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 ben...
Source: Roche Media News - 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 Media News)
Source: Roche Media News - 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 ...
Source: Roche Media News - September 20, 2021 Category: Pharmaceuticals Source Type: news

Roche receives positive CHMP opinion for Gavreto ® (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer
Basel, 17 September 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 Gavreto® (pralsetinib) as a monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated w ith a RET inhibitor. (Source: Roche Media News)
Source: Roche Media News - September 17, 2021 Category: Pharmaceuticals Source Type: news

Roche opens access to pathology imaging tools to improve patient care
Basel, 15 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the introduction of theRoche Digital Pathology Open Environment that allows software developers to easily integrate their image analysis tools for tumour tissue with Roche ’s uPath enterprise software, an application for pathologist workflow. This open environment allows for the secure exchange and flow of data so that pathologists can access advanced algorithms from third parties alongside Roche’s menu of artificial intelligence-based image analysis tools. This e nables software developers globally to distribute their digital product...
Source: Roche Media News - September 15, 2021 Category: Pharmaceuticals Source Type: news

Roche signs definitive share purchase agreement with long-term partner TIB Molbiol to expand PCR-test portfolio in the fight against new infectious diseases
Basel, 09 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has signed a definitive share purchase agreement to acquire 100% of the outstanding shares of the TIB Molbiol Group. Closing of the transaction is subject to customary conditions and is expected in the fourth quarter of 2021. (Source: Roche Media News)
Source: Roche Media News - September 9, 2021 Category: Pharmaceuticals Source Type: news

Roche to present data from industry leading portfolio at ESMO 2021 showing significant progress in early stage and uncommon cancers
Basel, 07 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new oncology data will be presented at the European Society for Medical Oncology (ESMO) Congress, which will be held 16-21 September, 2021. With one of the broadest oncology pipelines and portfolios in the industry, Roche presentations include late-breaking abstracts featuring data in early-stage breast cancer and early-stage lung cancer, and a presentation on cancer of unknown primary (CUP), which has been selected for inclusion in the ESMO Press Programme. (Source: Roche Media News)
Source: Roche Media News - September 7, 2021 Category: Pharmaceuticals Source Type: news

Roche provides update on Tecentriq US indication for PD-L1-positive, metastatic triple-negative breast cancer
Basel, 27 August 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the company has made the decision to voluntarily withdraw the US accelerated approval for Tecentriq ® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumours express PD-L1, as determined by a US Food and Drug Administration (FDA)-approved test. Roche made this decision following consultation with the US FDA, based on the agency’s assessment of the current mTN...
Source: Roche Media News - August 27, 2021 Category: Pharmaceuticals Source Type: news

Roche receives FDA approval for first companion diagnostic to identify dMMR solid tumour patients eligible for anti-PD-1 immunotherapy
Basel, 18 August 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel, advancing the company's commitment to personalised healthcare through tests that determine which patients are most likely to benefit from specific and targeted therapies. The VENTANA MMR RxDx Panel is the first companion diagnostic test to aid in identifying patients whose solid tumours are deficient in DNA mismatch repair (MMR), who may be eligible for JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD-1 immunotherapy from GSK. The test evaluates a panel of MMR p...
Source: Roche Media News - August 18, 2021 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Phase III study shows Roche's Polivy plus R-CHP is the first regimen in 20 years to significantly improve outcomes in previously untreated aggressive form of lymphoma compared to standard of care
Basel, 9 August 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the pivotal phase III POLARIX trial investigating Polivy ® (polatuzumab vedotin) in combination with MabThera®/Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) versus MabThera/Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), met its primary endpoint by demonstrating significantly improved an d clinically meaningful progression-free survival in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Safety outcomes were consistent with those seen in previous...
Source: Roche Media News - August 9, 2021 Category: Pharmaceuticals Source Type: news

US FDA grants Priority Review to Roche ’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer
Basel, 3 August 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%, as determined by an FDA-appro ved test. The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and ef...
Source: Roche Media News - August 3, 2021 Category: Pharmaceuticals Source Type: news

FDA accepts application for Roche ’s faricimab for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)
Basel, 29 July 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 faricimab for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). The FDA has also accepted the company’s submission for diabetic retinopathy.Faricimab will be the first and only bispecific antibody designed for the eye, if approved. It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growt...
Source: Roche Media News - July 29, 2021 Category: Pharmaceuticals Source Type: news

Data for Roche ’s Evrysdi® (risdiplam) published in New England Journal of Medicine shows significant improvement in survival and motor milestones in babies with Type 1 spinal muscular atrophy (SMA)
Basel, 29 July 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the New England Journal of Medicine (NEJM) has published data from FIREFISH Part 2, a pivotal global study evaluating the efficacy and safety of Evrysdi® (risdiplam) in babies aged 1-7 months old with symptomatic Type 1 spinal muscular atr ophy (SMA). The study met its primary endpoint with 29% of infants (12/41) sitting without support for at least five seconds* by month 12, a milestone not seen in the natural course of the disease. Safety for Evrysdi in the FIREFISH Part 2 study was consistent with its known safety profile.“With...
Source: Roche Media News - July 29, 2021 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good half-year results
Commenting on the Group ’s performance in the first six months, Roche CEO Severin Schwan said: “We have achieved good results in the first half, primarily thanks to the demand for our new medicines and COVID-19 tests. (Source: Roche Media News)
Source: Roche Media News - July 22, 2021 Category: Pharmaceuticals Source Type: news

FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes
Basel, 21 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Venclexta ® (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the rev ised International Prognostic Scoring System (IPSS-R). MDS are a rare group of blood cancers that gradually affect the ability of the bone marrow to produce normal blood cells.2 This can lead to weakness, frequent infections, anaemia and ...
Source: Roche Media News - July 21, 2021 Category: Pharmaceuticals Source Type: news

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 Con...
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 ...
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 COVI...
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 i...
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 ...
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)...
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 he...
Source: Roche Media News - May 11, 2021 Category: Pharmaceuticals Source Type: news

Roche ’s Tecentriq approved by European Commission as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer
Basel, 5 May 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression*, with no epidermal growth factor rec eptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations. (Source: Roche Media News)
Source: Roche Media News - May 5, 2021 Category: Pharmaceuticals Source Type: news

US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche ’s Tecentriq for previously untreated metastatic bladder cancer
Basel, 28 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favour of maintaining accelerated approval of Tecentriq® (atezolizumab) for the treatment of adults with locally advanced or metastatic urothel ial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumours express high levels of PD-L1 (PD-L1–stained tumour-infiltrating immune cells covering ≥5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for ...
Source: Roche Media News - April 28, 2021 Category: Pharmaceuticals Source Type: news

Roche launches new ways to use their cardiovascular tests empowering clinicians to improve diagnosis and treatment of millions of people
Basel, 28 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced a series of five new intended uses for two key cardiac biomarkers using the Elecsys ® technology: high sensitive cardiac troponin T (cTnT-hs) and N-terminal pro-brain natriuretic peptide test (NT-proBNP). These gold standard biomarkers³ have proven to be successful in supporting cardiovascular disease management and can help clinicians diagnose heart attacks⁴ (cTnT-hs) and bett er manage heart failure⁵ (NT-proBNP). Roche's introduction of five new intended uses for these existing, globally accepted diagnostic solutions means more people could ...
Source: Roche Media News - April 28, 2021 Category: Pharmaceuticals Source Type: news

US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche ’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer
This study did not meet its primary endpoint of PFS for the initial (first-line) treatment of people with mTNBC in the PD-L1-positive population. As the clinically meaningful benefit demonstrated in the IMpassion130 study remains, Roche looks forward to continuing to work with the FDA to determine next steps with regard to Tecentriq in this indication.Roche remains committed to following the science to better understand cancer, including which patients may benefit most from immunotherapy treatment. Tecentriq has already demonstrated its transformational role in areas of high medical need and is a first in class medicine ap...
Source: Roche Media News - April 27, 2021 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s ENSPRYNG (satralizumab) for adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD)
Basel, 23 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ENSPRYNG® (satralizumab) as the first subcutaneous treatment option for adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spe ctrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). AQP4-IgG are present in around 70-80% of people with NMOSD, who tend to experience a more severe disease course.NMOS...
Source: Roche Media News - April 23, 2021 Category: Pharmaceuticals Source Type: news

Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy
Basel, 23 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. MMR is a molecular mechanism that functions to correct certain errors that can spontaneously occur during DNA replication. Testing can identify patients eligible for treatment with JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD1 immunotherapy from GlaxoSmithKline (GSK) that was approved by the FDA on 22 April 2021. (Source: Roche Media News)
Source: Roche Media News - April 23, 2021 Category: Pharmaceuticals Source Type: news

Roche purchases shares in tender offer for GenMark Diagnostics, Inc.
Basel, 22 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and GenMark Diagnostics, Inc. today announced that Roche ’s wholly owned subsidiary Geronimo Acquisition Corp. has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of GenMark Diagnostics, Inc. (NASDAQ: GNMK) at a price of USD 24.05 per share in cash. The te nder offer expired at 12:00 midnight, Eastern Time, at the end of the day on 21 April 2021 and was not extended. (Source: Roche Media News)
Source: Roche Media News - April 22, 2021 Category: Pharmaceuticals Source Type: news

Roche reports solid results in the first quarter of 2021
Group sales increase 3%1 at constant exchange rates (CER); 1% decline in Swiss francs, as a result of the appreciation of the Swiss franc (Source: Roche Media News)
Source: Roche Media News - April 21, 2021 Category: Pharmaceuticals Source Type: news

New data for Roche ’s OCREVUS (ocrelizumab) reinforce significant benefit on slowing disease progression in relapsing and primary progressive multiple sclerosis
Basel, 16 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new OCREVUS ® (ocrelizumab) analyses supporting its significant benefit on disease progression in early-stage relapsing-remitting multiple sclerosis (RRMS) and primary progressive MS (PPMS) as well as demonstrating high persistence and strong adherence to twice-yearly (six-monthly) dosing. These data are being presented virtually at the 73rd American Academy of Neurology (AAN) Annual Meeting from 17–22 April 2021. OCREVUS is the number one prescribed MS medication in the U.S. for patients starting a new treatment, and more than 200,000 peop...
Source: Roche Media News - April 16, 2021 Category: Pharmaceuticals Source Type: news

Roche ’s Evrysdi continues to improve motor function and survival in babies with Type 1 Spinal Muscular Atrophy (SMA)
Basel, 15 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new 2-year data from Part 2 of FIREFISH, a Phase 2/3 global study evaluating Evrysdi ™ (risdiplam) in infants aged 1-7 months at enrollment with symptomatic Type 1 spinal muscular atrophy (SMA). The data showed Evrysdi continued to improve motor function between months 12 and 24, including the ability to sit without support. The study also showed Evrysdi continued to improve survi val, improve ability to feed orally and reduce the need for permanent ventilation*. Exploratory data suggested Evrysdi continued to improve the ability to swallow and...
Source: Roche Media News - April 15, 2021 Category: Pharmaceuticals Source Type: news

FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications
●  Xolair for self-injection offers healthcare providers and appropriate patients another administration option for more flexibility in managing their treatmentBasel, 13 April 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved the company ’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. indications.1 Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic ...
Source: Roche Media News - April 13, 2021 Category: Pharmaceuticals Source Type: news

Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81%
Basel, 12 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive results from the phase III REGN-COV 2069 trial assessing the ability of the investigational antibody cocktail casirivimab and imdevimab to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals. The trial, which was jointly run with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), met its primary and key secondary endpoints. It showed that the subcutaneous administration of casirivimab and imdevimab reduced the risk of sym...
Source: Roche Media News - April 12, 2021 Category: Pharmaceuticals Source Type: news

New Roche data at 2021 AAN highlight impact and breadth of expanding neuroscience portfolio
             Basel, 8 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. These new data include 23 abstracts highlighting the expanding Roche neuroscience portfolio across six therapeutic areas, including EVRYSDI ™ (risdiplam) for spinal muscular atrophy (SMA), OCREVUS® (ocrelizumab) in relapsing and primary progre...
Source: Roche Media News - April 8, 2021 Category: Pharmaceuticals Source Type: news

Roche launches Elecsys Anti-p53 immunoassay to aid diagnosis of various cancer types
Basel, 07 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 antibodies. This test is used to aid physicians to diagnose throat cancer, bowel cancer and breast cancer in patients, in conjunction with other diagnostic tests. The assay is now available for all markets accepting the CE Mark.“The addition of our Elecsys Anti-p53 immunoassay will help clinicians to quickly and reliably diagnose several prevalent cancers and might assist in leading to a better prognosis for many patients.”, said Thomas ...
Source: Roche Media News - April 7, 2021 Category: Pharmaceuticals Source Type: news

Roche launches Elecsys Epstein-Barr Virus (EBV) immunoassay panel to improve EBV infection staging
Basel, 31 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Elecsys ® EBV panel has launched in countries accepting the CE Mark. Roche will file for approval with the FDA in the future. The Elecsys® EBV panel consists of three immunoassays: Elecsys EBV IgM, Elecsys EBV VCA IgG, and Elecsys EBV EBNA IgG, that detect antibodies specific to the Epstein-Barr virus (EB V), at different stages of infection. When used in combination, the three tests can help to define how far the infection has progressed in a patient. (Source: Roche Media News)
Source: Roche Media News - March 31, 2021 Category: Pharmaceuticals Source Type: news

Roche ’s Evrysdi approved by European Commission as first and only at home treatment for spinal muscular atrophy
Basel, 30 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved Evrysdi ™ (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients two months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. SMA is a leading genetic cause of death in infants and 5q SMA is the most common form of the disea se. The condition causes muscle weakness and progressive loss of movement and significant unmet need remains, particularly in adults living with this condition. (Source: Roche Media News)
Source: Roche Media News - March 30, 2021 Category: Pharmaceuticals Source Type: news

Roche receives positive CHMP opinion for Tecentriq as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer
Basel, 26 March 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 Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression*, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations. Based on this recommendation, a final decision regarding the approval of Tecentriq in this disease setting, along with the full deta...
Source: Roche Media News - March 26, 2021 Category: Pharmaceuticals Source Type: news

Roche commences tender offer for all shares of GenMark Diagnostics, Inc. for $24.05 per share in cash
Basel, 25 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has commenced a cash tender offer for all of the outstanding shares of common stock of GenMark Diagnostics, Inc. (NASDAQ: GNMK) at a price of $24.05 per share. The tender offer is being made pursuant to the previously announced merger ag reement dated as of March 12, 2021 among Roche Holdings, Inc., an indirect wholly owned subsidiary of Roche Holding Ltd, Geronimo Acquisition Corp., a wholly owned subsidiary of Roche Holdings, Inc., and GenMark. (Source: Roche Media News)
Source: Roche Media News - March 25, 2021 Category: Pharmaceuticals Source Type: news

Roche launches new high throughput configurations for cobas pro integrated solutions to increase testing efficiency
Basel, 23 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of eight new configurations forcobas pro integrated solutions, in countries accepting the CE mark. As a result, this analyser can deliver up to 4,400 tests per hour, doubling its previous testing capacity.1 This makes it the ideal choice for labs seeking greater flexibility in ramping up their testing capacity, to adapt to evolving clinical chemistry and immunochemistry testing needs. Today, the importance of accurate and timely diagnostic testing can be felt across the globe. Growing testing demands put laboratories under significan...
Source: Roche Media News - March 23, 2021 Category: Pharmaceuticals Source Type: news

New phase III data shows investigational antibody cocktail casirivimab and imdevimab reduced hospitalisation or death by 70% in non-hospitalised patients with COVID-19
             Basel, 23 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalised patients (n=4,567; REGN-COV 2067). The phase III outcomes trial in high-risk non-hospitalised patients with COVID-19 met its primary endpoint, showing the investigational antibody cocktail of casirivimab and imdevimab reduced the risk of hospitalisation or death by 70% (1,200 mg intravenously [IV]) and 71% (2,400 mg IV) compared to placebo. Casirivimab and imd...
Source: Roche Media News - March 23, 2021 Category: Pharmaceuticals Source Type: news