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Shared REMS For Transmucosal Fentanyls Could Expand Market For Meda’s Onsolis As It Exits More Restrictive Program

 
• By Cathy Dombrowski

Class-wide Risk Evaluation and Mitigation Strategy for transmucosal immediate-release fentanyl products will begin operations in March 2012, with participants in REMS for individual products to be transitioned automatically to the new system.

The first shared system to implement a Risk Evaluation and Mitigation Strategy for a class of opioids will begin operating in March 2012 with the debut of the TIRF REMS Access program for transmucosal immediate-release fentanyl products.

FDA on Dec. 29 approved the class-wide REMS for fentanyl drugs requiring out-patient prescribers, pharmacies, wholesalers and distributors to enroll...

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• By Neena Brizmohun

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Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

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• By Cathy Kelly

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• By Urtė Fultinavičiūtė

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

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Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 
• By Anju Ghangurde

Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.

BIO Notebook: PRVs Need To Be A Priority, IPO Window Shut And Focusing On Gene Therapy Safety

 
• By Mandy Jackson and Sarah Karlin-Smith

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Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
• By Dean Rudge

Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.