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Amarin Steps Closer To EU Cardiovascular Risk Market

 
• By Neena Brizmohun

The European Medicines Agency has recommended in favor of approval for Amarin’s fish-oil derivative, Vazkepa.

Anatomy of Human Heart
Vazkepa is for treating patients at high cardiovascular risk • Source: Shutterstock

Amarin Corporation is set to win pan EU-marketing authorization for its fish oil derivative, Vazkepa (icosapent ethyl), for use in the potentially lucrative cardiovascular market.

The European Medicines Agency has recommended that the product be granted approval for reducing the risk of cardiovascular events such...

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More from Europe

Project Orbis: UK Approvals Down Since 2022, But MHRA Touts Advantages

 
• By Eliza Slawther

The UK MHRA has emphasized the merits of the Project Orbis scheme, which has resulted in 12 new drug approvals and 14 indication extensions in the country so far. However, overall annual approval figures were lower in 2023 and 2024 than in the years prior.

US Policy Shift Sparks German Contingency Plans For Accessing ClinicalTrials.gov, PubMed

IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.

UK Must Pay ‘A Little Bit More, A Little Bit Earlier’ For Gene Therapies – CGT Catapult Chief

 
• By Eliza Slawther

If the UK is to become a top three country in the cell and gene therapy space, it must overcome the current political “stumbling block” around making changes that recognize the value of these therapies, Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, tells the Pink Sheet.

Results Reporting: UK Registry To Offer More Flexibility Than US-Based ClinicalTrials.gov

 
• By Vibha Sharma

ISRCTN says its new system for reporting clinical trial results summaries will simplify compliance, and includes features to reduce data entry errors, improve accuracy, enhance accessibility and the reuse of trial results.

More from Geography

Last Minute Course Shifts, Focus On Unknowns: What Sponsors Should Learn From Prasad’s Interventions

 
• By Sarah Karlin-Smith

The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.

GLP-1s In Crosshairs As Employers Worry About Health Costs – And Their Own Reliance On Rebates

 
• By Cathy Kelly

Business Group on Health annual employer survey highlights fast-growing Rx costs, led by the GLP-1 drugs, and payer strategies for controlling them. Policy prescriptions are unclear, though, since employers are loath to leave PBMs and nervous about pending changes to Medicare and Medicaid.

UK Must Pay ‘A Little Bit More, A Little Bit Earlier’ For Gene Therapies – CGT Catapult Chief

 
• By Eliza Slawther

If the UK is to become a top three country in the cell and gene therapy space, it must overcome the current political “stumbling block” around making changes that recognize the value of these therapies, Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, tells the Pink Sheet.