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Zytiga Pre-chemo Data Impress At ASCO, But Early Trial Termination Could Be An Issue

 
• By Shirley Haley

Data from a Phase III trial of Johnson & Johnson’s blockbuster prostate cancer drug Zytiga, which was halted for efficacy in March, were released June 2 at ASCO, but at least one expert in the field questions whether the risk to the eventual clinical results was worth it.

CHICAGO–Data from a trial of Johnson & Johnson’s blockbuster prostate cancer drug Zytiga (abiraterone) in asymptomatic or mildly symptomatic chemotherapy-naïve patients was received with widespread enthusiasm at the American Society of Clinical Oncology annual meeting, but they also raise some concerns about trial design and statistics that likely will raise flags at FDA and draw an advisory committee review.

Results from the Cougar-302 trial, which was stopped after an interim analysis showed significant improvement in progression-free survival for the...

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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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‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By Dean Rudge

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

New EU Filings

 
• By Neena Brizmohun

Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.