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Comparative Effectiveness Research and the Environment for Health Care Decision-Making

 
• By Dan Leonard

During the last five years, there has beenenormous changes in the health care environment: the implementation of the Affordable Care Act and its many provisions, including the creation of PCORI; the development of health exchanges and a move toward value-based payments, most notably in Medicare programs. In the midst of all this change, what impact will comparative effectiveness research have on health care decision-making?

For the last five years the National Pharmaceutical Council has conducted an annual survey that provides a snapshot of health care stakeholders’ perceptions of the key players involved in the comparative effectiveness research (CER) process, from setting priorities to translating and disseminating the research findings.

A few survey findings have become clearer with each year: CER is important, the Patient Centered Outcomes Research Institute (PCORI)...

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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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‘Chubby Labels?’: Generic Entresto Approval Was Lawful, D.C. Appeals Court Finds

 
• By Dean Rudge

MSN Laboratories wins another case against Novartis and will keep approval for its generic version of Entresto. The decision effectively confirms that US FDA can approve ANDA labels that make limited wording changes to carve around patent-protected indications, reinforcing the agency’s flexibility.

EU Pharma Package: Keep Patients Front & Center In Defining Unmet Medical Need

 
• By Francesca Bruce

EU trilogs on the new pharmaceutical legislation will finalize the role patients will take in influencing the development of a new definition of unmet medical need.

CDC Should Boost Vaccine Monitoring Transparency, Communication - National Academies Report

 
• By Sue Sutter

The Immunization Safety Office leveraged a “coordinated network of complementary surveillance systems” to monitor COVID-19 vaccine risks during the pandemic, but its communications faced challenges and were often intertwined with CDC efforts to promote vaccination, NASEM report finds.