She will provide strategic advice and scientific leadership to support clients in clinical development, registration strategy, submission, early post-approval strategy
Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)
Phase III trial also demonstrated a statistically significant reduction (14%) in hospitalization for any cause, bringing potential relief for patients and reducing burden on healthcare systems
The company will address the observations within a stipulated timeline working with the regulators
The event is supported by the Ministry of Commerce & Industry, Government of India and CDSCO, Ministry of Health.
This Bioforum will provide the latest insights on delivering increased speed, greater flexibility and enhanced quality while reducing the cost, and risks of navigating the evolving biopharma landscape
Both vaccine candidates demonstrated a favorable safety and tolerability profile similar to the Pfizer-BioNTech COVID-19 Vaccine
States have an important role in ensuring food safety and healthy food practices.
Submission to regulators globally is based on phase 2/3 studies of mRNA-1273 in young children
The event will have a mix of policymakers, national and international leaders from the pharma industry, MSME, innovators, academic and research fraternity
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