US FDA approves Roche ’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer
Basel, 15 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Tecentriq ® (atezolizumab) as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%, as determined by an FDA-approved test. (Source: Roche Investor Update)
Source: Roche Investor Update - October 15, 2021 Category: Pharmaceuticals Source Type: news
Roche announces PathAI collaboration for artificial intelligence-based digital pathology applications for improved patient care
Basel, 15 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has entered an agreement with PathAI, a global leader in artificial intelligence (AI)-powered technology for pathology. Under the development and distribution agreement, the companies will jointly develop an embedded image analysis workflow for pathologists. This workflow will allow PathAI image analysis algorithms to be accessed within NAVIFY Digital Pathology, the cloud version of Roche ’s uPath enterprise software. This collaboration is now possible through Roche’s Digital Pathology Open Environment, which allows pathologists to secu...
Source: Roche Investor Update - October 15, 2021 Category: Pharmaceuticals Source Type: news
FDA accepts REGEN-COV (casirivimab and imdevimab) for priority review for treatment and prophylaxis of COVID-19
Dear Investor,Please find attached a press release from our partner Regeneron:https://investor.regeneron.com/news-releases/news-release-details/fda-accepts-regen-covr-casirivimab-and-imdevimab-priority-reviewDo not hesitate to contact us for any further questions.With best regards, (Source: Roche Investor Update)
Source: Roche Investor Update - October 14, 2021 Category: Pharmaceuticals Source Type: news
Invitation to Roche ’s Virtual Event " Digitalization along the value chain "
(Source: Roche Investor Update)
Source: Roche Investor Update - October 14, 2021 Category: Pharmaceuticals Source Type: news
New four-year data show Roche's ENSPRYNG significantly reduces debilitating relapses in people with neuromyelitis optica spectrum disorder
Basel, 14 October 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new longer-term efficacy and safety data for ENSPRYNG® (satralizumab). The data show ENSPRYNG has a favourable benefit:risk profile and is effective in reducing relapses over four years of treatment in people with anti-aquaporin-4 antibody (AQP 4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), a rare debilitating disease that affects the central nervous system. Efficacy and safety results from the open-label extension (OLE) periods of the SAkuraStar and SAkuraSky studies, in addition to the design of SAkuraBONSAI, a new s tudy ...
Source: Roche Investor Update - October 14, 2021 Category: Pharmaceuticals Source Type: news
Roche ’s Gazyvaro shorter 90-minute infusion time approved in Europe for people with previously treated or untreated follicular lymphoma
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced European Medicines Agency (EMA) approval of a new, shorter 90-minute Gazyvaro ® (obinutuzumab) infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma (FL). (Source: Roche Investor Update)
Source: Roche Investor Update - October 14, 2021 Category: Pharmaceuticals Source Type: news
Reminder: Invitation to Roche ’s 3rd Quarter Sales 2021 Webinar
(Source: Roche Investor Update)
Source: Roche Investor Update - October 13, 2021 Category: Pharmaceuticals Source Type: news
Data up to 8-years for Roche ’s OCREVUS (ocrelizumab) show early and ongoing treatment significantly reduced risk of requiring a walking aid in relapsing multiple sclerosis and disability progression in primary progressive multiple sclerosis
Basel, 13 October 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new long-term data that reinforce the benefit of early initiation and ongoing treatment of OCREVUS® (ocrelizumab) on disability progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS), as well as safety outcomes for an analysis of shorter 2-hour infusion in minority populations. OCREVUS data from all clinical trials consistently show a favourable benefit-risk profile over eight years. Roche and research partners will also present four late-breaking abstracts to share the latest data regarding COVID-19 and vaccine resp...
Source: Roche Investor Update - October 13, 2021 Category: Pharmaceuticals Source Type: news
Chugai files for additional indications of Ronapreve for prophylaxis and treatment of asymptomatic COVID-19
Dear Investor,Please find attached a press release by Chugai:https://www.roche.com/211011_IR_Chugai_eRonapreve NDA.pdfDo not hesitate to contact us for any further questions.With best regards, (Source: Roche Investor Update)
Source: Roche Investor Update - October 11, 2021 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche ’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease
Basel, 8 October 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s di sease (AD). This designation is based on data showing that gantenerumab significantly reduced brain amyloid plaque, a pathological hallmark of AD, in the ongoing SCarlet RoAD and Marguerite RoAD open-label extension trials, as well as other studies. Learnings from these studies have been incorporate d into...
Source: Roche Investor Update - October 8, 2021 Category: Pharmaceuticals Source Type: news
Roche to present new data on OCREVUS in multiple sclerosis and ENSPRYNG in neuromyelitis optica spectrum disorder at ECTRIMS 2021
Basel, 5 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new OCREVUS ® (ocrelizumab) and ENSPRYNG® (satralizumab) data will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from 13 - 15 October 2021. These data include 38 abstracts highlighting new longer-term efficacy and safety for both OCREVUS and ENSPRYNG, as well as our ongoing efforts to evaluate the impact of the COVID-19 pandemic for people living with MS. Additional data will show how a deeper scientific understanding of MS and NMOSD in diverse patient populations could ...
Source: Roche Investor Update - October 5, 2021 Category: Pharmaceuticals Source Type: news
Phase II/III trial shows Ronapreve ™ (casirivimab and imdevimab) significantly reduces viral load within seven days of treatment in patients hospitalised with COVID-19
Basel, 30 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive data from the phase II/III 2066 study, investigating Ronapreve ™ (casirivimab and imdevimab) in patients hospitalised with COVID-19. The trial met its primary endpoint, showing that Ronapreve significantly reduced viral load within seven days of treatment in patients who had not mounted a natural antibody response of their own (seronegative) and who required low-flow or no supplemental oxygen (p=0.0172). Full results of the study will be presented at ID Week 2021 today. (Source: Roche Investor Update)
Source: Roche Investor Update - September 30, 2021 Category: Pharmaceuticals Source Type: news
Roche presents new data at World Muscle Society (WMS) 2021 highlighting new advances for people living with rare neuromuscular disorders
Basel, 24 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced data from across its growing neuromuscular portfolio at the World Muscle Society (WMS) Virtual Congress 20 – 24 September 2021. The presentations included additional results from the RAINBOWFISH study, evaluating the efficacy and safety of Evrysdi® (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA) from birth to six weeks of age and data supporting the continued clinical investig ation of gene therapy, SRP-9001, in Duchenne muscular dystrophy (DMD).“These new data for Evrysdi may help extend the potential benefits of th...
Source: Roche Investor Update - September 24, 2021 Category: Pharmaceuticals Source Type: news
Roche launches three respiratory test panels on cobas 6800/8800 Systems in CE markets to help identify multiple pathogens with overlapping symptoms in patients
Basel, 22 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of three molecular PCR diagnostic test panels to simultaneously detect and differentiate common respiratory pathogens: (Source: Roche Investor Update)
Source: Roche Investor Update - September 22, 2021 Category: Pharmaceuticals Source Type: news
New Phase III data support the benefit of Roche ’s Tecentriq in early-stage lung cancer
Basel, 20 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented new data from the Phase III IMpower010 study at the European Society for Medical Oncology (ESMO) Congress 2021 Presidential Symposium, reinforcing the significant disease-free survival (DFS) benefit offered by Tecentriq ® (atezolizumab) for people with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%. Data from the IMpower010 trial were published simultaneously in The Lancet. In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the risk of disease re currence or death (DFS) by 34% ...
Source: Roche Investor Update - September 20, 2021 Category: Pharmaceuticals Source Type: news
