The U.S. Food and Drug Administration (FDA) has approved Xolair (omalizumab) for reducing allergic reactions, including anaphylaxis, that may occur with accidental exposure to foods in individuals aged 1 year and older with IgE-mediated food allergy. This marks a significant milestone as Xolair, produced by Genentech, a member of the Roche Group, becomes the first […]
Genentech, part of the Roche Group, has presented compelling results from the Phase III INAVO120 study, evaluating the effectiveness of inavolisib in combination with palbociclib (Ibrance) and fulvestrant for treating a specific group of breast cancer patients. The study focuses on individuals with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. […]
Pharma giant Roche has secured the U.S. FDA’s approval for Vabysmo (faricimab) in treating macular edema after retinal vein occlusion (RVO). This becomes the third indication for Vabysmo, joining the ranks alongside neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME). Collectively, these three retinal ailments affect an estimated 70 million individuals […]
Switzerland-based Roche has officially declared its acquisition agreement for Telavant Holdings, Inc., a Roivant company collaboratively owned by Roivant Sciences Ltd. and Pfizer Inc. The spotlight of this $7.1 billion deal is on RVT-3101, a novel TL1A directed antibody, poised as a potential game-changer for nearly 8 million global inflammatory bowel disease patients, including those […]
Breaking news in the world of hypertension treatment, Roche and Alnylam Pharmaceuticals have announced the success of their Phase 2 study KARDIA-1. The investigational RNAi therapeutic Zilebesiran met its primary and secondary endpoints in treating adult patients with hypertension. Primary and Secondary Endpoints Achieved Zilebesiran succeeded in significantly reducing systolic blood pressure (SBP) by over […]
Genentech, a Roche Group member, has announced positive results from its Phase III ALINA study evaluating Alecensa (alectinib), setting a new standard for treating early-stage anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Meeting its primary endpoint of disease-free survival (DFS), Alecensa showed a statistically significant and clinically meaningful improvement compared to platinum-based chemotherapy. […]
Actemra FDA approval : Genentech, a subsidiary of Roche, has received the approval of the US Food and Drug Administration (FDA) for Actemra (tocilizumab) intravenous (IV) for the treatment of COVID-19. Actemra intravenous is indicated for the treatment of adult patients who are hospitalized and receiving systemic corticosteroids and supplemental oxygen. Recommended for use as […]