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$MYL and and Biocon, which have co-developed this proposed biosimilar, expect that this may be first MAA for Trastuzumab biosimilar accepted by EMA for review. This filing includes analytical, functional and pre-clinical data, as well as results from pharmacokinetics (PK) and confirmatory efficacy/safety global clinical trials for Trastuzumab.
$WBA is yet to receive US anti-trust clearance for its Rite Aid acquisition. The deadline for the deal expires on January 27.
$BMY plunge 7.2%. No credits to the non-acceleration of approval for lung cancer combination treatment.