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Merck KGaA Discontinues Two Cancer Drug Trials After Failures

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Merck KGaA discontinued the Phase III INTR@PID Lung 037 trial for bintrafusp alfa (anti-PD-L1/TGF-beta trap), co-developed with GSK, due to an Independent Data Monitoring Committee recommendation that it would not meet the primary endpoint of progression-free survival in stage IV NSCLC patients with high PD-L1 expression. 1 Merck KGaA also abandoned the Phase III TrilynX trial (NCT04459715) for xevinapant, an IAP antagonist licensed from Debiopharm for $1.08bn, as it was unlikely to achieve the primary endpoint of event-free survival in unresected locally advanced squamous cell carcinoma of the head and neck. 2 No direct mention of SpringWorks in the trial discontinuations; bintrafusp alfa stems from a 2019 GSK collaboration (up to $4.5bn potential), while xevinapant is from Debiopharm. 1 2 Following the announcements, Merck KGaA ADRs fell 1.7% and shares dropped over 10% on Frankfurt exchange; GSK ADRs fell 1.6%. 1 2 Merck continues evaluating bintrafusp alfa in other trials (...

Yale's Craig Crews Builds Model to Guide Biotech Startups Out of Academia's 'Valley of Death'

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FDA's PreCheck Pilot Program: Aligning on Regulatory Pathways to Avoid Approval Surprises

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Theravance Biopharma Halves Workforce and Ends R&D After Phase 3 Failure

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Spotlight On #HTGS26: Agentic AI and Digital Endpoints Supercharging R&D

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Esperion Therapeutics Acquires Corstasis for $75M Upfront to Gain Enbumyst Nasal Spray for Edema

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Hims Pharmacy Partner Plans to Reintroduce GLP-1 Pill Pulled from Market Amid Regulatory Backlash

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Moderna Agrees to Pay Up to $2.25 Billion to Settle COVID-19 Vaccine Patent Dispute with Arbutus and Roivant Subsidiary Genevant

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FDA Fully Lifts Clinical Hold on Intellia Therapeutics' CRISPR Gene Therapy Trials for ATTR Amyloidosis

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Prime Medicine Reverses Course, Seeks FDA Approval for Gene Therapy in CGD After Shelving

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FDA Accelerates Rare Disease Drug Approvals with New Frameworks and Record 2025 Approvals

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3T Biosciences Appoints Rebeca Villarreal-Barragan, MBA, as Head of Clinical Operations

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Orca Bio Presents Clinical Data on High-Precision Cell Therapies at 52nd EBMT Annual Meeting

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