STRONG-HF study results demonstrate clear benefits for acute heart failure patients
STRONG-HF study primary outcomes showed significant reduction of all cause death or acute heart failure readmissions, at day 180, when the study strategy was implementedRapid, simultaneous up-titration of therapies, and close follow-up, led to increased patient quality of life.The RocheElecsys® NT-proBNP biomarker is an integral part of the treatment strategy, comprising rapid up-titration and close follow up after an acute heart failure admissionBasel, 9 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced publication of the Safety, Tolerability and Efficacy of Rapid Optimization of Heart Failure (STRONG-HF...
Source: Roche Media News - November 9, 2022 Category: Pharmaceuticals Source Type: news
Roche to present data at ASH 2022 showcasing strength of haematology portfolio and expanding into new areas to address more patient needs
Interim data from phase III HAVEN 7 study reinforceHemlibra ’s efficacy and safety in infants with severehaemophilia A without factor VIII inhibitors1New and updated data support use ofPolivy in diffuse large B-cell lymphoma, including its potential as a treatment option for previously untreated patients2New and updated data for innovative CD20xCD3 T-cell engaging bispecific antibodiesLunsumio andglofitamab further enhance their potential as effective, off-the-shelf, fixed-duration treatment options for people with lymphoma3,4,5,6,7First phase III data forcrovalimab show the co-primary efficacy endpoints were met, with s...
Source: Roche Media News - November 3, 2022 Category: Pharmaceuticals Source Type: news
Positive topline phase III results show Roche's Vabysmo improved vision for people living with retinal vein occlusion (RVO)
Vabysmo achieved its primary endpoint of non-inferiority toaflibercept in RVO in the BALATON and COMINO clinical trialsVabysmo was generally well tolerated, with a safety profile consistent with previous trialsVabysmo is the first and only treatment that targets and inhibits two disease pathways involving Ang-2 and VEGF-A, linked to a number of vision-threatening retinal conditionsDetailed results will be presented at an upcoming medical meeting and submitted to regulatory authorities around the worldBasel, 27 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two global phase I...
Source: Roche Media News - October 27, 2022 Category: Pharmaceuticals Source Type: news
Early treatment with Roche's OCREVUS leads to reduced disease progression and healthcare costs; nine-year safety data reinforce favourable benefit-risk profile
77% of early-stage relapsing-remitting multiple sclerosis (RRMS) patients who had not received prior treatment achieved no evidence of disease activity (NEDA) at two yearsInitiation of OCREVUS as first-line treatment reduces relapses,hospitalisations and costs compared with using OCREVUS in second-line settingNine-year long-term safety data for OCREVUS further reinforcefavourable benefit-risk profile; more than 250,000 people have been treated globallyPregnancy outcomes reported for more than 2,000 women with multiple sclerosis (MS) treated with OCREVUS do not suggest an increased risk of adverse pregnancy and infant outco...
Source: Roche Media News - October 26, 2022 Category: Pharmaceuticals Source Type: news
Roche receives FDA clearance for COVID-19 PCR test for use on cobas 6800/8800 Systems
Thecobas SARS-CoV-2 Qualitative test is one of the first COVID-19PCR tests performed on an automated, high throughput platform to receive FDA 510(k) clearance.This FDA clearance will ensure that the healthcare community has access to timely, reliable and accurate COVID-19 PCR testing beyond the EUA period.Based on continuous analysis performed since the onset of the pandemic, all Roche molecular tests, including thecobas SARS-CoV-2 Qualitative test, detect all SARS-CoV-2 variants.Basel, 24 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) c...
Source: Roche Media News - October 24, 2022 Category: Pharmaceuticals Source Type: news
Roche to present new OCREVUS (ocrelizumab) data in multiple sclerosis and continued research into neuromyelitis optica spectrum disorder at ECTRIMS 2022
OCREVUS data will show significant benefit on slowing disease activity and progression in patients with treatment-naive early-stage relapsing-remitting multiple sclerosis (RRMS)Largest pregnancy safety data across anti-CD20 medicines for OCREVUS in multiple sclerosis (MS)Nine-year safety data for OCREVUS reinforces itsfavourable benefit-risk profileNew research demonstrates impact of misdiagnosis and delay of starting treatment in NMOSDBasel, 19 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new OCREVUS ® (ocrelizumab) data and continued research into neuromyelitis optica spectrum disorder (NMOSD) ...
Source: Roche Media News - October 19, 2022 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche records solid results for the first nine months of 2022
Basel, 18 October 2022Group salesup 2%1 at constant exchange rates (CER) and 1% in Swiss francs; as expected, significantly lower COVID-19-related sales in both divisions in the third quarterSales in the Pharmaceuticals Divisionat the previous year ’s level with significantly lower sales of COVID-19-related products (Ronapreve and Actemra/RoActemra) and losses to biosimilars, offset by strong growth of newer medicinesSales in the Diagnostics Divisionrise 6%; base business remains strong; as expected, demand for COVID-19 tests sharply down in third quarterHighlights in the third quarter:EU approval forVabysmo (severe eye ...
Source: Roche Media News - October 18, 2022 Category: Pharmaceuticals Source Type: news
Roche to introduce its next-generation portfolio of SARS-CoV-2 rapid antigen tests ( “2.0”) under CE Mark for self-test and professional use
Broad and trusted portfolio of COVID-19 rapid tests feature innovative updates and enhanced performance, building on insights gained throughout the pandemicAll tests now work seamlessly with navify ® Pass, Roche’s digital solution that allows individuals and healthcare professionals to immediately store, display, and share COVID-19 vaccination status and test results through a unique data matrixRoche maintains the capacity to provide tens of millions tests each month to meet sustained high worldwide demand from individuals and healthcare professionals Basel, 12 October 2022- Roche (SIX: RO, ROG; OTCQX: RHHBY) today...
Source: Roche Media News - October 12, 2022 Category: Pharmaceuticals Source Type: news
Positive new data for Roche ’s Evrysdi in largest trial ever undertaken in patients with previously-treated spinal muscular atrophy (SMA)
New two-year Evrysdi data show improvement or maintenance of motor function in people with SMA, a progressive neuromuscular disease that can be fatalThe JEWELFISH study enrolled the broadest and most diverse patient population ever studied in an SMA trialLonger-term safety data consistent with that previously seen in earlier trials and low study drop-out rateEvrysdi has proven efficacy in babies, children and adults, with more than 7,000 patients treated to date worldwideBasel, 12 October 2022- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new two-year data from the JEWELFISH study evaluating Evrysdi ® (risdiplam) in...
Source: Roche Media News - October 12, 2022 Category: Pharmaceuticals Source Type: news
Roche launches PRAME (EPR20330) Antibody to identify PRAME protein expression in patients that may have melanoma
The PRAME (EPR20330) Antibody evaluates PRAME protein expression from patients with suspected melanoma.Understanding if the PRAME protein is expressed helps enable more informed clinical decisions and may improve patient outcomes.The PRAME (EPR20330) Antibody is the latest addition to Roche ’s robust dermatology portfolio with more than 50 dermatology biomarkers designed to meet a broad range of diagnostic needs.Basel, 11 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of Anti-PRAME (EPR 20330) Rabbit Monoclonal Primary Antibody to identify PRAME protein expression in tissue samples from pati...
Source: Roche Media News - October 11, 2022 Category: Pharmaceuticals Source Type: news
Roche to present new data from its expanding neuromuscular disease portfolio at World Muscle Society 2022
New positive data fromEvrysdi, a treatment for spinal muscular atrophy (SMA), a progressive neuromuscular disease that can be fatalData from the gene therapyprogramme forDuchenne muscular dystrophy (DMD), a progressive disease that leads to premature death, reinforce confidence in the most advanced Phase 3 study currently underwayStudy designs of two new trials ingeneralised myasthenia gravis (gMG), a rare chronic autoimmune disease, andfacioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorderBasel, 05 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its industry-leading n...
Source: Roche Media News - October 5, 2022 Category: Pharmaceuticals Source Type: news
Roche receives FDA approval for first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for ENHERTU
Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2. These patients with HER2 low status may now be eligible for a targeted treatment, which could significantly improve their outcomes.1,2The PATHWAY anti-HER2 (4B5) test is the only FDA approved companion diagnostic indicated as an aid in the assessment of HER2 low status in metastatic breast cancer patients. These patients may now consider ENHERTU as a treatment option based on the results of the Phase 3 DESTINY-Breast04 trial.3Basel, 4 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug ...
Source: Roche Media News - October 4, 2022 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche: Change in the Corporate Executive Committee in January 2023
Basel, 3 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Matt Sause (45), currently Head of Roche Diagnostics ’ North America Region, will become CEO Roche Diagnostics and a member of the Corporate Executive Committee effective 1 January 2023.Thomas Schinecker, the incumbent CEO of the Diagnostics Division and new Roche CEO as of 15 March 2023: “Matt Sause’s career at Roche has spanned twenty years in multiple countries across Asia, Latin America, Europe and North America in both the Diagnostics and Pharma divisions. His combination of scientific knowledge with commercial experience makes him a...
Source: Roche Media News - October 3, 2022 Category: Pharmaceuticals Source Type: news
Change in the Roche Board of Directors
Basel, 26 September 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Julie Brown has notified the Board that she will step down as a member of the Roche Board of Directors as she has accepted a management role at another pharmaceutical company. This change will be effective from today.Ms. Brown was elected to the Board of Directors in March 2016 and has since been the Chairwoman of the Audit Committee. Dr. Patrick Frost will chair the Audit Committee on an interim basis until the Annual General Meeting in March 2023.Roche Chairman Christoph Franz: " As a Board member and Chairwoman of the Audit Committee, Jul...
Source: Roche Media News - September 26, 2022 Category: Pharmaceuticals Source Type: news
European Commission approves Roche ’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
Phase III data that showed people with nAMD and DME treated with Vabysmo up to every four months achieved similar outcomes compared to receiving treatment every two months with afliberceptIn addition, patients treated with Vabysmo received up to 33% fewer median number of injections compared to afliberceptReducing the number of eye injections over time could offer a less burdensome treatment schedule for individuals, their caregivers and healthcare systemsVabysmo simultaneously targets and inhibits two disease pathways involving Ang-2 and VEGF-A linked to a number of vision-threatening retinal conditionsBasel, 19 September...
Source: Roche Media News - September 19, 2022 Category: Pharmaceuticals Source Type: news
