Nice, France – Roca Therapeutics (Roca), a pioneer in non-invasive, first-in-class therapies for severe ocular diseases, today announces the granting of Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for its lead clinical candidate, RCT002, in the treatment of Radiation Maculopathy. This regulatory milestone is the result of Roca’s...
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MISSISSAUGA, ON – Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on March 5, 2024, the Institut National d’Excellence en Santé et en Services Sociaux (INESSS) recommended Columvi® (glofitamab for injection) for public reimbursement. This recommendation follows the recent positive recommendation from the Canadian Agency for Drugs and...
The VENTANA TROP2 (EPR20043) RxDx Device is an immunohistochemistry (IHC) assay combined with a digital pathology algorithm to determine patient treatment. The device uses artificial intelligence-based image analysis with a level of diagnostic precision not possible with traditional manual scoring methods. This Breakthrough Device Designation (BDD) demonstrates Roche’s continued...
Roche Diagnostics today announced the launch of a new tuberculosis test for South Africa. Worldwide, South Africa is one of the countries with the highest prevalence of tuberculosis. The new kit detects different species of Mycobacterium from human sputum samples using the LightCycler® 2.0 Instrument. The diagnosis of tuberculosis in...
Basel, Switzerland – Roche (SIX: RO, ROG; OTCQX: RHHBY) presents new data for OCREVUS® (ocrelizumab) and the investigational Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain (24-26 September). New data show that treatment...
After a thorough clinical review, the benefit-risk for the use of Elevidys in non-ambulatory patients with Duchenne has been re-assessed, following two cases of fatal acute liver failure Effective immediately, dosing of non-ambulatory patients, irrespective of age, is paused in the clinical setting; dosing of non-ambulatory patients is discontinued in...
Columvi is the first bispecific antibody to show a statistically significant and clinically meaningful 41% survival benefit in R/R DLBCL in the phase III STARGLO study1,2 There is an urgent need for effective, immediately available therapies that are broadly accessible to people with transplant-ineligible R/R DLBCL This first-of-its-kind Columvi combination could...
Basel – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the decision to discontinue dosing in the Phase III GENERATION HD1 study of tominersen in manifest Huntington’s disease (HD). The decision was based on the results of a pre-planned review of the data from the Phase III study conducted by...
Basel – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. MMR is a molecular mechanism that functions to correct certain errors that can spontaneously occur during DNA replication. Testing can...
Basel, Switzerland – After a lackluster data leak in 2023, Roche’s Genentech is turning the tables with positive Phase III data for its anti-TIGIT immunotherapy. The subsidiary revealed study results Tuesday in an abstract at this week’s American Society of Clinical Oncology Gastrointestinal Cancers Symposium. In patients with esophageal squamous...