Steve joins Sai Life Sciences from GlaxoSmithKline (GSK) where he was a department head and member of the global chemical development leadership team.
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)
The European Commission will review the CHMP recommendation and is expected to make a final decision soon.
Revenue is up 23% whereas Profit After Tax expands 29% for the company
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
The team will also assist the state health departments in terms of public health measures, management guidelines and protocols to manage the increasing cases of Avian Influenza
The CRL did not identify any outstanding scientific issues with the product.
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
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