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FDA Makes It Formal, Rescinds SPA For Amarin’s ANCHOR Study

 
• By Sarah Karlin-Smith

Agency makes clear that triglyceride levels are no longer an acceptable surrogate for reducing cardiovascular risk.

FDA has taken the rare step of formally rescinding Amarin Corp. PLC’s special protocol assessment for the company’s ANCHOR study of its cholesterol-lowering fish oil drug Vascepa (icosapent ethyl).

Amarin is attempting to expand the indication for Vascepa based on the Phase III ANCHOR study, which showed a reduction...

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More from United States

Drug Distributors Face Aug. 27 Deadline For Electronic Exchange Of Product Tracking Data

 
• By Sue Sutter

Compliance deadline comes three months after manufacturers were required to start sending accurate, electronic product tracking data to distributors. The Healthcare Distribution Alliance said its members are ready and it does not anticipate major supply chain issues.

Pharma’s Move Into Direct-To-Patient Sales Facing Legal, Practical and Political Hurdles

 
• By Cathy Kelly

Only a handful programs by pharmaceutical firms are in operation so far. Some companies may be waiting to see if a broad government-facilitated DTC initiative will materialize.

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.

Indegene Exec On DTP Distribution As A ‘Tactical Solution’, Feasibility Of MFN Model

 
• By Anju Ghangurde

Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US, including potentially introducing new intermediaries into the system. Questions on MFN's feasibility and why it may be “catastrophic” to biopharma were also part of the discussion

More from North America

Best Laid Plans: A Chronology Of Post-Pandemic COVID-19 Vaccines

 
• By Bridget Silverman

Quick responses to late-breaking changes to US FDA COVID-19 vaccine policy kept Novavax's Nuvaxovid and Moderna's mNexspike close to expected approval timelines despite revised indications and new post-marketing trial commitments.

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.