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Lorcaserin Re-Review Expected To Address Risk/Benefit Trade-offs, Rat Tumors

 
• By Emily Hayes

Arena Pharmaceuticals gets new May 10 advisory committee review for its obesity therapy lorcaserin; execs say the recent positive review for competing Qnexa bodes well, and that this time around the risk/benefit profile for lorcaserin is much stronger.

As partners Arena Pharmaceuticals Inc. and Eisai Inc. prepare for a new FDA advisory committee review on May 10 for the weight loss drug lorcaserin, they have the benefit of greater clarity on regulatory policy based on encouraging recent developments for two competing candidates.

The Endocrinologic and Metabolic Drugs Advisory Committee will be considering the resubmission of the candidate after a “complete response” letter...

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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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Lilly’s Price Deal For Mounjaro In UK A Harbinger Of The MFN Future?

 
• By Cathy Kelly

The arrangement, which implies a behind the scenes negotiated discount, may signal a trend toward less price transparency in foreign markets as manufacturers parry Trump’s Most Favored Nation price demands.

GDPR Clarity For Pharma: Industry Code Nears EU-Wide Approval After Six-Year Journey

 
• By Vibha Sharma

The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.

UK Initiative Steps Up Efforts To Tackle Recruitment Bottlenecks In Dementia Trials

 
• By Anabel Costa-Ferreira

A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.