Genentech and Roche have filed a new patent-infringement lawsuit against Biocon in New Jersey federal court, alleging Biocon’s proposed pertuzumab biosimilar infringes patents covering Perjeta, Roche’s blockbuster HER2-positive breast-cancer treatment, the second major U.S. action against Biocon over the same product in 2026.
Roche’s next-generation KRAS G12C inhibitor, divarasib, has achieved statistical significance in a global head-to-head Phase III trial against sotorasib and adagrasib for advanced non-small cell lung cancer.
Roche has officially announced the launch of AXELIOS 1, a next-generation sequencing platform built on proprietary SBX technology, promising same-day whole-genome sequencing with unprecedented speed and accuracy.
Roche announces FDA Priority Review for giredestrant, the first oral SERD showing positive phase III results in the curative, adjuvant setting for ER-positive early breast cancer.
Roche announces groundbreaking Phase II data for enicepatide and petrelintide ahead of the ADA 2026 Scientific Sessions, positioning its pipeline for best-in-class weight loss and advanced combination therapies.
Roche announces positive top-line Enspryng Phase III results from the METEOROID study, demonstrating a significant delay in relapses for patients with MOGAD.
While Roche’s persevERA trial didn’t meet its primary endpoint, the pharmaceutical company remains committed to advancing giredestrant as a new standard-of-care endocrine therapy. The FDA has accepted the company’s New Drug Application based on positive evERA data, signaling promise for this ER-positive breast cancer treatment.
Roche’s Phase III ALLEGORY trial reveals that Gazyva plus standard therapy helped 76.7% of SLE patients achieve significant clinical improvement. New data published in NEJM highlights Gazyva’s potential to redefine the standard of care in lupus by preventing organ damage and reducing steroid dependency.
Roche’s investigational amylin analog, petrelintide, achieved a statistically significant 10.7% mean body weight reduction in a Phase II trial, offering a well-tolerated alternative to current obesity treatments.
In a landmark announcement, Roche revealed that Gazyva (obinutuzumab) met its primary endpoint in the phase III MAJESTY trial for primary membranous nephropathy treatment. The trial data demonstrates superior clinical outcomes compared to tacrolimus, positioning Gazyva as a transformative therapy for patients with this chronic autoimmune kidney condition. With nearly 88,000 affected patients in the EU and over 96,000 in the US, primary membranous nephropathy represents a significant unmet medical need. Gazyva phase III results show the potential to become the first FDA and EMA-approved therapy specifically for this indication. The positive MAJESTY trial outcomes highlight Gazyva’s mechanism deep tissue B cell depletion via anti-CD20 targeting as an effective approach to halting disease progression and preserving kidney function in primary membranous nephropathy patients.
