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Declaring Victory: How FDA Releases REMS

 
• By Michael McCaughan

There is a new category of FDA action letter: a REMS release. Dozens of sponsors of “MedGuide-only” REMS received them after an FDA policy change. But now, FDA is issuing them regularly to sponsors whose communication plans have met their goals – or at least run their course.

It speaks volumes about the current state of Risk Evaluation & Mitigation Strategies that FDA has released more REMS than it has imposed for each of the past two years.

In the fourth year of the REMS era (April 2011-March 2012), that was a function of a policy changed: FDA concluded that a mandatory Medication Guide no longer automatically requires...

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The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

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Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
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US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’

 
• By Francesca Bruce

Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.

Autolus’s Aucatzyl And GSK’s Blenrep Among 10 New Drugs To Get EMA Nod

 
• By Vibha Sharma

The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.

Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 
• By Neena Brizmohun

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.