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
Nearly 2.1 million new cases of breast cancer are diagnosed worldwide each year, and more than 620,000 people will die from the disease.1 About 15 to 20 percent of women diagnosed with breast cancer are HER2 positive.2 VENTANA HER2 Dual ISH DNA Probe Cocktail assay3 aids in identifying HER2-positive breast cancer patients eligible for the... Read more
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
Basel, 23 July 2020 Group sales increase 1%1 at constant exchange rates and decline 4% in Swiss francs as a result of continued appreciation of the Swiss franc against most currencies COVID-19 pandemic has a negative impact on sales during the second quarter; since June sales are recovering Pharmaceuticals Division sales up 1%, driven by... Read more
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
Roche will obtain co-development and co-commercialisation rights for pralsetinib, an investigational, precision therapy in late-stage development for people with RET-altered non-small cell lung cancer, various types of thyroid cancer and other solid tumours. Blueprint Medicines and Roche will collaborate on the development of pralsetinib. Roche and Blueprint Medicines will co-commercialise pralsetinib in the US while... Read more
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
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
Basel, 29 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Phesgo™, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and... Read more
Spark Therapeutics will present data from the initial dose cohorts of its phase I/II SPK-8011 gene therapy study, showing stable and durable factor VIII expression, substantial improvement in annualised bleed rate for more than two years, and an acceptable safety profile after more than two years of follow-up1 Roche will present second interim analysis results... Read more