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A REMS by any Other Name

 
• By Michael McCaughan

A new prescription drug for treatment of varicose veins clears FDA. The only dispute in the review: how to handle a remote but real risk of anaphylaxis. A REMS? Not this time…

Quick quiz: There's a new molecular entity pending at FDA, intended for a cosmetic use. There is a clear signal of a risk of anaphylactic reactions, most likely associated with off-label use at high doses. The review team is in agreement: there needs to be some form of communication plan and special monitoring to assure that physicians don't casually use higher doses.

Will the product have a Risk Evaluation & Mitigation Strategy as a condition of approval?

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Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

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Infographic: Leqembi – A Geographical Comparison

 
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The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.