September 1, 2020 Acad, Gov/Utilities Bio/Pharma/CRO Microscopy PR/Corporate

Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS

Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management of patients with HIV – from appropriate counseling on disease differences to targeted therapy Supports rapid molecular detection of acute HIV infection, which is critical in curbing further disease transmission Combines confirmatory HIV testing and HIV-1/HIV-2 differentiation into... Read more

August 28, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

Roche announces FDA approval of FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test

FoundationOne Liquid CDx analyses more than 300 cancer-related genes and multiple genomic signatures to help inform treatment decisions for all solid tumour cancers Using a simple blood draw, the test allows more patients with advanced cancer to benefit from the insights of comprehensive genomic profiling, for example when a tissue biopsy is not possible or... Read more

August 19, 2020 Uncategorized

Roche and Regeneron collaborate to significantly increase global supply of REGN-COV2 investigational antibody combination for COVID-19

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. The companies will collaborate on developing and manufacturing REGN-COV2. Regeneron will distribute REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S. Under this collaboration, the overall capacity of REGN-COV2 is expected to... Read more

August 10, 2020 Acad, Gov/Utilities Licensing, IP, and Legal

FDA approves Roche’s Evrysdi (risdiplam) for treatment of spinal muscular atrophy (SMA) in adults and children 2 months and older

Basel, 10 August 2020 In two clinical trials, Evrysdi improved motor function in people living with SMA over a broad spectrum of ages and levels of disease severity, including Types 1, 2, and 3 SMA Evrysdi helped infants survive without permanent ventilation and achieve the ability to sit without support, a key motor milestone not... Read more

August 10, 2020 Bio/Pharma/CRO Chromatography

Roche provides update on phase III studies of etrolizumab in people with moderately to severely active ulcerative colitis

Etrolizumab met its primary endpoint of inducing remission versus placebo for people with ulcerative colitis in only two of three studies Etrolizumab failed to meet its primary endpoint versus placebo as maintenance therapy in people with ulcerative colitis Analyses of these data are ongoing to better understand the results Pivotal phase III study of etrolizumab... Read more

August 6, 2020 Bio/Pharma/CRO Licensing, IP, and Legal

Roche provides update on Phase III study of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer

Basel, 06 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpassion131 study, evaluating Tecentriq® (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-free survival (PFS) for the initial (first-line) treatment of people with metastatic... Read more

August 5, 2020 Acad, Gov/Utilities Microscopy

Roche announces FDA authorisation for the first Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems to improve care for transplant patients

Basel, 5 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has authorised the cobas® EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. This authorisation gives healthcare professionals a key tool in monitoring... Read more

August 3, 2020 Uncategorized

Rozlytrek, Roche’s first tumour-agnostic therapy, approved in Europe for people with NTRK fusion-positive solid tumours and for people with ROS1-positive advanced non-small cell lung cancer

Rozlytrek has shown durable responses across multiple tumour types, including cancer that has spread to the brain This approval shows the value of combining genomic profiling with precision medicine to offer patients with rare and hard-to-treat cancers a personalised treatment option              Basel, 03 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that... Read more

July 31, 2020 Acad, Gov/Utilities

FDA approves Roche’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma

Basel, 31 July 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) plus Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients.  The safety profile observed in the Tecentriq combination was consistent with the known safety profiles... Read more