Special approval from German Federal Institute for Drugs and Medical Devices (BfArM) enables home use of a SARS-CoV-2 Rapid Antigen Test using a simple nasal swab The test will be widely available in pharmacies across Germany Basel, 26 February 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has been granted special approval... Read more
CHMP has completed a review of available data for investigational antibody cocktail casirivimab and imdevimab (REGN-COV2) to be considered for the treatment of confirmed COVID-19 CHMP scientific opinion supports national decision making within EU states on the use of the antibodies before a formal authorisation is granted during a public health emergency Roche and... Read more
In two pivotal clinical studies, Evrysdi showed event-free survival and motor milestone improvements never previously achieved in the natural history of the disease More than 2,500 patients now treated with Evrysdi in clinical trial, compassionate use and real-world settings Evrysdi is approved in seven countries, submitted in 30 more Basel, 26 February 2021 – Roche... Read more
FIREFISH Part 1 data show treatment with Evrysdi at 12 months helped 90% of these infants survive without permanent ventilation and 33% sit without support, a key motor milestone not normally seen in the natural course of the disease The FDA approved Evrysdi in August 2020 as the first and only at home SMA treatment... Read more
Across four studies in diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD), approximately half of people receiving faricimab could be treated every four months in the first year Approximately three-quarters of people receiving faricimab could be treated every three months or longer in the first year Faricimab showed rapid and consistent improvements in... Read more
FDA BDD acknowledges the importance of GDF-15 testing in identifying eligible cachexic patients with solid tumours to be treated with Pfizer’s investigational drug PF-06946860 Unintentional weight loss (cachexia) is a highly prevalent complication of cancer, affecting more than half of all cancer patients worldwide, potentially leading to significant functional impairment and increased risk of death... Read more
Basel, 04 February 2021 Group sales increase 1%1 at constant exchange rates (CER); 5% decline in Swiss francs, as a result of continued appreciation of the Swiss franc against most currencies Pharmaceuticals Division sales decline 2%; continued strong sales growth of newly launched medicines (+32%2, including Tecentriq, Hemlibra, Ocrevus, Perjeta and Kadcyla) largely offsets the... Read more
Basel, 01 February 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has obtained the CE mark for its new SARS-CoV-2 Rapid Antigen Test Nasal. The test will be available in countries accepting the CE mark by mid-February 2021. In comparison to the existing Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen... Read more
This successful long-running partnership continues to evolve and bring haematology testing innovations to laboratories, globally The new agreement aims to utilise the IT systems to lead to improved clinical decision making and customer experience Blood disorders have a high impact, not only for patients but for society as a whole, accounting for a third of... Read more
Faricimab given at intervals of up to every 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks, potentially reducing the frequency of injections and overall burden of treatment Nearly half of people were treated with faricimab every 16 weeks during the first year – the first time this level of... Read more