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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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.
The Phase III failure for pevonedistat in three rare blood cancer settings is the third setback for Takeda’s Wave 1 pipeline candidates this year. The NEDD8 inhibitor is still being studied in other settings.
In this week's podcast edition of Five Must-Know Things: GSK’s R&D head departs; Bayer’s pharma R&D chief prioritizes assets; new US launches in atopic dermatitis; is Abivax an M&A target; and China’s gene therapy developers rush to the clinic.