CHMP recommends EU approval of Ronapreve to treat non-hospitalised COVID-19 patients and for prophylaxis of the disease
Basel, 11 November 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of the antibody combination, Ronapreve™ (casirivimab and imdevimab), for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplement al oxygen and who are at increased risk of their disease becoming severe, and for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms (pre- or post-exposure prophylaxis). A final decis...
Source: Roche Media News - November 11, 2021 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche announces the repurchase of the equity stake held by Novartis in Roche
Basel, 4 November 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Novartis have announced today that they agreed on a repurchase by Roche of the 53.3 million Roche shares held by Novartis. The aggregate transaction value is approx. CHF 19 billion. The price per share is CHF 356.9341. It corresponds to the volume weighted average price of the Roche non-voting equity certificates over the last 20 trading days up to and including 2 November 2021. The Board of Directors of Roche has approved the envisaged repurchase, which will be debt-financed by Roche. All shareholders and holders of non-voting equity certificates of Roche ben...
Source: Roche Media News - November 4, 2021 Category: Pharmaceuticals Source Type: news
IMPACT trial data shows clear benefit in using Roche's CINtec PLUS Cytology test for women who are at higher risk of developing cervical cancer
IMPACT trial data shows clear benefit in using Roche ' sCINtec PLUS Cytology test for women who are at higher risk of developing cervical cancer (Source: Roche Media News)
Source: Roche Media News - October 29, 2021 Category: Pharmaceuticals Source Type: news
Roche launches comprehensive genomic profiling kit to expand access to personalised cancer research
Basel, 25 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has launched the AVENIO Tumor Tissue CGP Kit. The Kit complements the current CGP portfolio offered by Roche and Foundation Medicine and allows laboratories to expand their oncology research in-house. Ultimately, a future version of the kit may lead to additional resources for clinicians to use in the diagnosis and treatment of cancer. (Source: Roche Media News)
Source: Roche Media News - October 25, 2021 Category: Pharmaceuticals Source Type: news
FDA approves Roche ’s Susvimo, a first-of-its-kind therapeutic approach for neovascular or “wet” age-related macular degeneration (nAMD)
Basel, 22 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo ™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with neovascular or “wet” age-related macular degeneration (nAMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Neovascular AMD is a potentially blinding condition that requires treatment with eye injections as often as once a month.1,2,3,4 Susvimo, previously called Port Delivery System with ranibizumab, is the f...
Source: Roche Media News - October 22, 2021 Category: Pharmaceuticals Source Type: news
Roche ’s VENTANA PD-L1 (SP263) Assay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq® (atezolizumab)
Basel, 22 October 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA PD-L1 (SP263) Assay in non- small cell lung cancer (NSCLC) as a companion diagnostic test for Tecentriq, advancing the company ' s commitment to guide clinical decision making through innovative, high quality assays that improve patient access to personalized healthcare. (Source: Roche Media News)
Source: Roche Media News - October 22, 2021 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong growth in the first nine months – outlook for 2021 raised
CEO Severin Schwan on the results: “The demand for coronavirus tests remained high in the third quarter due to the Delta variant. (Source: Roche Media News)
Source: Roche Media News - October 20, 2021 Category: Pharmaceuticals Source Type: news
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 Media News)
Source: Roche Media News - 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 Media News - October 15, 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 Media News - 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 Media News)
Source: Roche Media News - October 14, 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 Media News - October 13, 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 Media News - 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 Media News - 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 Media News)
Source: Roche Media News - September 30, 2021 Category: Pharmaceuticals Source Type: news
