Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19
Basel, 20 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Japan ’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve™(casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals an d Medical Devices Act. (Source: Roche Media News)
Source: Roche Media News - July 20, 2021 Category: Pharmaceuticals Source Type: news
New data for Roche ’s Hemlibra reinforce safety profile in people with haemophilia A
Basel, 19 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the final analysis of the phase IIIb STASEY study, which confirm the favourable safety profile of Hemlibra ® (emicizumab), consistent with the phase III HAVEN clinical programme.1,2,3,4 In the analysis, no new safety signals were identified with longer-term Hemlibra treatment in adults and adolescents with haemophilia A with inhibitors to factor VIII, the clotting protein that is missing or defective in people with haemophilia A. The data were presented at the virtual International Society on Thrombosis and Haemostasis (ISTH) 2021 Congre...
Source: Roche Media News - July 19, 2021 Category: Pharmaceuticals Source Type: news
WHO guidelines now include Roche ’s diagnostic tests in expanded effort to eliminate tuberculosis by providing patients greater access to timely diagnosis
Basel, 09 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the cobas ® MTB and cobas® MTB-RIF/INH tests for use on the cobas® 6800/8800 Systems are included as part of the updated World Health Organization (WHO) policy guidelines on nucleic acid amplification tests (NAATs) to detect tuberculosis (TB) and drug-resistant TB. The new guidance expands the number of ra pid molecular tests available to national TB programmes in high-burden countries, enabling multi-partner diagnostic approaches that can benefit patients and communities. (Source: Roche Media News)
Source: Roche Media News - July 9, 2021 Category: Pharmaceuticals Source Type: news
Roche to present new data at the ISTH 2021 Congress highlighting long-standing commitment to advancing haemophilia A standard of care
Basel, 02 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its haemophilia A clinical programme will be presented at the virtual International Society on Thrombosis and Haemostasis (ISTH) 2021 Congress, from 17-21 July 2021. Data will include the final analysis from the phase IIIb STASEY study of Hemlibra ® (emicizumab) and updated data from the phase I/II study of SPK-8011, an AAV-based gene therapy in development by Spark Therapeutics (a member of the Roche Group).1,2 (Source: Roche Media News)
Source: Roche Media News - July 2, 2021 Category: Pharmaceuticals Source Type: news
Roche ’s ENSPRYNG approved by European Commission as first and only at-home subcutaneous treatment for neuromyelitis optica spectrum disorder (NMOSD)
Basel, 28 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has approved ENSPRYNG ® (satralizumab) for the treatment of adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). ENSPRYNG is the first and only NMO SD treatment that is administered subcutaneously every four weeks, allowing home-dosing after appropriate training.“An NMOSD relapse can be devastating, causing permanent neurological damage and dis...
Source: Roche Media News - June 28, 2021 Category: Pharmaceuticals Source Type: news
Roche ’s Actemra/RoActemra receives U.S. FDA Emergency Use Authorization for the treatment of COVID-19 in hospitalised adults and children
Basel, 25 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra/RoActemra ® (tocilizumab) for the treatment of COVID-19 in hospitalised adults and paediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The E UA is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-1...
Source: Roche Media News - June 25, 2021 Category: Pharmaceuticals Source Type: news
FDA accepts application for Roche ’s Port Delivery System with ranibizumab (PDS) for treatment of neovascular or “wet” age-related macular degeneration (nAMD)
Basel, 24 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Neovascular AMD is a leading cause of blindness for people aged 60 and over and impacts approximatel y 20 million people worldwide.1,2,3 If approved, PDS would be a first-of-its-kind therapeutic approach, offering people living with nAMD an alternative to frequent eye injections of...
Source: Roche Media News - June 24, 2021 Category: Pharmaceuticals Source Type: news
Roche data at EAN 2021 showcase significant impact of therapies across diverse neuroscience portfolio
Basel, 15 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that data across its growing neuroscience portfolio will be presented at the 7th Congress of the European Academy of Neurology (EAN) Annual Meeting being held virtually 19-22 June, 2021. These new and encore data demonstrate Roche ’s commitment to advancing the clinical understanding of a broad range of neurological disorders with the goal of meeting the needs of people living with both the rarest and most common conditions.“Our data at EAN and recent European regulatory milestones for EVRYSDI and ENSPRYNG reflect our continued commitment to disco...
Source: Roche Media News - June 15, 2021 Category: Pharmaceuticals Source Type: news
Roche announces data at EHA2021 reinforcing efficacy of Venclexta/Venclyxto combinations in chronic lymphocytic leukaemia and acute myeloid leukaemia
Basel, 11 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the latest data from three pivotal phase III studies of Venclexta ®/Venclyxto® (venetoclax) – CLL14, MURANO and VIALE-A – to be presented at the European Hematology Association Virtual Congress, June 9-17 (EHA2021). Long-term follow-up data from the CLL14 and MURANO studies support the primary analysis of Venclexta/Venclyxto in chronic lymphocytic leukaemia (CLL) and the possibility of tailoring treatment approaches based on genetic risk factors. Furthermore, the latest research shows the potential of minimal residual disease (MRD) as a key meas...
Source: Roche Media News - June 11, 2021 Category: Pharmaceuticals Source Type: news
New Roche data for Evrysdi show improved motor function in pre-symptomatic babies after one year and confirm safety profile in previously treated people with spinal muscular atrophy (SMA)
Basel, 11 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new interim data from two studies of Evrysdi ® (risdiplam); JEWELFISH and RAINBOWFISH. Data from JEWELFISH, an ongoing open-label study primarily evaluating the safety of Evrysdi in people aged 1 to 60 years who have been previously treated with another SMA-targeting therapy, including nusinersen and onasemnogene abeparvovec, showed the safet y profile of Evrysdi and increase in SMN protein levels are consistent with those observed in other Evrysdi studies. (Source: Roche Media News)
Source: Roche Media News - June 11, 2021 Category: Pharmaceuticals Source Type: news
Roche obtains CE mark for the SARS-CoV-2 Antigen Self Test Nasal allowing for rapid self testing of COVID-19 at home
Basel, 08 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has received CE mark for its SARS-CoV-2 Antigen Self Test Nasal for at-home testing. The test will be available in countries accepting the CE mark through pharmacies and other locations, in packs of five tests.An early version of the test has already been available as a home-test in a number of European markets under local special approval pathways since February 2021. With the CE Mark, the SARS-CoV-2 Antigen Self Test Nasal for rapid self testing of COVID-19 test has received official approval following the traditional registration pathway and can...
Source: Roche Media News - June 8, 2021 Category: Pharmaceuticals Source Type: news
Roche presents latest advances with immunotherapies in non-Hodgkin lymphoma
Basel, 4 June 2021 ‒ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data on its investigational CD20xCD3 T-cell engaging bispecific antibodies, mosunetuzumab and glofitamab, and its first-in-class anti-CD79b antibody-drug conjugate, Polivy® (polatuzumab vedotin), in non-Hodgkin lymphoma (NHL) will be p resented at the 2021 ASCO Annual Meeting from 4-8 June 2021. (Source: Roche Media News)
Source: Roche Media News - June 4, 2021 Category: Pharmaceuticals Source Type: news
European Commission approves Venclyxto-based combinations for adults with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy
Basel, 25 May 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Venclyxto ® (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. (Source: Roche Media News)
Source: Roche Media News - May 25, 2021 Category: Pharmaceuticals Source Type: news
Pivotal Phase III data at ASCO show Roche ’s Tecentriq helps certain people with early lung cancer live significantly longer without their disease returning
Basel, 20 May 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced interim results from the Phase III IMpower010 study, showing for the first time that treatment with Tecentriq® (atezolizumab) following surgery and chemotherapy reduced the risk of disease recurrence or death (disease-free survival; DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) in people with Stage II-IIIA non-small cell lung cancer (NSCLC), whose tumours express PD-L1≥1%, compared with best supportive care (BSC). In this population, median DFS was not yet reached for Tecentriq compared with 35.3 months for BSC. (Source: Roche Media News)
Source: Roche Media News - May 20, 2021 Category: Pharmaceuticals Source Type: news
Roche to present data from one of the most comprehensive oncology portfolios at the 2021 ASCO Annual Meeting showcasing advancements for people living with cancer
Basel, 11 May 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from clinical trials of 19 approved and investigational medicines across 20 cancer types will be presented at the 2021 ASCO Annual Meeting, which will be held 4-8 June, 2021. A total of 132 abstracts that include a Roche medicine will be presented at this year ' s meeting. These data advance oncology by showing the importance of making patient-centric treatment decisions and providing tailored medical care based on specific cancer types.“We will be presenting data from across our diverse oncology portfolio that has the potential to help...
Source: Roche Media News - May 11, 2021 Category: Pharmaceuticals Source Type: news
