Budesonide CRL Another Setback For Takeda’s ‘Wave 1’ Pipeline
Setback for company's near-term launch goals and US patients with rare esophageal inflammatory condition as regulator asks for additional clinical data.
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The French major has secured a fourth approval, in eosinophilic esophagitis, for Dupixent, while the EMA is set to make Sanofi's enzyme replacement therapy, Xenpozyme, the first drug approved in Europe for acid sphingomyelinase deficiency.
Japan's largest pharma firm logs what was generally viewed by analysts as a solid fiscal third quarter, driven by growth for its portfolio of global products, leading to raised guidance for the full year despite one pipeline setback. There will also be multiple C-suite reshuffles come 1 April.
Maribavir is the first antiviral agent targeting and inhibiting the pUL97 protein kinase, as well as Takeda's second new molecular entity approved by FDA this year.