Columvi is part of Roche's industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approved Lunsumio to treat follicular lymphoma
Laurus will also provide funding for the clinical trials and will launch these products in India and emerging markets
Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma
The company will submit its comprehensive response on these observations to the US FDA
The new range of HDPE bottles is compliant with US FDA, EU regulations and Chinese DMF registration for use in dry pharmaceutical applications
Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.
The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52
The EU certification will support supplies of drug products registered in Europe, from this manufacturing site
Lantern is receiving an exclusive and worldwide option to license intellectual property from Bielefeld University related to the collaboration and IP generated from the collaboration
The collaboration focuses on the development and sharing of Standard Quality and Regulatory Documentation (StaQRD), a standard guide for the electronic transfer of information
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