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Lilly To Decide Next Steps After Formal FDA 'Nay' For First Chinese PD-1

A Chance To Reflect?

 
• By Brian Yang

The official verdict is in for sintilimab and the results are not surprising. But some view the setback for "Made In China" innovation as a chance to reflect and move forward.

FDA Complete response stamp holder
US FDA ISSUES COMPLETE RESPONSE LETTER TO LILLY/INNOVENT'S SINTILIMAB • Source: Nielsen Hobbs; the Pink Sheet | Alamy image

The US Food and Drug Administration has issued an official complete response letter to Eli Lilly and Company for the immuno-oncology agent, Tvvyt (sintilimab), developed by its partner Innovent Biologics, Inc.

The CRL follows an expert committee vote in February that recommended rejecting the approval of the first anti-PD-1 antibody from...

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Japan Results Roundup: Reduced Forex Impact, Uncertain US Tariff Outlook

 
• By Lisa Takagi

Most major Japanese firms report generally positive fiscal first quarter results, led by mainstay growth and despite lower currency effects. But the future impact of any US pharma tariffs remains an overhang.

Insmed Targets $5bn-Plus Market With Brinsupri For Bronchiectasis

 
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In Brief: Bayer Commits Up To $1.3bn For Kumquat’s KRAS G12D Inhibitor

 
• By Mary Jo Laffler

Deal Snapshot: Bayer will take over development of the asset once Kumquat completes a Phase Ia clinical trial, but the biotech firm may opt in to share US profits and losses.