Roche named among top three most sustainable healthcare companies in the Dow Jones Sustainability Indices
The ranking acknowledges Roche ’s commitment to sustainability as an integral part of its business strategyRoche performed particularly well in innovation management, access to healthcare, greenhouse gas emissions, water management, resource efficiency and circularity, labour practice indicators and human rightsThis marks the 15th consecutive year that Roche has maintained its leading rankingBasel, 15 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) has again been recognised as one of the most sustainable companies in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI). Roche ranked third, Chugai P...
Source: Roche Media News - December 15, 2023 Category: Pharmaceuticals Source Type: news
New data for Roche ’s Columvi and Lunsumio presented at ASH 2023 support continued benefit for people with lymphoma
Longer-term data from pivotal studies of fixed-duration Columvi and Lunsumio continue to show durable responses in people with heavily pre-treated lymphomas1,2New data reinforce the potential of combination regimens in earlier treatment settings and add to the robust body of evidence supporting ongoing Phase III studies3,4,5,6Basel, 11 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data from its CD20xCD3 T-cell engaging bispecific antibody programme, including eight oral presentations, were presented at the 65th American Society of Hematology (ASH) Annual Meeting& Exposition, 9-12 December ...
Source: Roche Media News - December 11, 2023 Category: Pharmaceuticals Source Type: news
New data reinforce the benefit of early preventative treatment with Roche ’s Hemlibra for babies with severe haemophilia A
Phase III HAVEN 7 primary data presented at ASH 2023 provide additional confidence in the favourable efficacy and safety profile of subcutaneous Hemlibra given soon after birth1At nearly two years median follow-up in the descriptive, single-arm study, no babies experienced spontaneous bleeds requiring treatment, and all treated bleeds were as a result of trauma1Safety results were consistent with previous studies of Hemlibra, with no new safety signals observed1The HAVEN 7 study was developed in collaboration with the haemophilia A community, to generate additional evidence for the prophylactic treatment of infants with ha...
Source: Roche Media News - December 9, 2023 Category: Pharmaceuticals Source Type: news
Roche's Kadcyla is the first targeted therapy to show significant overall survival benefit in people with HER2-positive early-stage breast cancer with residual invasive disease after neoadjuvant treatment
Phase III KATHERINE results reinforce Kadcyla as the standard of care for this population, with more than 82,000 people treated to date1,2Long-term data also showed continued benefit in invasive disease-free survival for adjuvant Kadcyla compared to Herceptin in this study2These data will be presented as an oral presentation at the 2023 San Antonio Breast Cancer Symposium and included in the official press programmeBasel, 8 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive long-term follow-up data from the pivotal, phase III KATHERINE study in people with HER2-positive early-stage breast cancer (e...
Source: Roche Media News - December 8, 2023 Category: Pharmaceuticals Source Type: news
Roche ’s inavolisib combination reduces the risk of disease progression by 57% in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation
Inavolisib in combination with palbociclib and fulvestrant more than doubled progression-free survival compared to palbociclib and fulvestrant alone1The inavolisib combination has the potential to address resistance to treatment and poor prognosis associated with PIK3CA mutations2-5These new data are being presented today in an oral presentation at the 2023 San Antonio Breast Cancer Symposium and shared with health authoritiesBasel, 8 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) presented today positive results from the Phase III INAVO120 study evaluating inavolisib in combination with palbociclib (Ibrance ®) and fu...
Source: Roche Media News - December 8, 2023 Category: Pharmaceuticals Source Type: news
Roche announces positive Phase III results for inavolisib combination in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation
Phase III (INAVO120) results show that inavolisib in combination with palbociclib and fulvestrant significantly improved progression-free survival in the first-line settingPIK3CA mutations, found in approximately 40% of HR-positive breast cancers, are linked to tumour growth, disease progression, and treatment resistance1,2Data will be shared with health authorities and presented at an upcoming medical meetingBasel, 5 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase III INAVO120 study of the investigational therapy, inavolisib, in combination with palbociclib (Ibrance ®) a...
Source: Roche Media News - December 5, 2023 Category: Pharmaceuticals Source Type: news
Roche enters into a definitive merger agreement to acquire Carmot Therapeutics, including three clinical stage assets with best-in-class potential in obesity and diabetes
Carmot Therapeutics ’s R&D portfolio of clinical stage incretins has great potential to treat obesity, diabetes and potentially other diseases both as standalone medicines and in combination with Roche ’s in-house assetsLead asset CT-388 is a Phase-2 ready dual GLP-1/GIP agonist with best-in-class potential for the treatment of obesity and its comorbiditiesUnder the terms of the agreement, Roche will pay a purchase price of USD 2.7 billion upfront and additional milestone payments of up to USD 400 millionBasel, 4 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the entry into a definitive merger a...
Source: Roche Media News - December 4, 2023 Category: Pharmaceuticals Source Type: news
Roche expands hepatitis diagnostics portfolio to help clinicians diagnose and monitor patients with acute or chronic hepatitis B infection
Elecsys ® HBeAg quant is an immunoassay that can be used as an early marker of acute hepatitis B infection, as well as an indicator of chronic active hepatitis in combination with other laboratory results and clinical information.The single test will inform clinicians if treatment is required and regimens are working in conjunction with other diagnostic assays.Almost 300 million people globally have chronic hepatitis B, causing a significant burden to health systems as it puts patients at high risk of death from cirrhosis and liver cancer.1Basel, 27 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the la...
Source: Roche Media News - November 27, 2023 Category: Pharmaceuticals Source Type: news
Roche launches automated serology hepatitis E virus tests, including a test to detect acute HEV infections, recommended in the new WHO 2023 Essential Diagnostics List
It is estimated that one third of the global population could be at risk for infection with Hepatitis E virus.1The new tests allow clinicians to diagnose acute and chronic infections amongst patients presenting with or without signs of the illness as recommended by the European Association for the Study of the Liver (EASL).2The tests complete Roche ’s panel used for the differential diagnosis of acute viral hepatitis caused by the hepatitis A, B, C and E viruses.Basel, 16 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the Elecsys ®Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for t...
Source: Roche Media News - November 16, 2023 Category: Pharmaceuticals Source Type: news
Roche ’s subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types
If approved, Tecentriq subcutaneous (SC) would be the first injectable PD-(L)1 cancer immunotherapy in the EU, cutting treatment time by approx. 80%1 The CHMP recommended Tecentriq SC for all indications of intravenous (IV) Tecentriq, including certain types of lung, liver, bladder and breast cancer2A majority of healthcare professionals surveyed in the IMscin001 study found that the SC formulation is easy to administer and could save time compared with IV1Basel, 14 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (C...
Source: Roche Media News - November 14, 2023 Category: Pharmaceuticals Source Type: news
Roche ’s Elecsys NfL test, an important aid for those living with Multiple Sclerosis, is granted FDA Breakthrough Device Designation
Roche Elecsys NfL aids in detection of disease activity in adults with Multiple Sclerosis supporting better disease management decisionsElecsys NfL offers a minimally invasive testing option that can provide rapid answers to patients and caregiversNfL has the potential to provide patient insights for other neurological conditions such as Alzheimer ’s and Huntington’s diseasesBasel, 9 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its Elecsys ® Neurofilament Light Chain (NfL) test for Multiple Sclerosis (MS) received Breakthrough Device Designation from the U.S. Food and Drug Administration (FD...
Source: Roche Media News - November 9, 2023 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche announces EMBARK trial in Duchenne muscular dystrophy (DMD) did not reach primary endpoint, but shows positive efficacy outcomes on all timed functional key endpoints
This study is ongoing.Study 301 (EMBARK), a Phase 3 global, randomised, double-blinded and placebo-controlled study of Elevidys in ambulatory Duchenne patients aged 4-<8 years old.The ENVOL trial (Study 302) a Phase 2 study in children with Duchenne. The study aims to enrol 21 participants who are under 4 years of age, including newborns. Not yet started.The ENVISION trial (Study 303), a Phase 3 study in older ambulatory/non-ambulatory patients which is now recruiting.The EXPEDITION long-term (5 year) follow up study (Study 305) of participants who have received Elevidys in a previous clinical study, which is not yet re...
Source: Roche Media News - October 31, 2023 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche ’s Vabysmo for the treatment of retinal vein occlusion (RVO)
RVO is the third indication for Vabysmo, in addition to neovascular or ‘wet’ age-related macular degeneration and diabetic macular edemaApproval is based on two phase III studies demonstrating early and sustained vision improvements that were non-inferior to afliberceptVabysmo also demonstrated rapid and robust drying of retinal fluidAdditional U.S. label update across indications includes information on rare post-marketing reports of retinal vasculitis and/or retinal vascular occlusion; reporting rate isin line withother broadly used intravitreal treatmentsBasel, 27 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) an...
Source: Roche Media News - October 27, 2023 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche enters into a definitive agreement to acquire Telavant including rights to novel TL1A directed antibody (RVT-3101) for the treatment of inflammatory bowel disease from Roivant
Roche will gain the rights to develop, manufacture and commercialise RVT-3101 in the US and Japan for the treatment of inflammatory bowel disease and potentially multiple other diseasesRVT-3101 is a Phase 3-ready antibody with first-in-class and best-in-disease potential, a novel mode of action and strong Phase 2b data in ulcerative colitisRoche will also obtain an option to enter into a global collaboration with Pfizer on a next-generation p40/TL1A directed bispecific antibody, currently in Phase 1Under the terms of the agreement, Roche will pay a purchase price of US$ 7.1 billion upfront and a near-term milestone payment...
Source: Roche Media News - October 23, 2023 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good sales growth despite decline in demand for COVID-19 products
Basel, 19 October 2023Groupsales grow by 1%1at constant exchange rates (CER) in the first nine months, showing a strong increase of 7% in the third quarterExcluding COVID-19 products,Group salesincrease by 9%Pharmaceuticals Division sales grow by 9%, driven by continued high demand for newer medicinesDiagnostics Division ’s base businessincreases by 7%;overall divisional sales are down 18% due to a surge in demand for COVID-19 tests in 2022Highlightsin the third quarter of 2023:EU approval ofEvrysdifor babies under two months old with spinal muscular atrophyFirst approval of subcutaneous form of cancer immunotherapyTecen...
Source: Roche Media News - October 19, 2023 Category: Pharmaceuticals Source Type: news
