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Thermo Fisher Scientific’s Oncomine Dx Target Test Receives US FDA Approval as a Companion Diagnostic

Shots: The US FDA has approved Ion Torrent Oncomine Dx Target Test as a companion diagnostic to identify pts with NSCLC harboring HER2/ERBB2 TKD activating mutations Oncomine Dx Target allows clinicians to identify pts eligible for treatment with Bayer’s HER2-directed therapy Hyrnuo (sevabertinib) for locally advanced or metastatic non-squamous NSCLC Oncomine Dx Target Test, first…

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Thermo Fisher Scientific’s EXENT System Receives the US FDA’s 510(k) Clearance to Aid Multiple Myeloma Diagnosis

Shots: Thermo Fisher Scientific has received FDA 510(k) clearance for the EXENT Analyser & Immunoglobulin Isotypes (GAM) Assay, an automated mass spectrometry-based platform, for aiding diagnosis of MM & related conditions The EXENT System detects & isotypes low-concentration M-proteins with high sensitivity to identify them by molecular weight, differentiating endogenous from therapeutic antibodies & providing…

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Dizal Receives the US FDA’s Accelerated Approval for Zegfrovy (Sunvozertinib) to Treat EGFRm NSCLC

Shots: The US FDA has granted accelerated approval to Zegfrovy for locally advanced or metastatic NSCLC associated with EGFR exon 20 insertion mutations (exon20ins) in pts whose disease has progressed on or after Pt-based CT Approval was based on the multinational WU-KONG1 part B trial assessing Zegfrovy in above mentioned pts, which showed significant improvement…

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Viewpoints_Kindra Whitlatch

Kindra Whitlatch, Product Applications Manager at ThermoFisher Scientific, Shares Insights on Drug Stability Testing

Shots: Kindra talked about the stability testing process and its applications in the pharmaceutical industry She also spoke about the different important parameters for stability testing and the challenges faced during this process The interview gives a deep understanding of ThermoFisher is supporting pharmaceutical and biopharmaceutical manufacturers in the drug stability testing process Smriti: Please discuss…

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PharmaShots Interview Kathy Davy, VP of Oncology at Thermo Fisher Scientific Shares Insights on the Real-World Data from Patients with NSCLC at ASCO 2022

PharmaShots Interview: Kathy Davy, VP of Oncology at Thermo Fisher Scientific Shares Insights on the Real-World Data from Patients with NSCLC at ASCO 2022

Shots: Kathy spoke about the major outcomes from the real-world evidence data presented at the ASCO 2022 Kathy also emphasized on how next-generation sequencing can improve genomic testing The interview gives a view of Thermo Fisher’s vision to bring targeted sequencing that provides faster results for clinicians Smriti: Tell us in detail about the key…

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