu, China) to design and develop drug candidates against up...
BC Extra | Sep 3, 2019
Company News

Sept. 3 Company Quick Takes: Mundipharma-Cidara, Roche-Spark, Vascepa

Mundipharma licenses rights to Cidara’s rezafungin  Cidara Therapeutics Inc. (NASDAQ:CDTX) granted Mundipharma International Ltd. (Dublin, Ireland) exclusive rights to develop and commercialize rezafungin outside the U.S. and Japan to treat and prevent invasive fungal infections....
Items per page:
1 - 10 of 490