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Boehringer’s Spesolimab Wins First Approval In Rare Skin Condition

May Commercialize Therapy Alone

 
• By Ayisha Sharma

The German firm’s monoclonal antibody has received a US thumbs-up for a severe skin disease with high unmet need but it must address diagnostic and educational hurdles.    

Start track. Lanes 1, number one of a red racing track.
The US Nod Marks Boehringer's First Major New Drug Approval In Years • Source: Shutterstock

Boehringer Ingelheim GmbH’s spesolimab is the first drug approved for generalized pustular psoriasis (GPP) flares but the niche indication could present challenges surrounding diagnosis and awareness.

The private firm will market spesolimab under the brand name Spevigo following a thumbs-up from the US Food and Drug...

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Bayer’s Elinzanetant Is Latest Drug Hit By FDA Review Delays

 
• By Kevin Grogan

Comes Days After PDUFA Pushback For GSK's Blenrep.

Pipeline Watch: Twelve Approvals And Six 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.

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’

 
• 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.

More from Scrip

EU 15% Tariff Deal Still Leaves Questions For Pharma

 
• By Jessica Merrill

A single 15% tariff rate on imports from Europe includes pharmaceuticals, but it remains unclear if the trade deal will exclude generics or if Trump will offer a grace period.

Roche Unveils Alzheimer’s Phase III Plan And Preclinical Study

 
• By Andrew McConaghie

The trontinemab Phase III study is due to get underway this year, with Roche confident its brainshuttle technology will help it surpass approved rivals.

Bayer’s Elinzanetant Is Latest Drug Hit By FDA Review Delays

 
• By Kevin Grogan

Comes Days After PDUFA Pushback For GSK's Blenrep.