The company will decide how to pursue development program for transplant agent Certican in combination with Neoral by the first week of September, Novartis says. The action letter recommends additional dosing studies of Neoral.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.
The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.
