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 EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
Pharmaceuticals and Consumer Health report higher sales (Fx & portfolio adj.) and lower earnings
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
Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity
Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept
This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
Campaign launched to spread awareness regarding dengue prevention and control
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