Drug Approval | August 11, 2024
Caplin Point announces completion of unannounced USFDA inspection
The inspection was concluded with zero observations
The inspection was concluded with zero observations
CN201 is a next generation CD3xCD19 bispecific antibody that augments and diversifies Merck’s pipeline, with potential applications in B-cell malignancies and autoimmune diseases
The company reported total income at Rs. 509.8 crore in Q1 FY25 as compared to Rs. 570.3 crore in Q1 FY24
This strong performance was primarily on account of a one-time gain from the strategic collaboration between Biocon Biologics and Eris Lifesciences.
Against targeted investment of Rs. 3,938 crore, investments worth Rs. 4,024 crores have been made under scheme
The drugmaker's net profit slipped 26 per cent on-year to Rs 143.8 crore
The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA
The acquisition of LumiraDx’s Point of Care technology received all required antitrust and regulatory clearances
The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2
Decision on EU marketing authorisation for this population expected by September 2024
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