Tags : Submission

COVID-19 Regulatory

Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273

Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing the safety and immunogenicity of two vaccinations of TAK-919 (100μg, given 28 days apart) in 200 participants aged ≥20yrs. followed through 12mos. after the second vaccination. Takeda has completed enrollment […]Read More


Astellas and Seagen Reports Submission of Two BLA to the

Shots: The first BLA submission is based on P-III EV-301 trial which involves assessing of Padcev vs CT in 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based CT and a PD-1/L1 inhibitor. The 1EP of the study was OS The second BLA submission is based on P-II cohort […]Read More


YL Biologics Reports the NDA Submission of YLB217 (biosimilar product

Shots: YLB reported the NDA filing of YLB217, a biosimilar product of long-acting erythropoiesis-stimulating agent Nesp, which YLB solely developed, was executed through Yoshindo On Sept 08, 2017, YLB signed a technology transfer agreement with CJ Healthcare, including exclusive development and marketing rights for Nesp biosimilar and started domestic development with the sponsorship of Yoshindo […]Read More