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Biopharmaceuticals

CHMP Recommends EU Approval of Roche’s Itovebi for Advanced Breast Cancer Treatment

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SHERIDAN, WYOMING – May 27, 2025 – Roche has received a significant endorsement from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which issued a positive opinion for Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant. This recommendation positions Roche to offer a first-line treatment solution for adult patients with PIK3CA-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer—an area with limited current treatment options.

Roche and Broad Clinical Labs Join Forces to Advance Next-Gen Sequencing in Neonatal Care

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SHERIDAN, WYOMING – May 27, 2025 – Roche has announced a new strategic collaboration with Broad Clinical Labs, aiming to accelerate the adoption of its next-generation Sequencing by Expansion (SBX) technology, with an initial focus on trio-based whole genome sequencing for critically ill newborns and their biological parents. The partnership signifies a pivotal move in expanding genomics-enabled healthcare and precision medicine at scale.

Columvi Shows Sustained Survival Gains in Aggressive Lymphoma, Validating Roche’s Strategic Oncology Pipeline

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SHERIDAN, WYOMING – May 27, 2025 – Roche has unveiled compelling two-year follow-up data from its pivotal phase III STARGLO trial, reinforcing the long-term clinical value of Columvi® (glofitamab) in combination with chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The results underscore the strategic impact of Roche’s bispecific antibody pipeline in addressing aggressive hematologic malignancies with limited treatment options.

FDA Approves Roche’s Susvimo for Diabetic Retinopathy: A Game-Changer in Retinal Treatment

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SHERIDAN, WYOMING – May 27, 2025 – Roche has received FDA approval for Susvimo® (ranibizumab injection) 100 mg/mL as a new treatment for diabetic retinopathy (DR), marking a pivotal advancement in the battle against this vision-threatening condition that affects nearly 10 million Americans.

Columvi Combination Shows Promising Survival Benefit in Aggressive Lymphoma as FDA Review Progresses

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SHERIDAN, WYOMING – May 27, 2025 – Roche has announced an encouraging update on its supplemental Biologics License Application (sBLA) for Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx), following discussion by the FDA’s Oncologic Drugs Advisory Committee (ODAC). The combination therapy demonstrated a significant 41% reduction in the risk of death in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who are not candidates for autologous stem cell transplant.

FDA Approves Roche’s VENTANA MET (SP44) RxDx Assay as First Companion Diagnostic for Emrelis Treatment in NSCLC

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SHERIDAN, WYOMING – May 27, 2025 – Roche has announced FDA approval of its VENTANA® MET (SP44) RxDx Assay, marking a major milestone in companion diagnostics for non-small cell lung cancer (NSCLC). This approval paves the way for a more precise identification of patients eligible for AbbVie’s Emrelis™ (telisotuzumab vedotin-tllv), a targeted therapy for non-squamous NSCLC with MET protein overexpression.

Enhancing Treatment Precision in Lung Cancer Care

Roche’s Perjeta-Based Regimen Shows 17% Reduction in Mortality in HER2-Positive Early Breast Cancer After 10 Years

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SHERIDAN, WYOMING – May 27, 2025 – Roche has announced compelling final results from the decade-long APHINITY Phase III clinical trial, demonstrating a significant 17% reduction in the risk of death for patients with HER2-positive early-stage breast cancer who received a Perjeta® (pertuzumab)-based adjuvant therapy. These findings reinforce the strategic role of the Perjeta-based regimen in long-term disease management and will be presented as a late-breaking abstract at the 2025 ESMO Breast Cancer Congress.

Danaher’s Beacon Program Accelerates Academic Innovation into Scalable Real-World Impact

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SHERIDAN, WYOMING – May 17, 2025 – Danaher Corporation is reinforcing its position at the forefront of life sciences and diagnostics innovation through its Beacon program—an initiative designed to transform cutting-edge academic research into scalable, market-ready solutions. Spearheaded by Vanessa Almendro, PhD, MBA, Vice President, Head of Science and Technology Innovation at Danaher, the Beacon model exemplifies how strategic academic-industry collaboration can generate high-impact innovations aligned with real-world healthcare and biotechnology challenges.

Danaher’s Science Chief Reaffirms Confidence in Healthcare Innovation Amid Industry Headwinds

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SHERIDAN, WYOMING – May 17, 2025 – Despite facing one of the most turbulent periods since the biotech industry’s inception in the 1970s, Danaher’s Chief Science Officer, Jose-Carlos Gutierrez-Ramos, believes the sector stands on the cusp of unprecedented progress. In a new commentary, Gutierrez-Ramos outlines why the healthcare and life sciences industries should remain optimistic, citing the explosive growth of GLP-1 receptor agonists, a rapidly evolving pipeline in Alzheimer’s research, and the transformative power of artificial intelligence.

Danaher Underscores RNA Medicine Advancements, Urges Continued Industry-Wide Investment

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SHERIDAN, WYOMING – May 17, 2025 – Danaher Corporation is spotlighting the rapid progress and growing potential of RNA medicines, reaffirming its strategic commitment to genomic innovation while calling on industry stakeholders to sustain investment in the field. As RNA therapeutics expand across disease areas and delivery methods, Danaher’s leadership is urging the life sciences ecosystem to double down on momentum at what it describes as a defining moment for RNA-based medicine.

Breakthroughs in RNA Delivery and Safety Optimization