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 –...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Archive

Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By 

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By 

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 

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

More from Pink Sheet

Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By 

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.