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

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

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

Roche provides an update on the phase III COVACTA trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 associated pneumonia

COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality The study is the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in... Read more

Thermo Fisher Scientific and Lyell Immunopharma Form Cell Therapy Manufacturing Partnership

Thermo Fisher Scientific and Lyell Immunopharma Form Cell Therapy Manufacturing Partnership Collaboration will include development of Thermo Fisher products and strategic manufacturing support WALTHAM, Mass., July 28, 2020 /PRNewswire/ — Thermo Fisher Scientific Inc., the world leader in serving science, and biotechnology company Lyell Immunopharma, are partnering to develop manufacturing processes designed to create more... Read more

Phase III data show Roche’s Port Delivery System with ranibizumab enabled over 98% of patients to go six months between treatments for neovascular age-related macular degeneration

In the Archway study, Port Delivery System with ranibizumab (PDS) demonstrated non-inferior and equivalent visual acuity outcomes compared with monthly ranibizumab eye injections, and a favourable benefit-risk profile PDS is a permanent refillable eye implant that continuously delivers a customised formulation of ranibizumab over a period of months, potentially reducing the treatment burden associated with... Read more

New data from phase IIIb study reinforces safety profile of Roche’s Hemlibra in people with haemophilia A

Basel, 13 July 2020 Second interim analysis of the STASEY study, including data from 193 patients, consistent with results from phase III HAVEN studies, with no new safety signals identified1,2,3 STASEY is the largest open-label study primarily assessing safety and tolerability of a medicine for haemophilia A with factor VIII inhibitors A separate analysis also... Read more

Roche provides update on Phase III study of Tecentriq in women with advanced stage ovarian cancer

Basel, 13 July 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMagyn050 study showed that the addition of Tecentriq® (atezolizumab) to Avastin® (bevacizumab), paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival (PFS) for the front-line treatment of women with newly diagnosed advanced stage ovarian cancer.... Read more