Complexities of Precision Medicine: Managing Multiple Rx/Dx Combos in the Same Class

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...

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Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

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Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.