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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 Bags First Global Okay For Hot Flashes Therapy

 
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Lynkuet will compete with Astellas's Veozah/Veoza

In Brief: Soleno To Raise $200m To Boost Vykat XR Launch

 
• By Manas Mishra

Soleno Therapeutics will raise about $200m gross proceeds from an offering of 2.35m of its common stock to fund the commercialization of Vykat XR, which became the first drug for Prader-Willi syndrome to gain US approval on March 26.

Four Chinese Firms Snag Global First-In-Class Approvals In China

 
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J&J Seeks Schizophrenia Relapse Indication For Caplyta

 
• By Jessica Merrill

The company is expecting US FDA approval of the drug in a bigger indication, major depressive disorder, later this year.

More from Scrip

Four Chinese Firms Snag Global First-In-Class Approvals In China

 
• By Dexter Jie Yan

Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.

AbbVie Licenses IGI’s ISB 2001 In Second Myeloma Trispecific Deal For 2025

 
• By Alaric DeArment

IGI CEO Cyril Konto said in an interview that his company picked AbbVie for its agility, drug development acumen and expertise in areas like intellectual property and legal affairs.

Merck & Co. Remains In The BD Game After Verona Takeout

 
• By Jessica Merrill

CEO Rob Davis said the company is in pursuit of more deals as it looks to close the revenue gap looming from the loss of Keytruda in 2028.