[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. The Pharma Division began to grow again in the second quarter. The base diagnostics business shows str ong momentum. (Source: Roche Investor Update)
Source: Roche Investor Update - 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 Investor Update - 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 Investor Update)
Source: Roche Investor Update - 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 Investor Update - 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 Investor Update)
Source: Roche Investor Update - 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 Investor Update)
Source: Roche Investor Update - July 2, 2021 Category: Pharmaceuticals Source Type: news

Atea ’s AT-527, an oral antiviral drug candidate reduces viral replication in hospitalized patients with COVID-19 in phase 2 interim analysis
Dear Investor,Please find attached a press release from our partner Atea Pharmaceuticals:https://ir.ateapharma.com/news-releases/news-release-details/ateas-527-oral-antiviral-drug-candidate-reduces-viralDo not hesitate to contact us for any further questions.With best regards, (Source: Roche Investor Update)
Source: Roche Investor Update - June 30, 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 Investor Update - June 28, 2021 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s Half Year Results 2021 Presentation
  (Source: Roche Investor Update)
Source: Roche Investor Update - June 25, 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 Investor Update - 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 Investor Update - June 24, 2021 Category: Pharmaceuticals Source Type: news

Chugai obtains regulatory approval for Evrysdi for the treatment of Spinal Muscular Atrophy
Dear Investor,Please find attached a press release by Chugai:https://www.roche.com/210623_IR_Chugai_eEvrysdi_approval.pdfDo not hesitate to contact us for any further questions.With best regards, (Source: Roche Investor Update)
Source: Roche Investor Update - June 23, 2021 Category: Pharmaceuticals Source Type: news

REGEN-COV ™ (casirivimab and imdevimab) phase 3 RECOVERY trial meets primary outcome, improving survival in hospitalized COVID-19 patients lacking an immune response to SARS-CoV-2
Dear Investor,Please find attached a press release from our partner Regeneron:https://investor.regeneron.com/news-releases/news-release-details/regen-covtm-casirivimab-and-imdevimab-phase-3-recovery-trialDo not hesitate to contact us for any further questions.With best regards, (Source: Roche Investor Update)
Source: Roche Investor Update - June 16, 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 Investor Update - 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 Investor Update - 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 Investor Update)
Source: Roche Investor Update - 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 Investor Update - June 8, 2021 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to Roche ’s virtual event on key Evrysdi data presented at the 2021 CureSMA Annual Meeting
  (Source: Roche Investor Update)
Source: Roche Investor Update - June 7, 2021 Category: Pharmaceuticals Source Type: news

Roche presents data on giredestrant, a next generation selective oestrogen receptor degrader for people with hormone receptor-positive, HER-2 negative breast cancer
Basel, 4 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the presentation of new and updated data on giredestrant (formerly known as GDC-9545), an investigational next generation oral selective oestrogen receptor degrader (SERD), in people with hormone receptor (HR)-positive, HER2-negative breast cancer. Breast cancer is now the most common cancer in the world, with HR-positive being the most common subtype representing 70% of cases.1,2 Data from these studies will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held June 4-8, 2021.“We’re encour...
Source: Roche Investor Update - June 4, 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 Investor Update)
Source: Roche Investor Update - June 4, 2021 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to Roche ’s virtual event on key oncology data presented at 2021 ASCO Annual Meeting
  (Source: Roche Investor Update)
Source: Roche Investor Update - May 31, 2021 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s virtual event on key Evrysdi data presented at the 2021 CureSMA Annual Meeting
  (Source: Roche Investor Update)
Source: Roche Investor Update - May 26, 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 Investor Update)
Source: Roche Investor Update - 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 Investor Update)
Source: Roche Investor Update - 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 Investor Update - 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 Investor Update)
Source: Roche Investor Update - May 5, 2021 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s virtual event on key oncology data presented at 2021 ASCO Annual Meeting
Invitation to Roche ’s virtual event on key oncology data presented at 2021 ASCO Annual Meeting (Source: Roche Investor Update)
Source: Roche Investor Update - April 30, 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 Investor Update - 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 Investor Update - 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 Investor Update - April 27, 2021 Category: Pharmaceuticals Source Type: news

Roche announces positive CHMP opinion for Venclyxto-based combinations in certain patients with acute myeloid leukaemia
Basel, 23 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto® (venetoclax) in combination with a hypomethylating agent for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. Bas ed on this positive CHMP recommendation, a final decision regarding the approval of Venclyxto in certain patients with untreated AML is expected from the European Commission in the near future.“Today’s...
Source: Roche Investor Update - April 23, 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 Investor Update - 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 Investor Update)
Source: Roche Investor Update - 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 Investor Update)
Source: Roche Investor Update - 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 Investor Update)
Source: Roche Investor Update - 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 Investor Update - 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 Investor Update - 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 Investor Update - 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 Investor Update - 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 Investor Update - 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 Investor Update - 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 Investor Update)
Source: Roche Investor Update - 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 Investor Update)
Source: Roche Investor Update - 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 Investor Update - 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 Investor Update)
Source: Roche Investor Update - March 25, 2021 Category: Pharmaceuticals Source Type: news

Chugai: Polivy approved for treatment of relapsed or refractory diffuse large B-cell lymphoma in Japan
Dear Investor, Please find attached a press release by Chugai:https://www.roche.com/dam/jcr:886cf513-18db-4809-a7d5-de8b66ca4b0e/en/210324_IR_Chugai_ePolivy_Approval.pdf Do not hesitate to contact us for any further questions. With best regards, (Source: Roche Investor Update)
Source: Roche Investor Update - March 24, 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 Investor Update - 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 Investor Update - March 23, 2021 Category: Pharmaceuticals Source Type: news

Roche provides update on tominersen programme in manifest Huntington ’s disease
             Basel, 22 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the decision to discontinue dosing in the Phase III GENERATION HD1 study of tominersen in manifest Huntington ’s disease (HD). The decision was based on the results of a pre-planned review of the data from the Phase III study conducted by an unblinded Independent Data Monitoring Committee (iDMC). The iDMC made its recommendation based on the investigational therapy’s potential benefit/risk profile for s tudy participants. No new or emerging safety signals were i...
Source: Roche Investor Update - March 22, 2021 Category: Pharmaceuticals Source Type: news

Pivotal Phase III study shows Roche ’s Tecentriq helped people with early lung cancer live longer without their disease returning
Basel, 22 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpower010 study evaluating Tecentriq® (atezolizumab), compared with best supportive care (BSC), met its primary endpoint of disease-free survival (DFS) at the interim analysis. Tecentriq showed a statistically significant im provement in DFS as adjuvant therapy following surgery and chemotherapy in all randomised Stage II-IIIA populations with non-small cell lung cancer (NSCLC). The magnitude of DFS benefit was particularly pronounced in the PD-L1-positive population. Follow-up will continue with planned analyses of DFS ...
Source: Roche Investor Update - March 22, 2021 Category: Pharmaceuticals Source Type: news