Basel, 13 October 2020 The Elecsys® SARS-CoV-2 Antigen test is an automated laboratory assay intended as an aid in the diagnosis of SARS-CoV-2 infection This new solution will run on all Roche cobas e immunochemistry analysers which are widely available around the world, thus helping to increase testing capacity In combination with other COVID-19 diagnostic... Read more
Exploratory efficacy data showed 88% of infants treated with Evrysdi were alive and did not require permanent ventilation at two years 59% of infants were able to sit without support for at least 5 seconds No new safety signals were identified In August, the FDA approved Evrysdi for the treatment of SMA in adults and... Read more
Data from the Phase III IMpassion031 study demonstrated that Tecentriq in combination with chemotherapy improved pathological complete response for patients with early triple-negative breast cancer (TNBC), when compared to placebo plus chemotherapy Final overall survival data from the Phase III IMpassion130 study were consistent with prior interim analyses in patients with metastatic TNBC, whose tumours... Read more
Recommendation is based on the results of the IMbrave150 study, in which the Tecentriq combination improved overall survival and progression-free survival compared with the previous standard of care Basel, 18 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)... Read more
The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. This is the focus of vaccines in development and convalescent plasma therapy.1 Using the Elecsys Anti-SARS-COV-2 S antibody test, together with the Elecsys... Read more
EMPACTA is the first global phase III trial to show efficacy with Actemra/RoActemra in COVID-19 associated pneumonia and the first with a focus on enrolling largely underserved and minority patients There was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo Roche plans to share these results with health authorities, including the... Read more
New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers New integrated analyses from our tumour agnostic Rozlytrek® (entrectinib) clinical development programme Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating GavretoTM(pralsetinib) for the treatment of people with RET-mutant medullary... Read more
Next-generation biomarker cytology test supports World Health Organization’s goal to eliminate cervical cancer, which is nearly 100 percent preventable with proper screening, vaccination and treatment New indication allows this first FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs More... Read more
75% of patients with relapsing-remitting multiple sclerosis (RRMS) and suboptimal response to prior treatment had no evidence of disease activity two years after switching to OCREVUS in open-label Phase IIIb CASTING study 97% persistence and strong adherence to OCREVUS treatment and twice-yearly dosing schedule from real-world data OCREVUS is the first and only treatment approved... Read more
ENSPRYNG lowered relapse severity in double-blind periods of SAkura Phase III studies. Pooled data from SAkura open-label extension (OLE) studies support continued effect of ENSPRYNG reducing risk of relapse in the longer term Ongoing data continues to show a favourable safety profile for ENSPRYNG ENSPRYNG was recently approved by the U.S. Food and Drug Administration... Read more