SHERIDAN, WYOMING – June 12, 2025 – Genentech, a biotechnology powerhouse and subsidiary of Roche, has confirmed the layoff of 143 employees at its South San Francisco headquarters, marking the latest phase in a year-long operational reshaping. The company disclosed the reduction via a Worker Adjustment and Retraining Notification (WARN), with job terminations set to take effect on July 14.
SHERIDAN, WYOMING – June 12, 2025 – In a strategic move signaling regulatory reform and modernization, FDA Commissioner Marty Makary and CBER Director Vinay Prasad have outlined a new four-year roadmap for the agency in The Journal of the American Medical Association (JAMA). Their article, “Priorities for a New FDA,” introduces a reform-focused agenda that emphasizes accelerated drug approval timelines, generative AI implementation, and a renewed focus on cost transparency and public health outcomes.
SHERIDAN, WYOMING – June 1, 2025 – Roche has announced compelling final overall survival data from its phase III INAVO120 study, showing that the Itovebi™ (inavolisib)-based regimen reduces the risk of death by more than 30% in patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. The findings were presented at the 2025 ASCO Annual Meeting and simultaneously published in the New England Journal of Medicine.
First PI3K Inhibitor to Prolong Survival in This Breast Cancer Subtype
SHERIDAN, WYOMING – June 1, 2025 – Roche has announced compelling new data from its ongoing FENopta open-label extension study, confirming that its investigational therapy fenebrutinib continues to provide sustained disease suppression in patients with relapsing multiple sclerosis (RMS) for up to two years.
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.
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.
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.
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.
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.
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