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Ocaliva Exit Could Help Ipsen And Gilead’s New Cholangitis Entrants

 
• By Andrew McConaghie

The FXR agonist drug is facing market removal in the EU and possibly the US, which could open the door for two new PPAR agonist therapies.

Gilead
Gilead and Ipsen/Genfit's products could benefit from an EU withdrawal of the drug. • Source: Shutterstock

The omens for Advanz Pharma and Intercept’s primary biliary cholangitis treatment, Ocaliva, are not looking good on either side of the Atlantic.

The daily oral treatment is currently licensed for the second-line treatment of the rare autoimmune liver disease, but the European...

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Gilead’s Yeytuo, Lilly’s Kisunla Headline CHMP Positive Opinions

 
• By Alaric DeArment

Yeytuo will have remaining challenges to PrEP to overcome, while Kisunla’s label reflects dosing titration data from a Phase IIIb study to mitigate ARIA-E.

More Pressure on Elevidys As The EU’s CHMP Says ‘No’

 
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Just days after Roche stopped shipments of the DMD gene therapy following safety concerns raised by two patient deaths, its EU approval application has hit a block.

Leo Looks To Grow In US After Hand Eczema Cream Approval

 
• By Kevin Grogan

The Danish medical dermatology specialist doubles boosts its sales force ahead of the launch of Anzupgo.

Pipeline Watch: Five Approvals And Twelve Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

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Deal Watch: Novartis Hopes To Ace Inflammatory Disease With Matchpoint Tie-Up

 
• By Joseph Haas, Lisa Takagi, and Manas Mishra

Plus deals involving Lilly/Gate Bioscience, Concentra/iTeos, Nicox/Kowa, Ajax/Schrodinger, I-Mab/Bridge Health, Otsuka/Cantargia, JCR/Acumen and more.

More Pressure on Elevidys As The EU’s CHMP Says ‘No’

 
• By Alexandra Shimmings

Just days after Roche stopped shipments of the DMD gene therapy following safety concerns raised by two patient deaths, its EU approval application has hit a block.

Executives On The Move: Three New CEOs Among This Week’s Changes

Recent moves in the industry include changes at the top at Trogenix and Quetzal Therapeutics, plus Synendos Therapeutics gains a new CMO from Roche.