Wockhardt files marketing authorisation application for WCK 5222 with EMA
WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation
WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation
Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD
False positive rates?ranged from 0% to 41%, meaning some labs incorrectly identified bacteria that weren’t present in the sample
The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability
Efdoralprin Alfa was well tolerated, with a safety profile comparable to plasma-derived therapy
The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy
Launches National IVD validation portal and protocols; highlights India’s strengthening health research ecosystem
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