News | July 21, 2021
EMA grants ODD to Saroglitazar Mg
Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC
Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC
As per the agreement, Lonza will provide commercial-scale manufacture of monoclonal antibodies
In addition to supporting the ongoing development of the first IND-approved product in clinical trials, the proceeds will also be used to expand the 3D printed drug product pipeline
ZyCoV-D had already exhibited a robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials
Sun Pharma has committed Rs. 100 crores towards these initiatives
The expanded laboratories and manufacturing facilities at Nansha are expected to come online between Q1 2022 and Q3 2022
The TWYMEEG approval is supported by numerous preclinical and clinical studies, including the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) program managed jointly by both the companies
The company expects to see steady performance led by new launches and gradual normalization post the scale-up in vaccination
The study was conducted in patients with mild to moderate COVID-19
The new platform is the latest initiative under Lupin’s long running umbrella programme, Joint Airways Initiative (JAI), for patients suffering from respiratory ailment
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