Orexigen Agreement On Contrave CV Trial Hints At FDA’s Thinking On Obesity
FDA appears to be testing weight loss agents against an easier-to-meet threshold for cardiovascular risk compared to diabetes drugs, based on Orexigen Therapeutics Inc.’s announcement of an agreement with the agency on a cardiovascular outcomes trial for its obesity agent Contrave (naltrexone/bupropion).
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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.