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What Belviq Labeling Means For Other Obesity Drug Sponsors

 
• By Cathy Dombrowski

Arena’s Belviq is the first obesity drug approval in over a decade, but it won’t be the only one for long. A look at the FDA-approved labeling for lorcaserin offers a preview of how the agency could handle similar issues for Qnexa and, further down the line, Contrave.  

FDA’s approval of Arena Pharmaceuticals Inc.’s Belviq (lorcaserin) shows that the scales have tipped in the agency’s consideration of the risk-benefit ratio for obesity drugs, and bodes well for Vivus Inc.’s pending Qnexa. How FDA has handled many of the common issues for obesity therapeutics in lorcaserin’s label offers a preview of what could be in store for the other drugs.

Arena’s novel serotonin receptor agonist cleared FDA June 27 as an adjunct to diet and exercise for chronic weight management...

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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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New EU Filings

 
• By Neena Brizmohun

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By Manas Mishra

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.

Could Study Questioning GLP-1 Cost Savings Impact CMMI Demo Chances?

 
• By Cathy Kelly

The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.