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Merus
NEWS

Merus Reports the US FDA’s Accelerated Approval of Bizengri (Zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NSCLC 

Shots:    The US FDA has granted accelerated approval to Bizengri for the treatment of advanced, unresectable or metastatic NRG1+ pancreatic adenocarcinoma or NSCLC. It will be commercialized by Partner Therapeutics in the US under previously signed agreement  Approval was based on eNRGy study assessing the safety, tolerability, PK/PD, immunogenicity & anti-tumor activity of zenocutuzumab to…
December 4, 2024

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J&J
NEWS

Johnson & Johnson Reports the US FDA’s Approval of Rybrevant + Lazcluze as a 1L Treatment of NSCLC with EGFR Mutations 

Shots:     The US FDA has approved J&J’s Rybrevant + Lazcluze as a 1L treatment for LA/metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations  The approval was based on the P-III (MARIPOSA) assessing Rybrevant + lazertinib vs osimertinib and lazertinib alone in 1074 patients  The study reached its 1EP and 2EPs…
August 19, 2024

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Johnson& Johnson
NEWS

Johnson & Johnson Gains the CHMP’s Positive Opinion for Rybrevant (Amivantamab) as a 1L Treatment of NSCLC  

Shots:  The company's Rybrevant + CT (carboplatin & pemetrexed) has gained the CHMP’s positive opinion as a 1L therapy for NSCLC associated with activating EGFR exon 20 insertion mutations   The opinion was based on the P-III (PAPILLON) trial assessing the safety & efficacy of Rybrevant + CT vs CT in NSCLC patients (n=308) with EGFR…
April 26, 2024

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VIEWPOINTS_Sergey Yurasov_2023
VIEWPOINTS

Sergey Yurasov Shares Insights on Initial Dose Escalation Data of BDTX-1535 for the Treatment of Non-Small Cell Lung Cancer Patients

Shots:   During the initial part of conversation, Sergey discussed details about the BDTX-1535 and the trial design of the P-I study where 1535 is being investigated in NSCLC and GBM patients   He then discussed the insights drawn from the first 51 patients recruited in the dose escalation part of the P-I study  In the final…
October 3, 2023

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New Drug Designations - August 2023
INSIGHTS+

New Drug Designations – August 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices  Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…
September 18, 2023

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Viewpoints_Tim Clackson
VIEWPOINTS

Tim Clackson, President & CEO of Theseus Pharmaceuticals, Shares Insights on its Pan-Variant Inhibitor Therapies to Treat Cancer

Shots: Tim spoke about the development of THE-349, a fourth-generation small molecule for the treatment of EGFR-mutant NSCLC Tim also talked about Thesus’ other small molecule, THE-630 in gastrointestinal stromal tumors (GIST) being evaluated in a P-I/II dose-escalation and expansion study  The interview gives an understanding of how Thesus is developing different treatment options to…
November 28, 2022

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Viewpoints_Garret Hampton
VIEWPOINTS

Garret Hampton, President, Clinical Sequencing & Oncology at Thermo Fisher Scientific Shares Insights from the Approval of the First NGS-Based Companion Diagnostic for HER2-Mutant NSCLC

Shots: Garret spoke about the approval of the first NGS-based companion diagnostic to aid in selecting NSCLC patients with HER2  activating mutations for treatment with ENHERTU Garret also talked about the Oncomine Dx Target Test and its availability for different targeted therapies in multiple geographies The interview highlights how Thermo Fisher is working to develop accessible CDx solutions…
October 25, 2022

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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
VIEWPOINTS

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…
July 20, 2022

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