Drug Approval | September 06, 2021
Accutest enables NMPA approval for Qilu’s Abiraterone
The bioequivalence study was conducted by Accutest Research India, one of the preferred CRO players in India
The bioequivalence study was conducted by Accutest Research India, one of the preferred CRO players in India
The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
The agreement is to develop, manufacture and commercialise biosimilars for the global market.
Trillium’s portfolio includes biologics that are designed to enhance the ability of patients’ innate immune system to detect and destroy cancer cells
FDA approval of the first interchangeable biosimilar insulin will drive the US Insulin biosimilar market, says Kuick Research.
The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.
It strengthens Syngene’s portfolio as a fully integrated custom biomanufacturer with added mammalian and microbial capabilities for clinical and commercial supplies
SAB-185 is currently being evaluated in NIH-sponsored Phase 2/3 adaptive trial
The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial
If approved it will bring a second source of MMR vaccine to the US market
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