Merck receives positive EU CHMP opinion for pembrolizumab plus chemotherapy as first-line treatment for unresectable non-epithelioid MPM
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
Medanta is expected to incur a project capex of ~Rs. 600 crores in next 3-4 years
US Generics grew 5% to Rs. 467 Crores for the quarter
Revenue at Rs 3,623 crore, EBITDA at Rs 718 crore
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
Strengthening focus in Alzheimer's disease and neuroscience pipeline
He has more than 25 years of experience in manufacturing across various industries including petrochemicals, engineering polymers, agrochemicals, organic, and inorganic intermediates
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