Roche’s COVID-19 antibody test receives FDA Emergency Use Authorization and is available in markets accepting the CE mark

The serology test has a specificity greater than 99.8% and sensitivity of 100% (14 Days post-PCR confirmation) The high specificity of the test is crucial to determine reliably if a person has been exposed to the virus and if the patient has developed antibodies Roche will provide high double-digit millions of tests already in May... Read more

New 6-year data for Roche’s OCREVUS (ocrelizumab) show earlier treatment initiation nearly halves risk of needing walking aid in relapsing multiple sclerosis

Post-hoc analysis from 6 years of Phase III open-label extension studies showed OCREVUS treatment reduced the risk of needing a walking aid (EDSS≥6) by 49% in relapsing multiple sclerosis (RMS) patients compared with patients who switched from interferon beta-1a two years later Separate analysis showed OCREVUS slowed thalamic volume loss in patients with RMS and... Read more

Roche’s risdiplam shows significant improvement in survival and motor milestones in infants with Type 1 spinal muscular atrophy (SMA)

FIREFISH Part 2 study met its primary endpoint by demonstrating a significant increase in motor milestones in infants aged 1-7 months after 12 months of treatment Large, pivotal global study confirms clinically meaningful efficacy seen in the dose-finding Part 1 of the trial Safety was consistent with the safety profile observed to date and no... Read more

First quarter with 2% growth in Swiss francs, 7% at constant exchange rates

Basel, 22 April 2020 Group sales increase 2% in Swiss francs and 7%1 at constant exchange rates, driven by new products, more than compensating for impact of competition from biosimilars Pharmaceuticals Division sales up 7%, led by Tecentriq, Hemlibra, Ocrevus and Perjeta Diagnostics Division sales grow 5%, with molecular testing as main contributor Important approvals... Read more

Roche receives FDA approval for cobas HPV test for use on the cobas 6800/8800 Systems to identify women at risk for cervical cancer

More than 99 percent of cervical cancers are caused by persistent high-risk HPV infection1 Cervical cancer is nearly 100 percent preventable with proper HPV vaccination, screening and treatment; expanding access helps reach more women2,3 cobas 6800/8800 Systems deliver full automation, helping laboratories meet the throughput and efficiencies that high-volume, HPV DNA screening programs require              Basel,... Read more

US FDA and EMA accept applications for Roche’s OCREVUS (ocrelizumab) shorter 2-hour infusion time

Reduces infusion time to 2 hours from the current 3.5 hours for patients with relapsing or primary progressive multiple sclerosis, if approved Applications are based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the currently approved OCREVUS dosing regimen              Basel, 20 April 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY)... Read more

Roche develops new serology test to detect COVID-19 antibodies

The new Elecsys Anti-SARS-CoV-2 serology test can support the detection of antibodies against SARS-CoV-2 in patients who have been exposed to the virus which causes COVID-19 The detection of these antibodies could help indicate if a person has gained immunity against the virus and inform treatment decisions Roche aims to have this test available by... Read more

Roche provides regulatory update on risdiplam for the treatment of spinal muscular atrophy (SMA)

U.S. Food and Drug Administration (FDA) extends review time for risdiplam following agreed submission of additional data, including SUNFISH Part 2 Roche has submitted filing applications for risdiplam in seven countries with submission in China imminent Risdiplam is being investigated in infants, children and adults with Type 1, 2 or 3 SMA Basel, 07 April... Read more

Roche response to COVID-19 pandemic

Roche response to COVID-19 pandemic Roche accelerates delivery and production of Actemra Roche is working around the clock to increase availability of COVID 19-tests Roche calls on governments across the world to work closely with industry to keep manufacturing and supply running Basel, 24 March 2020 – Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today... Read more

Roche announces Venclexta/Venclyxto combination improved overall survival in people with previously untreated acute myeloid leukaemia

Phase III VIALE-A study showed Venclexta/Venclyxto plus azacitidine helped people with the most common type of aggressive leukaemia in adults live longer compared to azacitidine alone Data will be shared with global health authorities and presented at an upcoming medical meeting  Basel, 23 March 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that... Read more