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Lorcaserin Safety Questions Can Be Answered In Post-Market Study, Panel Tells FDA

 
• By Cathy Dombrowski

FDA’s Endocrinologic and Metabolic Advisory Committee backs approval of Arena’s weight-loss drug 18 to 4 with one abstention. Uncertainty over the risk for heart disease remains a prime concern for panel members.

FDA’s Endocrinologic and Metabolic Advisory Committee continued to have some concerns about the risks associated with Arena Pharmaceuticals Inc.’s weight-loss drug lorcaserin, but opted for post-market monitoring and further study to address the remaining safety issues as it voted 18-4, with one abstention, in favor of approval May 10.

FDA questions to the panel during its second look at lorcaserin focused on the drug’s potential to cause valvulopathy and cancer, and its unknown effects on cardiovascular disease Also see...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.