March 13, 2020 Acad, Gov/Utilities PR/Corporate

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

March 12, 2020 PAI Top-10

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

March 11, 2020 Acad, Gov/Utilities Bio/Pharma/CRO PR/Corporate

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

March 4, 2020 Acad, Gov/Utilities Atomic Spectroscopy

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

February 25, 2020 Acad, Gov/Utilities

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

February 19, 2020 Acad, Gov/Utilities

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

February 14, 2020 Uncategorized

China National Medical Products Administration grants approval of Roche’s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung cancer

This marks the first approval for a Tecentriq-based therapy in China, less than a year after the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals in this indication Tecentriq with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy combination approved for the initial treatment of extensive-stage small cell... Read more

February 10, 2020 Bio/Pharma/CRO

Roche provides topline results from investigator-led Phase II/III trial with gantenerumab in rare inherited form of Alzheimer’s disease

Primary endpoint was not met in a study sponsored by Washington University; additional analyses are ongoing to understand the totality of the data Data from study in people with or at-risk for autosomal dominant Alzheimer’s disease will be presented at the AAT-AD/PD Focus meeting in April 2020 Results do not impact Roche’s two ongoing Phase... Read more

February 6, 2020 Licensing, IP, and Legal

Roche’s risdiplam showed significant improvement in motor function in people aged 2-25 with type 2 or 3 spinal muscular atrophy

First placebo-controlled trial to include adults with SMA demonstrates risdiplam improved or stabilised motor function  Medically meaningful and statistically significant results in primary and key secondary endpoints Pivotal SUNFISH Part 2 study population represents broad, real-world spectrum of people living with SMA Basel, 06 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented... Read more

January 30, 2020 Uncategorized

Roche reports very strong results in 2019

Basel, 30 January 2020 Group sales increase 9%1 at constant exchange rates and 8% in Swiss francs, driven by new products, more than compensating for impact of competition from biosimilars Pharmaceuticals Division sales up 11%, resulting from high demand for recently launched medicines, led by Ocrevus, Hemlibra, Tecentriq and Perjeta Diagnostics Division sales grow by... Read more