AstraZeneca's Atacand Heart Failure Indication Clears FDA Ahead Of Cmte. Review

The agency approves candesartan for treatment of heart failure to reduce cardiovascular mortality and hospitalizations. The angiotensin receptor blocker is the first product in its class to receive the claim. Approval comes two days before an FDA advisory panel review.

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

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.

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Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
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President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.

US FDA Advisory Committee Misperceptions Abound … At HHS

 

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.