Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s disease (AD). This designation is based on data showing that gantenerumab significantly reduced brain amyloid plaque, […]

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Phase II/III trial shows Ronapreve™ (casirivimab and imdevimab) significantly reduces viral load in patients hospitalised with COVID-19

Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive data from the phase II/III 2066 study, investigating Ronapreve™ (casirivimab and imdevimab) in patients hospitalised with COVID-19. The trial met its primary endpoint, showing that Ronapreve significantly reduced viral load within seven days of treatment in patients who had not mounted a natural antibody response of […]

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Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve™ (casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. “Ronapreve […]

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Roche’s Actemra/RoActemra receives U.S. FDA Emergency Use Authorization for the treatment of COVID-19 in hospitalised adults and children

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra/RoActemra® (tocilizumab) for the treatment of COVID-19 in hospitalised adults and paediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or […]

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European Commission approves Venclyxto-based combinations for adults with newly diagnosed acute myeloid leukaemia

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Venclyxto® (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. “This Venclyxto approval is a critical step in providing new therapeutic options […]

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Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81%

Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive results from the phase III REGN-COV 2069 trial assessing the ability of the investigational antibody cocktail casirivimab and imdevimab to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals. The trial, which was jointly run with the National Institute of […]

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New phase III data shows investigational antibody cocktail casirivimab and imdevimab reduced hospitalisation or death by 70% in non-hospitalised patients with COVID-19

Roche (SIX: RO, ROG; OTCQX: RHHBY) confirmed positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalised patients (n=4,567; REGN-COV 2067). The phase III outcomes trial in high-risk non-hospitalised patients with COVID-19 met its primary endpoint, showing the investigational antibody cocktail of casirivimab and imdevimab significantly reduced the risk […]

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Roche confirms US government agreement to purchase additional doses of Regeneron’s casirivimab and imdevimab

Roche (SIX: RO, ROG; OTCQX: RHHBY) confirmed that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of Regeneron’s casirivimab and imdevimab antibody cocktail for use in non-hospitalised COVID-19 patients as part of Operation Warp Speed. The US government said it will provide these additional […]

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