What happens when multiple targeted therapies are approved by FDA, each with a unique companion diagnostic for the same biomarker? The health care system is ill-equipped to deal with that scenario, putting patients at risk if the wrong test is used to guide a treatment decision. Industry has one solution: an analytical comparison of various diagnostic assays, starting with the anti-PD-L1 immunotherapy class.
It may be one of the few downsides of personalized medicine.
The Food & Drug Administration and other stakeholders are concerned that the pharmaceutical industry’s interest in developing targeted therapies – like those that target the PD-1/PD-L1 pathway to treat a variety of cancers – could lead to a complicated post-marketing environment with multiple drugs approved in
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.
