Oncology

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Gilead’s Livdelzi FDA Approval for Primary Biliary Cholangitis; Incyte and Syndax’s Niktimvo Approved for Graft-Versus-Host Disease; FDA Lifts Hold on BioNTech and MediLink’s ADC Cancer Trial; FDA Approves IMFINZI for Resectable Lung Cancer; Yutrepia Receives Tentative Approval for PAH and PH-ILD

Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by FDA Gilead Sciences, Inc. has received accelerated approval from the FDA for Livdelzi® (seladelpar) in the treatment of primary biliary cholangitis (PBC). Livdelzi can be used in combination with ursodeoxycholic acid (UDCA) for adults who have not responded adequately to UDCA or as a monotherapy for those who cannot tolerate UDCA. However, it is not recommended for individuals with decompensated cirrhosis. The accelerated approval is supported by the pivotal Phase III RESPONSE study, where 62% of participants treated with Livdelzi met the primary endpoint of a composit...

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X4 Pharmaceuticals’ XOLREMDI FDA Approval; ONO to Acquire Deciphera Pharmaceuticals; Johnson & Johnson’s SIRTURO CHMP Approval; BeiGene’s Tislelizumab EC Approval; Sanofi’s Rilzabrutinib LUNA 3 Phase III Trial

Novartis’ LUTATHERA for GEP-NET Treatment: Ray of Hope for Pediatric Patients

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Ipsen and Skyhawk Therapeutics Partnership; SynOx Therapeutics’ Phase III Trial; Roche’s Alecensa FDA Approval; AbbVie’s RINVOQ Phase III SELECT-GCA Trial; AskBio’s AB-1002 FDA Fast Track Designation

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Roche’s Columvi Phase III STARGLO Trial; Novartis’ Fabhalta Latest Data; Vertex’s Alpine Immune Sciences Acquisition; Telix Pharmaceuticals’ TLX101-CDx Fast Track Designation; NovelMed’s NM5072 Orphan Drug Designation

Personalized vaccine TG4050 induces polyepitopic immune responses against private neoantigens in resected HPV-negative head and neck cancers

ALX Oncology’s Evorpacept Combo Shows Strong Response in Relapsed B-NHL Patients: AACR 2024

Safety and preliminary efficacy of AZD1390 + radiation therapy (RT) for glioblastoma (GBM)

alectinib-promising-efficacy-and-tolerability

Alectinib in children and adolescents with solid or CNS tumors harboring ALK-fusions: Data from the iMATRIX Alectinib Phase I/II open-label, multi-center study

First-in-human dose-expansion study of NBF-006, a novel investigational siRNA targeting GSTP, in patients with KRAS-mutated non-small cell lung cancer

KRYSTAL-1: A pooled phase 1/2 efficacy and safety of adagrasib (MRTX849) in combination with cetuximab in patients with metastatic colorectal cancer (CRC) harboring a KRASG12C mutation

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CTX130 – CAR T Cell Therapy Offers New Hope for Advanced Clear Cell Renal Cell Carcinoma: AACR 2024

Merck’s ADC SKB264 Shows Promising Results in Advanced Gastric Cancer: Phase 2 Data Reveals Potent Anti-Tumor Activity and Manageable Safety Profile ─ AACR 2024 (Abstract CT038)

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Oncology

X4 Pharmaceuticals’ XOLREMDI FDA Approval; ONO to Acquire Deciphera Pharmaceuticals; Johnson & Johnson’s SIRTURO CHMP Approval; BeiGene’s Tislelizumab EC Approval; Sanofi’s Rilzabrutinib LUNA 3 Phase III Trial

Novartis’ LUTATHERA for GEP-NET Treatment: Ray of Hope for Pediatric Patients

Ipsen and Skyhawk Therapeutics Partnership; SynOx Therapeutics’ Phase III Trial; Roche’s Alecensa FDA Approval; AbbVie’s RINVOQ Phase III SELECT-GCA Trial; AskBio’s AB-1002 FDA Fast Track Designation

Roche’s Columvi Phase III STARGLO Trial; Novartis’ Fabhalta Latest Data; Vertex’s Alpine Immune Sciences Acquisition; Telix Pharmaceuticals’ TLX101-CDx Fast Track Designation; NovelMed’s NM5072 Orphan Drug Designation

ENHERTU: Another Triumph to Celebrate for AstraZeneca and Daiichi Sankyo

DOC1021 – Unveiling Hope: Diakonos Oncology’s Breakthrough in Glioblastoma Treatment: AACR 2024

Phase I/II trial of copanlisib in combination with nivolumab for microsatellite stable (MSS) colorectal cancer (CRC)

OBX-115 – TIL Cell Therapy Advancements for ICI-Resistant Advanced Melanoma: AACR 2024

More Views & Analysis

Personalized vaccine TG4050 induces polyepitopic immune responses against private neoantigens in resected HPV-negative head and neck cancers

ALX Oncology’s Evorpacept Combo Shows Strong Response in Relapsed B-NHL Patients: AACR 2024

Safety and preliminary efficacy of AZD1390 + radiation therapy (RT) for glioblastoma (GBM)

Alectinib in children and adolescents with solid or CNS tumors harboring ALK-fusions: Data from the iMATRIX Alectinib Phase I/II open-label, multi-center study

First-in-human dose-expansion study of NBF-006, a novel investigational siRNA targeting GSTP, in patients with KRAS-mutated non-small cell lung cancer

KRYSTAL-1: A pooled phase 1/2 efficacy and safety of adagrasib (MRTX849) in combination with cetuximab in patients with metastatic colorectal cancer (CRC) harboring a KRASG12C mutation

CTX130 – CAR T Cell Therapy Offers New Hope for Advanced Clear Cell Renal Cell Carcinoma: AACR 2024

Merck’s ADC SKB264 Shows Promising Results in Advanced Gastric Cancer: Phase 2 Data Reveals Potent Anti-Tumor Activity and Manageable Safety Profile ─ AACR 2024 (Abstract CT038)

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