Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia

Basel, 19 March 2020- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced  we are working with the Food & Drug Administration (FDA) to initiate a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Health and Human Services Office of the... Read more

Roche Annual General Meeting 2020

Basel, 17 March 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its shareholders approved all proposals of the Board of Directors at its ordinary Annual General Meeting (AGM). On the basis of COVID-19 Ordinance 2 of the Swiss Federal Council, no shareholders were admitted to attend the General Meeting in person. Roche... Read more

Roche Annual General Meeting 2020: Voting will take place by independent proxy. Participation on site is neither possible nor permitted by Federal Council ordinance

The Roche Annual General Meeting 2020 will be held under conditions of the COVID-19 Ordinance 2 of the Federal Council To comply with regulatory requirements, voting at the AGM will be by independent proxy Shareholders who are physically present will be able to cast their votes through the proxy, but will not be admitted to... Read more

Roche Annual General Meeting 2020 to take place under special conditions set by the authorities – electronic voting strongly recommended

Annual General Meeting on 17 March 2020 will take place as planned under conditions set by the authorities in Switzerland Roche strongly advises against physical participation and recommends electronic voting via the independent proxy Despite health measures participation will be at attendees’ own risk Basel, 14 March 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY)... Read more

Roche’s cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use Authorization and is available in markets accepting the CE mark

First commercial test for SARS-CoV-2 will enable expedited coronavirus testing to meet urgent medical needs Testing on widely available, high-volume cobas 6800/8800 will significantly increase available testing capacity Roche expedites test development to support urgent need for patient testing during pandemic outbreak to avoid a further spread of the virus at an early stage of... Read more

European Commission approves Venclyxto plus Gazyvaro for adults with previously untreated chronic lymphocytic leukaemia

Combination regimen offers a new 12-month, fixed-duration, chemotherapy-free treatment option for adult patients with chronic lymphocytic leukaemia Results of the phase III CLL14 study add to the growing body of evidence supporting the potential of Venclyxto-based combinations across multiple lines Data showed that a fixed duration of treatment with Venclyxto plus Gazyvaro reduced the risk... Read more

Roche receives FDA approval for CINtec PLUS Cytology test to aid clinicians in improving cervical cancer prevention

Next-generation cytology test provides additional information for HPV-positive women who may have cervical pre-cancer More sensitive than Pap cytology testing when used as triage test for HPV-positive screening results, helping to improve the detection of cervical pre-cancer The first biomarker-based test specifically approved by the FDA to triage women with HPV-positive / Pap cytology-negative co-testing... Read more

FDA grants Breakthrough Device Designation for Roche's Elecsys GALAD score to support earlier diagnosis of hepatocellular carcinoma

The Elecsys GALAD score aims to support clinicians in diagnosing hepatocellular carcinoma by giving them more timely and accurate information to make earlier interventions When hepatocellular carcinoma is detected and managed at the very earliest, patient’s 5-year survival rates can increase to over 70%1 Utilizing blood-based biomarkers, as part of the Elecsys GALAD score, is... Read more

FDA accepts Roche’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer

Fixed-dose combination administered under the skin in just minutes, compared to hours with intravenous administration, significantly reducing time spent receiving treatment US Food Drug and Administration is expected to decide on approval by 18 October 2020 Basel, 25 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug... Read more

FDA grants priority review to Roche’s Tecentriq monotherapy as first-line treatment of certain people with advanced non-small cell lung cancer

Basel, 19 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without... Read more