The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
To co-develop and co-commercialize MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager, worldwide except for Japan where Merck retains exclusive rights
The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU
Revolutionary technology will further boost OneSource’s scientific services offerings
The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA
Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia
Strong topline growth driven by solid performance across key brands.
More emphasis should be given on investing healthcare resources towards prevention of diseases rather than only focusing on diagnostic and therapeutic options
The product is bioequivalent and therapeutically equivalent to the reference listed drug
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