March 11, 2021 Clinical Research/Diagn. Microscopy PR/Corporate

Roche’s awarded WHO prequalification for the HIV and HCV diagnostic tests on the cobas 6800/8800 Systems

For patients living in areas with limited healthcare resources, WHO prequalification ensures access to the highest quality diagnostics Access to broader reliable diagnostic solutions helps healthcare communities working to expedite and increase disease elimination programs Roche’s Global Access Program provides innovative diagnostic solutions improving disease and patient management for those most in need Basel, 11... Read more

March 11, 2021 Bio/Pharma/CRO Microscopy

Roche provides update on the phase III REMDACTA trial of Actemra/RoActemra plus Veklury in patients with severe COVID-19 pneumonia

The REMDACTA clinical trial of Actemra/RoActemra plus Veklury did not meet its primary endpoint of improved time to hospital discharge for patients with severe COVID-19 pneumonia or its key secondary endpoints compared to Veklury alone Roche will submit the REMDACTA results to a peer-reviewed journal Basel, 11 March 2021 – Roche (SIX: RO, ROG; OTCQX:... Read more

March 8, 2021 Uncategorized

Roche provides update on Tecentriq US indication in prior-platinum treated metastatic bladder cancer

Basel, 8 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the company is voluntarily withdrawing the US indication for Tecentriq® (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer). This decision was made in consultation with the US Food and Drug Administration (FDA) as part of an industry-wide review of... Read more

March 5, 2021 Acad, Gov/Utilities Microscopy

Roche’s Actemra/RoActemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease, a rare, debilitating condition

Systemic sclerosis (SSc) is a rare disease that affects about 2.5 million people worldwide Approximately 80% of SSc patients may be affected by interstitial lung disease (ILD), a progressive disease that can significantly impact lung function and can be life-threatening In a global study, Actemra/RoActemra reduced the rate of progressive loss of lung function in... Read more

February 26, 2021 PR/Corporate

Roche SARS-CoV-2 Rapid Antigen Test receives special approval for at-home patient self-testing using nasal swabs in Germany

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

February 26, 2021 Acad, Gov/Utilities

EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19

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

February 26, 2021 PR/Corporate

Roche receives positive CHMP opinion for Evrysdi, the first and only at home spinal muscular atrophy (SMA) treatment with proven efficacy in adults, children and infants two months and older

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

February 25, 2021 Licensing, IP, and Legal Product Launch

Roche announces results from Evrysdi (risdiplam) study in infants with Type 1 spinal muscular atrophy (SMA) published in New England Journal of Medicine

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

February 12, 2021 Bio/Pharma/CRO Product Launch

New phase III data show Roche’s faricimab is the first investigational injectable eye medicine to extend time between treatments up to four months in two leading causes of vision loss, potentially reducing treatment burden for patients

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

February 8, 2021 Acad, Gov/Utilities

FDA grants Breakthrough Device Designation for Roche's Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients

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