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Mifepristone REMS Modifications Likely Violated Administrative Procedure Act, Appeals Court Says

 
• By Nielsen Hobbs

If ruling against US FDA by 5th Circuit is enacted, access to the medication abortion would revert to pre-2016 restrictions, meaning the product would be indicated for a maximum gestational age of forty-nine days and would need to be administered in person.

Mifeprex
• Source: Shutterstock

The mifepristone ruling by the United States Court of Appeals for the Fifth Circuit on 16 August is by no means the last word on access to medication abortion, but it could end up being a definitive one nonetheless.

The appeals court ruling concluded that the REMS modifications that FDA enacted in 2016 – which raised the gestational...

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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.

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
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Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

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The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.

US FTC Continues Effort To Eliminate Orange Book’s Improper Patent Listings

 
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EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.