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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.

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Pipeline Watch: 13 Approvals And 13 Phase III Trial Updates

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.

Vanrafia Approval Plays Into Novartis’s Multipronged IgAN Approach

 
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Orphans Cling On To Growth Advantage As Market Share Heads Towards 20%

 
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Boehringer Still Sees Plenty Of Juice In Jardiance

 
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Strong sales growth for the German group’s SGLT2 inhibitor in 2024

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Executives On The Move: Nine CEOs, Six CMOs And Three CFOs Among This Week’s Changes

Recent moves in the industry include changes at the top at Novo Nordisk and Takeda, plus Nxera Pharma nabs chief commercial officer from AstraZeneca.

Will China’s Retaliatory Tariffs Galvanize Manufacturing Onshoring?

 
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