PGI Drug Discovery LLC (PsychoGenics), recognized for its phenotypic drug discovery platform, has announced an exclusive license agreement with Roche. This agreement grants PsychoGenics global rights to develop, manufacture, and commercialize RO7117997, an Equilibrative Nucleoside Transporter 1 (ENT1) inhibitor, which is IND-ready. A Promising Candidate for Neuropsychiatric Disorders Discovered through a partnership utilizing PsychoGenics’ AI-enabled […]
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. […]
Lupin Limited announced today that it has secured approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Pirfenidone Tablets, 267 mg and 801 mg. These tablets are the generic equivalent of Esbriet Tablets, a product of Hoffmann La Roche Inc. The tablets will be manufactured […]
Roche is teaming up with Eli Lilly and Company (Lilly) to support the development of its Elecsys Amyloid Plasma Panel (EAPP) blood test which has been designed by the former to enable the earlier diagnosis of Alzheimer’s disease. According to Roche, to deal with the strain that Alzheimer’s disease has on healthcare systems, it is […]
Lunsumio FDA approval : Genentech, a subsidiary of the Roche Group, has secured the approval of the US Food and Drug Administration (FDA) for Lunsumio (mosunetuzumab-axgb) for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL) in adults, subjected to two or more treatments for their cancer. Lunsumio is a CD20xCD3 T-cell engaging bispecific […]
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 […]
Alembic Pharmaceuticals has secured final approval for its abbreviated new drug application (ANDA) for Ketorolac Tromethamine Injection USP, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL (30 mg/mL) Single Dose Vials from the US Food and Drug Administration (FDA). The product is the generic version of Roche’s Toradol Injection, 15 mg/mL, 30 mg/mL, and 60 […]