BioCentury | Mar 31, 2021
Regulation

March 31 Quick Takes: Basket of EU approvals includes MS, SMA drugs; plus Amarin, AbbVie, Cara-Vifor

...midst of COVID-19.EU approvals for Vazkepa, Cabometyx, OntozryAlso receiving an approval in the EU was Amarin Corp. plc...
...Generic), Cometriq (Other), Cabometyx (Other) Xcopri, cenobamate (YKP3089) Cara Therapeutics Inc. Vifor Pharma Ltd. AbbVie Inc. Novartis AG F. Hoffmann-La Roche Ltd. Amarin Corp. plc Survival...
BioCentury | Nov 21, 2020
Regulation

Nov. 20 Quick Takes: Approvals in Europe for Alnylam, Alexion therapies; plus FDA priority review for ADC, Sanofi and more

...received the second-level dose of UCARTCS1A died. The company adjusted the clinical protocol to enhance patient safety.Amarin’s...
...amr101, icosapent ethyl, miraxion, AMR-101, LAX-101) Ultomiris, ravulizumab-cwvz (ALXN1210) lumasiran (ALN-GO1) Alexion Pharmaceuticals Inc. Alnylam Pharmaceuticals Inc. Cellectis S.A. ADC Therapeutics S.A. Amarin Corp. plc...
BioCentury | Sep 5, 2020
Product Development

Sept. 4 Quick Takes: HiFiBiO in second cancer deal with Gilead; plus Bridgewest-Pfizer, Amarin, Intercept, Santhera-Idorsia, CMS, Ascendis

...Biotech President and CEO Ian Wisenberg said the deal marks the firm’s first acquisition in Australia.Amarin...
...Amarin’s core patents. Amarin’s stock is down $0.74 (15%) to $4.30 from its Wednesday close (see “Amarin...
...icosapent ethyl, miraxion, AMR-101, LAX-101) Ocaliva, obeticholic acid (DSP-1747, 6ecdca, int-747, oca) Vamorolone (VBP15) Gilead Sciences Inc. Kite Pharma Inc. Amarin Corp. plc Dr...
BioCentury | Jul 10, 2020
Finance

How buysiders are sizing up commercial launches during the pandemic

...drug that was approved in December and launched early this year, Vascepa icosapent ethyl from Amarin Corp. plc...
BioCentury | Mar 31, 2020
Product Development

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

...barrier for generic competition. The ruling, issued after market hours Monday, is likely to cost Amarin...
...several patents protecting the fish oil derivative, the patents themselves are invalid due to obviousness. Amarin Corp. plc...
...an appeal and an injunction preventing the generics’ launch. In a statement issued late Monday, Amarin...
BioCentury | 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

...removes from development a potential competitor to another fish oil-derived therapy, Vascepa icosapent ethyl from Amarin Corp. plc...
...LAX-101) Lynparza, olaparib (AZD2281, KU-0059436, MK-7339) Amgen Inc. Qiagen N.V. Guardant Health Inc. Innovent Biologics Inc. Eli Lilly and Co. [MERGED] AstraZeneca plc Amarin Corp. plc NextCure...
BioCentury | 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

...the neurology company’s board. Zakrzewski also serves on the boards of Acceleron Pharma Inc. (NASDAQ:XLRN), Amarin Corp. plc...
BioCentury | 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...
...label is slightly more restrictive than what the company had been aiming for. Shares of Amarin Corp. plc...
...with elevated triglyceride levels as an add-on to maximally tolerated statin therapy. Following the approval, Amarin...
BioCentury | 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

...fusion protein; tazemetostat targets EZH2. Meanwhile, EMA validated applications from Orchard Therapeutics plc (NASDAQ:ORTX) and Amarin Corp. plc...
...metachromatic leukodystrophy (MLD); the EU review is the first in any territory for the program. Amarin...
...AZD2281, KU-0059436, MK-7339) Zynquista, sotagliflozin (SAR439954, lx4211 tablet) [MERGED] AstraZeneca plc Shenzhen Chipscreen Biosciences Co. Ltd. Merck & Co. Inc. Amarin Corp. plc Orchard...
BioCentury | 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...
...patients should get the drug. FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 that Amarin Corp. plc...
...28. Amarin shares were halted on Thursday. Erin McCallister, Senior Editor Vascepa (amr101, icosapent ethyl, miraxion, AMR-101, LAX-101) Amarin Corp. plc Amarin...
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BioCentury | Mar 31, 2021
Regulation

March 31 Quick Takes: Basket of EU approvals includes MS, SMA drugs; plus Amarin, AbbVie, Cara-Vifor

...midst of COVID-19.EU approvals for Vazkepa, Cabometyx, OntozryAlso receiving an approval in the EU was Amarin Corp. plc...
...Generic), Cometriq (Other), Cabometyx (Other) Xcopri, cenobamate (YKP3089) Cara Therapeutics Inc. Vifor Pharma Ltd. AbbVie Inc. Novartis AG F. Hoffmann-La Roche Ltd. Amarin Corp. plc Survival...
BioCentury | Nov 21, 2020
Regulation

Nov. 20 Quick Takes: Approvals in Europe for Alnylam, Alexion therapies; plus FDA priority review for ADC, Sanofi and more

...received the second-level dose of UCARTCS1A died. The company adjusted the clinical protocol to enhance patient safety.Amarin’s...
...amr101, icosapent ethyl, miraxion, AMR-101, LAX-101) Ultomiris, ravulizumab-cwvz (ALXN1210) lumasiran (ALN-GO1) Alexion Pharmaceuticals Inc. Alnylam Pharmaceuticals Inc. Cellectis S.A. ADC Therapeutics S.A. Amarin Corp. plc...
BioCentury | Sep 5, 2020
Product Development

Sept. 4 Quick Takes: HiFiBiO in second cancer deal with Gilead; plus Bridgewest-Pfizer, Amarin, Intercept, Santhera-Idorsia, CMS, Ascendis

...Biotech President and CEO Ian Wisenberg said the deal marks the firm’s first acquisition in Australia.Amarin...
...Amarin’s core patents. Amarin’s stock is down $0.74 (15%) to $4.30 from its Wednesday close (see “Amarin...
...icosapent ethyl, miraxion, AMR-101, LAX-101) Ocaliva, obeticholic acid (DSP-1747, 6ecdca, int-747, oca) Vamorolone (VBP15) Gilead Sciences Inc. Kite Pharma Inc. Amarin Corp. plc Dr...
BioCentury | Jul 10, 2020
Finance

How buysiders are sizing up commercial launches during the pandemic

...drug that was approved in December and launched early this year, Vascepa icosapent ethyl from Amarin Corp. plc...
BioCentury | Mar 31, 2020
Product Development

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

...barrier for generic competition. The ruling, issued after market hours Monday, is likely to cost Amarin...
...several patents protecting the fish oil derivative, the patents themselves are invalid due to obviousness. Amarin Corp. plc...
...an appeal and an injunction preventing the generics’ launch. In a statement issued late Monday, Amarin...
BioCentury | 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

...removes from development a potential competitor to another fish oil-derived therapy, Vascepa icosapent ethyl from Amarin Corp. plc...
...LAX-101) Lynparza, olaparib (AZD2281, KU-0059436, MK-7339) Amgen Inc. Qiagen N.V. Guardant Health Inc. Innovent Biologics Inc. Eli Lilly and Co. [MERGED] AstraZeneca plc Amarin Corp. plc NextCure...
BioCentury | 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

...the neurology company’s board. Zakrzewski also serves on the boards of Acceleron Pharma Inc. (NASDAQ:XLRN), Amarin Corp. plc...
BioCentury | 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...
...label is slightly more restrictive than what the company had been aiming for. Shares of Amarin Corp. plc...
...with elevated triglyceride levels as an add-on to maximally tolerated statin therapy. Following the approval, Amarin...
BioCentury | 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

...fusion protein; tazemetostat targets EZH2. Meanwhile, EMA validated applications from Orchard Therapeutics plc (NASDAQ:ORTX) and Amarin Corp. plc...
...metachromatic leukodystrophy (MLD); the EU review is the first in any territory for the program. Amarin...
...AZD2281, KU-0059436, MK-7339) Zynquista, sotagliflozin (SAR439954, lx4211 tablet) [MERGED] AstraZeneca plc Shenzhen Chipscreen Biosciences Co. Ltd. Merck & Co. Inc. Amarin Corp. plc Orchard...
BioCentury | 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...
...patients should get the drug. FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 that Amarin Corp. plc...
...28. Amarin shares were halted on Thursday. Erin McCallister, Senior Editor Vascepa (amr101, icosapent ethyl, miraxion, AMR-101, LAX-101) Amarin Corp. plc Amarin...
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