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Keep up with the regulator’s latest rulings on novel drugs and expanded indications, as the second half of 2023 promises some major milestone FDA approvals.
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While Amgen and Mirati are widely viewed as frontrunners to win the first front line approval, analysts—and competitors—say the field is still wide open.
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Enterome’s OncoMimics™ Immunotherapy EO2401 Significantly Improves Survival Rate in Recurrent Glioblastoma
11/20/2023
Enterome today announced updated efficacy data from its Phase 1/2 clinical trial of EO2401, in combination with an immune checkpoint inhibitor (nivolumab) +/- an anti-VEGF therapy (bevacizumab), for the treatment of patients with first progression/recurrence of glioblastoma (ROSALIE trial).
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After Bristol Myers Squibb picked up Augtyro as part of its $4.1 billion takeover of Turning Point Therapeutics last year, the ROS1-positive non-small cell lung cancer drug reached the regulatory finish line on Wednesday.
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Mural Oncology Launches to Advance Pipeline of Novel Engineered Cytokine Immunotherapies
11/15/2023
Mural Oncology plc launched as an independent, publicly traded, clinical-stage immuno-oncology company leveraging its core competencies in immune cell modulation and protein engineering to develop novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers.
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Evogene Reports Third Quarter 2023 Financial Results
11/15/2023
Evogene Ltd today announced its financial results for the third quarter period ended September 30, 2023.
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Aethlon Medical Announces Fiscal Second Quarter Financial Results and Provides Corporate Update
11/14/2023
Aethlon Medical, Inc. reported financial results for its fiscal second quarter ended September 30, 2023 and provided an update on recent developments.
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Enterome to Present Updated Data From Phase 1/2 ROSALIE Trial of its Peptide-Based Immunotherapy EO2401 in Recurrent Glioblastoma at SNO 2023
11/13/2023
Enterome announced it will present updated efficacy data from its Phase 1/2 trial of EO2401 in combination with nivolumab +/- bevacizumab, in patients with first progression/recurrence of glioblastoma, in an oral presentation at the Society for Neuro-Oncology 28th Annual Meeting which will be held in Vancouver, British Columbia, Canada on November 15-19, 2023.
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Arbutus Reports Third Quarter 2023 Financial Results and Provides Corporate Update
11/7/2023
Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a cure for people with chronic hepatitis B virus (cHBV) infection, today reported third quarter 2023 financial results and provided a corporate update.
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Scopus BioPharma’s Subsidiary — Duet BioTherapeutics — Presents Compelling New Data for a Novel Treatment for Malignant Glioma at 38th Annual Meeting of the Society for Immunotherapy of Cancer
11/7/2023
Scopus BioPharma Inc. and its majority-owned subsidiary, Duet BioTherapeutics Inc., presented compelling new data that DUET-102 in combination with PD-1 blockade demonstrates significant anti-tumor activity in models of malignant glioma.
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Replimune Reports Fiscal Second Quarter 2024 Financial Results and Provides Corporate Update
11/7/2023
Replimune Group, Inc. announced financial results for the fiscal second quarter ended September 30, 2023 and provided a business update.
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HALOZYME REPORTS THIRD QUARTER 2023 FINANCIAL AND OPERATING RESULTS
11/6/2023
Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the third quarter ended September 30, 2023 and provided an update on its recent corporate activities and outlook.
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Enterome Presents Immune-Monitoring Data on EO2401 at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)
11/1/2023
Enterome announced the presentation of immune-monitoring data from the ongoing trials of EO2401 in adrenal tumors and recurrent glioblastoma at the 38th Society for Immunotherapy of Cancer Annual Meeting taking place from November 1-5, 2023, in San Diego, California, and virtually.
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Amgen Reports Third Quarter 2023 Financial Results
10/31/2023
Amgen announced financial results for the third quarter of 2023.
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European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) in Combination with Cisplatin-Based Chemotherapy for the First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma
10/30/2023
Bristol Myers Squibb announced that the European Medicines Agency has validated its type II variation application for Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, based on results from the Phase 3 CheckMate -901 trial.
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The company on Thursday said it now expects more than $10 billion in new product sales in 2026, despite previously forecasting $10 billion to $13 billion in 2025.
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Bristol Myers Squibb Reports Third Quarter Financial Results for 2023
10/26/2023
Bristol Myers Squibb (NYSE:BMY) today reports results for the third quarter of 2023, which reflect significant pipeline progress and advances in the company's portfolio renewal strategy.
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Zenith Epigenetics Ltd. Announces Collaboration with Cencora on ZEN-3694
10/26/2023
Zenith Epigenetics Ltd. ("Zenith" or the "Company"), a global leader in epigenetics, announced today it has entered into an agreement with Cencora (formerly AmerisourceBergen) aimed at accelerating the commercialization of Zenith Epigenetics' ZEN-3694 program.
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Turbine Establishes Research Collaboration with Ono Pharmaceutical to Identify and Validate Novel Oncology Targets
10/24/2023
Turbine, a computational biology company that deploys empirically validated in silico cell simulations to guide biopharma R&D, announced that it has entered into a collaboration with Ono Pharmaceutical Co., Ltd to identify and validate novel targets within one of Ono’s priority domains of cancer biology.
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The competitors posted promising survival data for their respective blockbuster PD-1 inhibitors—Keytruda and Opdivo—emphasizing the potential of these therapies in bladder cancer patients.