Tags : Japan

Pharma

Takeda Enters into an Exclusive License Agreement with Mirum to

Shots: Takeda will lead the regulatory approval and commercialization of maralixibat in Japan & will also be responsible for the development, including conducting clinical studies in cholestatic indications The collaboration will utilize Takeda’s leadership in rare disease, gastroenterology, and hepatology to advance the product in Japan Mirum has submitted a maralixibat’s NDA to the US […]Read More

Biotech

ONO and BMS Report Submission of sBLA for Opdivo (nivolumab)

Shots: The application is based on P-III CheckMate -648 study evaluating Opdivo (3mg/kg, q2w, IV) + Yervoy (1mg/kg, q6w up to 24mos.) or Opdivo + CT vs CT alone in patients with unresectable advanced or recurrent ESCC The results demonstrated an improvement in OS at pre-specified interim analysis in patients with tumor cell PD-L1 expression […]Read More

Regulatory

Astellas and FibroGen’s Evrenzo (roxadustat) Receive EC’s Approval for Symptomatic

Shots: The approval is based on the P-III program including 8 studies evaluating Evrenzo in 9600 patients with symptomatic anemia associated with CKD, regardless of dialysis status & prior ESA treatment. Following the EC’s approval, FibroGen to receive $120M milestones along with royalties based upon EU sales The results demonstrated that the therapy was effective […]Read More