Oncology

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

IMFINZI’s AEGEAN Phase III Trial Data for Treating Resectable NSCLC; Ipsen and Day One’s Exclusive Agreement to License and Market Tovorafenib Outside the US; Alzheimer’s Drug LEQUEMBI Rejected by EU; EU Apporves Pfizer’s Gene Therapy DURVEQTIX; CHMP Approves SPEVIGO’s New Indications

The FDA Advisory Committee Considers the AEGEAN Phase III Trial Data in their Review of IMFINZI for Treating Resectable NSCLC The FDA's Oncologic Drugs Advisory Committee (ODAC) acknowledged that AstraZeneca’s IMFINZI (durvalumab) achieved the primary endpoint of event-free survival (EFS) in resectable non-small cell lung cancer (NSCLC) based on the AEGEAN Phase III trial. This trial involved adult patients with early-stage (IIA-IIIB) NSCLC treated with Imfinzi and neoadjuvant chemotherapy before surgery, followed by Imfinzi as adjuvant monotherapy. The FDA accepted the supplemental Biologics License Application (sBLA) for this indication in September 2023, with re...

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Partner Trial ─ Neoadjuvant Olaparib Disappoints in BRCA Wild-Type TNBC: AACR 2024

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AstraZenca’s Saruparib Shows Promise as First-in-Class PARP1-Selective Inhibitor in HRR-Deficient Breast Cancers: AACR 2024

Clinical activity of P-BCMA-ALLO1, a B-cell maturation antigen (BCMA) targeted allogeneic chimeric antigen receptor T-cell (CAR-T) therapy, in relapsed refractory multiple myeloma (RRMM) patients (pts) following progression on prior BCMA targeting therapy

Atezolizumab: Investigating Immunotherapy in Head and Neck Squamous Cell Carcinomas (HNSCC) – AACR 2024

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AstraZeneca and Daiichi Sankyo’s Enhertu US Approval; Basilea’s ZEVTERA FDA Approval; Genmab’s ProfoundBio Acquisition; Rocket Pharmaceuticals’ RP-L102 EMA Approval; Alexion’s Ultomiris and Soliris AAN 2024 Data

Initial results from an open-label phase 1b/2 study of RP1 oncolytic immunotherapy in solid organ transplant recipients with advanced cutaneous malignancies (ARTACUS)

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Regeneron Presents Positive Pivotal Data on Linvoseltamab for Relapsed/Refractory Multiple Myeloma at AACR Annual Meeting 2024

C2Dx’s Shaw Scalpel System; Texas Original’s RSO Gummies; Abbott’s Whole Blood Rapid Test FDA Clearance; Medtronic’s TAVR Device FDA Clearance; Nexalin’s Device Improved Symptoms; CYduct Diagnostics’ Positive Study Results

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AstraZeneca’s Voydeya FDA Approval; Akebia’s Vafseo FDA Approval; Bristol Myers Squibb’s Phase III YELLOWSTONE Trial Update; Astellas’ IZERVAY FDA Approval; AstraZeneca’s Truqap and Faslodex MHLW Approval

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Advances in Non-Muscle Invasive Bladder Cancer Treatment: Exploring Emerging Therapies

Potential of EGFR Inhibitors: A Promising Avenue in Cancer Treatment

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Regeneron’s Odronextamab BLA; Novo Nordisk’s Cardior Pharmaceuticals Acquisition; Novartis’ Fabhalta CHMP Approval; Idorsia’s TRYVIO FDA Approval; AbbVie’s Landos Biopharma Acquisition

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Analysis & Perspective

Oncology

IMFINZI’s AEGEAN Phase III Trial Data for Treating Resectable NSCLC; Ipsen and Day One’s Exclusive Agreement to License and Market Tovorafenib Outside the US; Alzheimer’s Drug LEQUEMBI Rejected by EU; EU Apporves Pfizer’s Gene Therapy DURVEQTIX; CHMP Approves SPEVIGO’s New Indications

Partner Trial ─ Neoadjuvant Olaparib Disappoints in BRCA Wild-Type TNBC: AACR 2024

AstraZenca’s Saruparib Shows Promise as First-in-Class PARP1-Selective Inhibitor in HRR-Deficient Breast Cancers: AACR 2024

Clinical activity of P-BCMA-ALLO1, a B-cell maturation antigen (BCMA) targeted allogeneic chimeric antigen receptor T-cell (CAR-T) therapy, in relapsed refractory multiple myeloma (RRMM) patients (pts) following progression on prior BCMA targeting therapy

Atezolizumab: Investigating Immunotherapy in Head and Neck Squamous Cell Carcinomas (HNSCC) – AACR 2024

AstraZeneca and Daiichi Sankyo’s Enhertu US Approval; Basilea’s ZEVTERA FDA Approval; Genmab’s ProfoundBio Acquisition; Rocket Pharmaceuticals’ RP-L102 EMA Approval; Alexion’s Ultomiris and Soliris AAN 2024 Data

Initial results from an open-label phase 1b/2 study of RP1 oncolytic immunotherapy in solid organ transplant recipients with advanced cutaneous malignancies (ARTACUS)

Regeneron Presents Positive Pivotal Data on Linvoseltamab for Relapsed/Refractory Multiple Myeloma at AACR Annual Meeting 2024

Inoculating Hope: The Landscape of Cancer Vaccination

More Views & Analysis

A Closer Look at Nectin-4 Targeted Therapies: Preclinical Insights – AACR 2024

Advancements in Targeting KRASG12D: Preclinical Insights and Therapeutic Potential

C2Dx’s Shaw Scalpel System; Texas Original’s RSO Gummies; Abbott’s Whole Blood Rapid Test FDA Clearance; Medtronic’s TAVR Device FDA Clearance; Nexalin’s Device Improved Symptoms; CYduct Diagnostics’ Positive Study Results

AstraZeneca’s Voydeya FDA Approval; Akebia’s Vafseo FDA Approval; Bristol Myers Squibb’s Phase III YELLOWSTONE Trial Update; Astellas’ IZERVAY FDA Approval; AstraZeneca’s Truqap and Faslodex MHLW Approval

Advances in Non-Muscle Invasive Bladder Cancer Treatment: Exploring Emerging Therapies

Potential of EGFR Inhibitors: A Promising Avenue in Cancer Treatment

Regeneron’s Odronextamab BLA; Novo Nordisk’s Cardior Pharmaceuticals Acquisition; Novartis’ Fabhalta CHMP Approval; Idorsia’s TRYVIO FDA Approval; AbbVie’s Landos Biopharma Acquisition

Unveiling the Potential of TROP-2 Inhibitors: A New Frontier in Cancer Treatment

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