Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
To fund the upfront payment, Biocon Biologics has secured USD 1.2 billion of Sustainability Linked Loan
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.
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