First approval for Daiichi Sankyo and AstraZeneca’s ENHERTU in China
Clinical studies are expected to start in Q2 2023.
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
This artificial RNA ligase has higher thermostability than natural RNA ligase
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
At commercial scale, Bluestem's patent pending technologies will reduce carbon emission by an estimated 75% or more and be cost-competitive with petroleum based chemicals
The new sterile filling line meets cGMP aseptic filling regulatory requirements
There is a fast resurgence in the transplant activities post COVID
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
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