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...
BioCentury | Jan 10, 2020
Emerging Company Profile

NorthSea: Engineering fatty acids for NASH

With its structurally engineered fatty acid platform and a candidate that can hit the three primary mechanisms behind NASH, NorthSea thinks it can succeed in the hepatic and cardiometabolic disease space where so many others...
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...
BC Extra | Jul 2, 2019
Financial News

July 2 Financial Quick Takes: Suspension continues for Woodford fund; plus CRUK, Codiak and Amarin

Woodford extends fund suspension  Woodford Investment Management Ltd. extended to July 29 the suspension of trading in its flagship fund, Woodford Equity Income Fund. The extension’s purpose is to allow the fund manager more time...
BC Week In Review | Mar 22, 2019
Clinical News

Amarin's Vascepa reduces total CV events by 30% in REDUCE-IT

Amarin reported additional data from the Phase III REDUCE-IT trial of Vascepa icosapent ethyl to reduce major adverse cardiovascular events (MACE) showing that the drug led to a 30% reduction in total CV events vs....
BC Week In Review | Nov 16, 2018
Clinical News

Amarin details primary endpoint data for Vascepa, addresses placebo concern

Amarin Corp. plc. (NASDAQ:AMRN) presented detailed primary endpoint data from the Phase III REDUCE-IT trial of Vascepa icosapent ethyl to reduce major adverse cardiovascular events (MACE) and addressed concerns that the mineral oil used in...
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