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Biologics Data Protection In Trade Agreements Becoming Key Focus For PhRMA

 
• By Brenda Sandburg

At a House hearing PhRMA representative cites the need for 12 years test data exclusivity for biologics in the Trans-Pacific Partnership Agreement. Separately, USTR issues its 2012 Special 301 Report.

The pharmaceutical industry is calling on members of Congress to support strong intellectual property protections in the Trans-Pacific Partnership Agreement, including 12 years of data protection for biologics.

Roy Waldron, chair of the Pharmaceutical Research and Manufacturers of America’s IP Task Force, made the plea before an April...

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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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Initial Medicare Price Offer For Ozempic, Wegovy Almost Half Off Net, Analysis Suggests

 
• By Cathy Kelly

Only Bausch Health’s Xifaxan may have had a lower initial offer among the 15 drugs in the current Medicare price negotiation round, researchers at the University of Washington and the University of California, San Diego, projected.

Industry Rethinking Visual Elements And Quality-Of-Life Claims After US FDA Drug Ad Crackdown

 
• By Sue Sutter

Sponsors should consider whether their TV commercials contain the same number of scene changes during the major statement as ads that received a violation letter.

Gene Therapy Sponsors Seek More US FDA ‘Platform’ Guidance, Offer Master File Idea

 
• By Michael McCaughan

One clear message from a US FDA listening session on leveraging knowledge across cell and gene therapy products is sponsors want more guidance on how the FDA’s new platform therapy pathway will function.