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 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…
Shots:
Thermo Fisher has entered into a definitive agreement to acquire Clario, enhancing its digital & data capabilities in clinical research
As per the deal, Thermo Fisher Scientific will acquire Clario for $8.875B in cash, with an additional $125M due in January 2027 & ~$400M in performance-based earnouts for 2026–2027; closing is expected mid-2026, after…
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…
Shots:
The first quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Meanwhile, Selecta and Sobi reported P-III trial (DISSOLVE I & II) results of SEL-212 for chronic refractory gout
Starting with the latest acquisitions, Pfizer acquired Seagen for ~$43B. The first quarter of the year also showcases…
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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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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…
The diagnostic companies continued to serve the high demand for diagnostic testing throughout the COVID-19 pandemic in 2021
Siemens Healthineers, Roche, GE Healthcare, and Abbott were the top players in the race for the global diagnostic companies
PharmaShots has compiled a list of the top 20 diagnostics Companies based on their 2021 revenue in the…

