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Companion Drug/Diagnostic Pathway: A Question of Where and Who

 
• By Cole Werble

FDA has put a lot of thought into preparing for the drug/diagnostic companion products that presage the era of personalized medicine; but the lure of fewer controls and less development costs is tugging some of the effort off-shore. FDA is also scaring off small companies from genomic test projects and their VC investors. Is this really an opportunity that is slipping away from the US or just an opportunity only for some participants?

The Food & Drug Administration has the right to be proud of two landmark companion diagnostic approvals in the oncology area this year: Pfizer Inc. ’s Xalkori with an Abbott Laboratories Inc.Vysis FISH Probe Kit for lung cancer and Zelboraf and a companion cobas 4800 BRAF V600 Mutation Test for melanoma, both from Roche.

The approvals show that FDA and sponsors can coordinate the separate regulatory/development efforts of a drug and diagnostic through two...

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

 
• By Neena Brizmohun

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 Nielsen Hobbs

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 Nielsen Hobbs

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

 
• By Francesca Bruce

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

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National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 
• By Bridget Silverman

US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.

US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 
• By Bridget Silverman

Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.

HTA Expert Warns Of Escalating Measures If Pharma Fails To Tame Prices

 
• By Francesca Bruce

Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.