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Amarin Corporation plc

http://www.amarincorp.com

Latest From Amarin Corporation plc

No 'Constraining Situation' On Generic Vascepa API, Says Strides MD

Strides intends to keep US momentum going with Amneal-partnered generic Vascepa, where Hikma and Dr. Reddy’s have filed antitrust suits against Amarin over API supply. Meanwhile, the founder re-iterated ambitious goals set for Stelis and its CDMO business.

Strategy Ingredients

No “Constraining Situation” On gVascepa API Says Strides MD, Q3 Revenues Jump

Strides intends to keep US momentum going with Amneal-partnered generic Vascepa, where Hikma and Dr. Reddy’s have filed antitrust suits against Amarin over API supply. Meanwhile, the founder re-iterated ambitious goals set for Stelis and its CDMO business

Commercial Sales & Earnings

EMA Turns Down Minoryx’s Orphan Drug Nezglyal & Apellis’ Syfovre, OKs Three Others

The European Medicines Agency has recommended against the pan-EU marketing approval of two new medicines, while three others received positive opinions on marketing authorization.

BioPharmaceutical Approvals

US FDA’s Missed User Fee Goals Spiked In 2023 – And Not Just Because Of COVID-19

CDER missed six goal dates among its 2023 novel approvals, reflecting safety concerns as well as pandemic-related inspection delays; Duchenne muscular dystrophy accelerated approval disagreements caused the biologics center’s lone missed goal.

Pink Sheet Perspectives US FDA Performance Tracker
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Company Information

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  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Amarin Pharma
    • Amarin Pharmaceuticals Ireland Limited
    • Laxdale Limited
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