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Thermo Fisher’s Oncomine Dx Target Test Gets FDA Green Light as Companion Diagnostic for Servier’s Voranigo
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US pharmaceutical and biotechnology company Thermo Fisher Scientific (NYSE: TMO) has received marketing approval from the US Food and Drug Administration (FDA) for its Ion Torrent Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals’ Voranigo (vorasidenib) tablets. Voranigo, the first…
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Thermo Fisher Faces FDA Scrutiny Over Syringe Air Bubble Protocols at North Carolina Plant
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Thermo Fisher Scientific’s (NYSE: TMO) Greenville, North Carolina, facility has come under scrutiny after a US Food and Drug Administration (FDA) inspection revealed certain production procedure issues, including the monitoring and measurement of air bubbles within syringes, according to a Form 483 document obtained by Reuters. The inspection was part…
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Bayer and Thermo Fisher Partner to Develop Rapid Companion Diagnostics for Precision Oncology
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Germany’s Bayer (NYSE: BAYE) has entered into a strategic partnership with U.S. life sciences leader Thermo Fisher Scientific (NYSE: TMO) to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx) aimed at enhancing precision cancer therapies. Financial terms of the collaboration remain undisclosed. According to the press release, the diagnostic tests…
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Thermo Fisher Scientific Expands Partnership with Sangon Biotech to Include GC/MS
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US-based life sciences giant Thermo Fisher Scientific Inc., (NYSE: TMO) has announced an expansion of its strategic partnership with China-based contract research organization (CRO) Sangon Biotech. This development builds upon their initial agreement signed in August 2023, which now encompasses gas chromatography-mass spectrometry (GC/MS) in addition to the gene science…
