The U.S. Food and Drug Administration (FDA) has granted approval for Tecentriq Hybreza, the first and only PD-(L)1 inhibitor for subcutaneous injection, developed by Genentech, a member of the Roche Group. This new formulation offers patients a quicker and more flexible cancer treatment option compared to the standard intravenous (IV) infusion. Tecentriq Hybreza is a […]
Phanes Therapeutics, Inc., a clinical-stage biotechnology company dedicated to advancing oncology treatments, has achieved a significant milestone with the granting of Orphan Drug Designation (ODD) for its novel therapy, PT217. The U.S. Food and Drug Administration (FDA) awarded this status to PT217 for its potential in treating neuroendocrine carcinoma (NEC), a particularly aggressive form of […]
In a significant development for the pharmaceutical industry, Dr. Reddy’s Laboratories Ltd. has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) regarding its proposed biosimilar, DRL_RI, also known as ITUXREDI. This endorsement could pave the way for the launch of this promising biosimilar across European […]
Roche Holding AG has finalised its acquisition of LumiraDx’s innovative Point of Care technology, a strategic move aimed at enhancing its diagnostic portfolio and expanding global access to essential healthcare. The completion of this acquisition, following all necessary antitrust and regulatory approvals, marks a significant milestone for Roche as it integrates LumiraDx’s multi-assay point of […]
Roche, a global leader in pharmaceuticals and diagnostics, recently unveiled two-year data from the pivotal Phase III Pagoda and Pavilion studies, showcasing the sustained efficacy and safety of Susvimo in treating two critical diabetic eye conditions: diabetic macular edema (DME) and diabetic retinopathy (DR). These conditions are among the leading causes of vision loss in […]
Roche has announced a significant advancement in diabetes management with the CE Mark approval of its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. This approval paves the way for the deployment of this cutting-edge technology to adults over the age of 18 who are managing their diabetes with flexible insulin therapy. The Accu-Chek SmartGuide CGM […]
Genentech, a key member of the Roche Group, has officially announced the reintroduction of Susvimo (ranibizumab injection) 100 mg/mL, a cutting-edge treatment for wet, or neovascular, age-related macular degeneration (AMD) in the United States. This comes after a voluntary recall and subsequent approval by the U.S. Food and Drug Administration (FDA) of a post-approval supplement […]
Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced disappointing results from the phase II/III SKYSCRAPER-06 study, aimed at evaluating the efficacy of tiragolumab plus Tecentriq (atezolizumab) and chemotherapy in treating non-squamous non-small cell lung cancer. The study did not meet its primary endpoints of progression-free survival (PFS) and overall survival (OS), signaling a setback in […]
Roche (SIX: RO, ROG; OTCQX: RHHBY), a global leader in pharmaceuticals and diagnostics, announced a significant advancement in eye care with the U.S. Food and Drug Administration’s (FDA) approval of the Vabysmo (faricimab) 6.0 mg single-dose prefilled syringe (PFS). This new formulation is approved for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), […]
Roche has revealed promising outcomes from its Phase III STARGLO study, showcasing significant advancements in treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) with Columvi (glofitamab). This study, conducted in collaboration with the Jon and Jo Ann Hagler Center for Lymphoma at the Massachusetts General Hospital Cancer Center, demonstrates that Columvi, when combined with […]