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.
Lilly To Decide Next Steps After Formal FDA 'Nay' For First Chinese PD-1
A Chance To Reflect?
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.
More from New Products
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.
• By
The approval of another Novartis drug with a different mechanism means the company is further cornering multiple parts of IgAN pathogenesis.
• By
It might be the beginning of the end for the orphan drugs party but there is still sales growth enjoyment to be had for the sector, whose star performers are now looking increasingly like mainstream drugs.
• By
Strong sales growth for the German group’s SGLT2 inhibitor in 2024
More from Scrip
• By
By allowing it to enter the brain more easily, trontinemab’s brain shuttle brings more patients to ‘amyloid zero’ levels faster, and with fewer brain swelling side effects.
• By
Compass' bispecific antibody tovecimig hits primary efficacy endpoint in Phase II/III top-line data in advanced biliary tract cancer, and may have class side-effect advantages. But additional survival data may be needed to support US approval.
• By
AstraZeneca remains committed to investing in R&D and alliances in China, where Susan Galbraith, the UK major’s head of oncology R&D, sees innovation eventually reaching parity with the US and Europe.