CardioMEMS, Inc.
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Latest From CardioMEMS, Inc.
Janssen’s Amivantamab Combo Shows Promise In First-Line NSCLC
Janssen presents highly encouraging interim results at ESMO from the CHRYSALIS study with a combination of amivantamab and lazertinib. Based on the data, the global Phase III MARIPOSA study, which will assess the combo versus blockbuster Tagrisso, will begin next month including in South Korea, home to lazertinib's originator.
FDA Approves Guardant’s Guardant360 CDX Comprehensive Genomic Profile
The liquid-biopsy test is also a companion diagnostic for osimertinib, AstraZeneca’s drug for non-small cell lung cancer.
Guardant Will Collaborate With Janssen On Lung Cancer Companion Diagnostic
The companies expect the Guardant360 CDx liquid-biopsy test to identify patients who will benefit from amivantamab, Janssen’s investigational drug for non-small cell lung cancer.
St. Jude Warning Letter Spotlights CAPA Flaws At CardioMEMS Unit
The warning letter highlights validation and recordkeeping problems at the Atlanta manufacturing facility for the CardioMEMS heart failure remote monitoring system, but it is not expected to affect device availability.