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Vytorin: Yesterday’s News?

 
• By Michael McCaughan

Merck’s cholesterol drug is poised to add a unique claim to improve outcomes in as many as 19 million Americans, even though there still isn’t data to answer critics about whether ezetimibe actually adds clinical benefit to conventional statin therapy. Why doesn’t anyone seem to care?

There was plenty of room in the press row during the Endocrine & Metabolic Drugs Advisory Committee’s Nov. 2 meeting to review Merck’s ezetimibe (Zetia/Vytorin) for a new claim to reduce major vascular events in patients with kidney disease.

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PharmaMar Seeks EU Fast-Track Status For ‘Practice-Changing’ ES-SCLC Therapy

 
• By Neena Brizmohun

PharmaMar, which wants to use the Jazz Pharmaceuticals-partnered drug, lurbinectedin, in combination with Roche’s Tecentriq for treating extensive-stage small cell lung cancer, is one of two companies that this month sought an accelerated assessment of their planned EU marketing applications.

‘Come Early, Come Often,’ EMA Chief Tells Industry

 
• By Francesca Bruce

The European Medicines Agency’s chief, Emer Cooke, explained how the agency could help companies with their drug development plans, and said the EU Health Technology Assessment Regulation would help companies design clinical trials that are fit for regulators and HTA bodies.

US FDA Miss On Stealth’s Elamipretide Boosts Signal Of Broader Delays Due To Staff Cuts

 
• By Sue Sutter

Failing to meet the 29 April user fee date for the Barth syndrome treatment, and CDER’s request for a delay in responding to Vanda’s appeal of a tradipitant complete response letter, suggest a slowdown in review work due to layoffs and other recent changes.