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Amarin Pharma Inc. et al v. West-Ward Pharmaceuticals Corp et al (2:16-cv-02525-MMD-NJK)
Do Teva owe treble damages to GSK? ...
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Amarin Pharma Inc. et al v. West-Ward Pharmaceuticals Corp et al (2:16-cv-02525-MMD-NJK)
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Exactly ... as I said: Mere knowledge (or willful blindness) is not enough ...
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Advancing Phase 1b/2a trial for WVE-003 (SNP3) program in HD; WVE-003 uses new PN backbone chemistry modifications, which demonstrate improved preclinical pharmacology. Wave expects to initiate dosing in a Phase 1b/2a clinical trial for WVE-003 in 2021.
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G
Announcement is imminent
Product name: Vazkepa
EU number: EU/1/20/1524
Active substance: icosapent ethyl
Marketing Authorisation Holder: Amarin Pharmaceuticals Ireland Limited 88 Harcourt Street, Dublin 2, D02DK18, Ireland
ATC:
- Anatomical main group: C - Cardiovascular system
- Therapeutic subgroup: C10 - Lipid modifying agents
- Pharmacological subgroup: C10A - Lipid modifying agents, plain
- Chemical subgroup: C10AX - Other lipid modifying agents
(See WHO ATC Index)
Close date: 29 Mar 2021
Procedure type: Centralised - Authorisation
EMA number: EMEA/H/C/005398/0000
Decision number: (2021)2304 of 26 Mar 2021
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Spot on. Good example.
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Nomen est omen ...
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IIRC
They were suing AZN / EPANOVA as a "lack" of LDL-C increase compared to placebo or baseline*. ('612 patent, 20% LDL-C increase required for non-infringement).
* one of them was more than 20%
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Top of US, Canada and EU Vascepa was approved:
- Lebanon (March 2018, launched: June 2018)
- United Arab Emirates (July 2018, launched: February 2019)
- Qatar (January 2020)
- Bahrain (December 2020)
- Hainan Boao Lecheng International Medical Tourism Pilot Zone (late 2020 / early 2021, launched)
Approval in Mainland China and in Hong Kong are expected to conclude near the end of 2021.
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Nope.
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Budapest, Hungary, March, 26, 2021 (Ihub) – HDGabor today announced that the Europen Commision granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Vazkepa - icosapent ethyl", - marketed by Amarin Corporation plc (NASDAQ:AMRN) - a medicinal product for human use.
European Commission - C(2021)2304 - Register of Commission documents (europa.eu)
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Yes.
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AMRN
Vazkepa approved by the EC
C(2021)2304/F1 SANTE (DG Health and Food Safety) 26/03/2021
Commission implementing Decision
COMMISSION IMPLEMENTING DECISION granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Vazkepa - icosapent ethyl", a medicinal product for human use
https://ec.europa.eu/transparency/regdoc/?fuseaction=list&coteId=3&year=2021&number=2304&version=ALL&language=en
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C(2021)2304/F1 SANTE (DG Health and Food Safety) 26/03/2021
Vazkepa approved by the EC
Just saying ...
COMMISSION IMPLEMENTING DECISION granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Vazkepa - icosapent ethyl", a medicinal product for human use
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G
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