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Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma 

Shots:  The CHMP has recommended to Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery but do not currently require radiotherapy or CT; anticipated EC decision in all 30 EEA states  The CHMP opinion is based on the global P-III (INDIGO) trial (N=331), which included…

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New Drug Designations - November 2023

New Drug Designations – November 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EMA and China. This month’s report includes 3 biological drugs, 12 small molecules, 13 cell and gene therapies, 1 peptide, 3 exosome-based therapy and 4 devices  Atsena Therapeutics’ capsid AAV.SPR gene therapy, focused on the treatment of Leber congenital…

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PharmaShots Interview Laurent Levy, CEO of Nanobiotix Shares Insights and Clinical Updates on its Nanoparticle Therapy

PharmaShots Interview: Laurent Levy, CEO of Nanobiotix Shares Insights and Clinical Updates on its Nanoparticle Therapy

Shots:  Laurent spoke about the study design of its nanoparticle therapy to enhance the cancer-killing effect of radiation, which was presented at ASCO 2022 Laurent also highlighted how this nanoparticle therapy can be a potential radio enhancer in various tumor types and across lines of therapy The interview summarizes Nanobiotix’s vision to advance nanoparticles across…

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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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