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 has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of GenMark Diagnostics, Inc. (NASDAQ: GNMK) at a price of USD 24.05 per share in cash.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

Roche launches cobas pure integrated solutions analyser to help simplify operations in small to medium sized labs
Basel, 17 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch ofcobas pure integrated solutions in countries accepting the CE mark.3 This new compact analyser combines three technologies1 on a single platform helping to simplify daily operations in labs with limited space and resources. (Source: Roche Investor Update)
Source: Roche Investor Update - March 17, 2021 Category: Pharmaceuticals Source Type: news

Roche Annual General Meeting 2021
Basel, 16 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its shareholders approved all proposals of the Board of Directors at its ordinary Annual General Meeting (AGM). Owing to the pandemic restrictions, the AGM was held with only those persons required by the Articles of Incorporation in attendance and with no shareholders physically present. Roche shareholders were able to exercise their rights via written or electronically submitted instructions to the independent proxy, Testaris AG. The independent proxy represented 84.58% of the total of 160,000,000 shares. The Management Report, the Annual Fina...
Source: Roche Investor Update - March 16, 2021 Category: Pharmaceuticals Source Type: news

Roche launches SARS-CoV-2 variant test to help monitor emerging coronavirus mutations
Basel, 16 March 2021- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the cobas® SARS-CoV-2 Variant Set 1 Test to detect and differentiate mutations found in variants that originated in the UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1). This research use only laboratory test can be used to help scientists track mutation prevalence and to assess any potential impact on diagnostics, vaccines and therapeutics, providing crucial insight for healthcare systems in making appropriate measures to combat COVID-19. Variants of B.1.1.7, B.1.351 and P.1 lineage gained prominence in late 2020, with each ca...
Source: Roche Investor Update - March 16, 2021 Category: Pharmaceuticals Source Type: news

New two-year data show Roche ’s Evrysdi (risdiplam) continues to demonstrate improvement or maintenance of motor function in people aged 2-25 with Type 2 or Type 3 Spinal Muscular Atrophy (SMA)
Basel, 16 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new exploratory 2-year longer-term data from Part 2 of SUNFISH, a global placebo-controlled study evaluating Evrysdi ™ (risdiplam) in people aged 2-25 years with Type 2 or non-ambulant Type 3 spinal muscular atrophy (SMA). The study suggests that gains in motor function observed with Evrysdi treatment at month 12 continued to improve or were maintained at month 24 across primary and secondary endpoint measures. Based on the natural history of the disease, people with Types 2 and 3 SMA who remain untreated decline in motor function over time. Th...
Source: Roche Investor Update - March 16, 2021 Category: Pharmaceuticals Source Type: news

Roche signs definitive merger agreement with GenMark Diagnostics, Inc., to access novel technology to test for broad range of pathogens with one patient sample
Roche and GenMark Diagnostics (NASDAQ: GNMK) today announced that they have entered into a definitive merger agreement for Roche to fully acquire GenMark at a price of US$ 24.05 per share in an all-cash transaction. (Source: Roche Investor Update)
Source: Roche Investor Update - March 15, 2021 Category: Pharmaceuticals Source Type: news

Roche awarded WHO prequalification for the HIV and HCV tests on the cobas 6800/8800 Systems
Basel, 11 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the cobas ® HIV-1 and cobas® HCV Tests for use on the cobas® 6800/8800 Systems have been awarded World Health Organization (WHO) prequalification. WHO prequalification helps regulators and procurers in low and middle-income countries to identify products that meet high quality standards and are safe and su itable for their intended use. This is of benefit to healthcare professionals and patients, for whom quality assured IVDs are essential for effective diagnosis and monitoring of therapeutic efficiency.  Increased access to dia...
Source: Roche Investor Update - March 11, 2021 Category: Pharmaceuticals Source Type: news

Roche provides update on the phase III REMDACTA trial of Actemra/RoActemra plus Veklury in patients with severe COVID-19 pneumonia
Basel, 11 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the global phase III randomised, double-blind, multicentre REMDACTA study of Actemra ®/RoActemra® (tocilizumab) plus Veklury® (remdesivir), versus placebo plus Veklury, did not meet its primary endpoint. This was measured by improved time to hospital discharge up to day 28 in patients with severe COVID-19 pneumonia receiving standard of care. No new safety signals were identified for Actemra/RoActemra in the REMDACTA trial. The study was conducted in collaboration with Gilead Sciences, Inc. (Source: Roche Investor Update)
Source: Roche Investor Update - March 11, 2021 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to the Roche Diagnostics Investor Day 2021: Innovating diagnostics, shaping healthcare, changing lives
(Source: Roche Investor Update)
Source: Roche Investor Update - March 8, 2021 Category: Pharmaceuticals Source Type: news

Roche provides update on Tecentriq US indication in prior-platinum treated metastatic bladder cancer
This study did not meet its primary endpoint of overall survival in the PD-L1 high patient population. Subsequently, the FDA designated the IMvigor130 study as the PMR which will still continue until the final analysis. However, as the treatment landscape in prior-platinum (second-line) mUC has rapidly evolved with the emergence of new treatment options, Roche is voluntarily withdrawing this indication in recognition of the principles of the Accelerated Approval Program.About Tecentriq Tecentriq is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (PD-L1), which is expressed on tumour c...
Source: Roche Investor Update - March 8, 2021 Category: Pharmaceuticals Source Type: news

Roche ’s Actemra/RoActemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease, a rare, debilitating condition
Basel, 05 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) approved Actemra®/RoActemra® (tocilizumab) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a debilitating condition with limited treatment options. Actemra/RoActemra is the first biologic therapy approved by the FDA for the treatment of the disease. Systemic sclerosis (SSc), also known as scleroderma, is an often devastating autoimmune disease that worsens over time and has no ...
Source: Roche Investor Update - March 5, 2021 Category: Pharmaceuticals Source Type: news

Roche SARS-CoV-2 Rapid Antigen Test receives special approval for at-home patient self-testing using nasal swabs in Germany
Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has been granted special approval by the German Federal Institute for Drugs and Medical Devices (BfArM) to offer the SARS-CoV-2 Rapid Antigen Test using a simple nasal swab for patient self-testing in Germany. (Source: Roche Investor Update)
Source: Roche Investor Update - February 26, 2021 Category: Pharmaceuticals Source Type: news

EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19
Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) confirmed today that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a scientific opinion supporting the use of the investigational antibody cocktail, casirivimab and imdevimab, as a treatment option for patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. (Source: Roche Investor Update)
Source: Roche Investor Update - February 26, 2021 Category: Pharmaceuticals Source Type: news

Roche receives positive CHMP opinion for Evrysdi, the first and only at home spinal muscular atrophy (SMA) treatment with proven efficacy in adults, children and infants two months and older
Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Evrysdi ™ (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients 2 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 disease . SMA causes progressive muscle weakness and atrophy, and significant unmet need remains, particularly in adults ...
Source: Roche Investor Update - February 26, 2021 Category: Pharmaceuticals Source Type: news

Independent Data Monitoring Committee finds clear efficacy for REGEN-COV ™ (casirivimab with imdevimab) in Phase 3 COVID-19 outpatient outcomes trial
Dear Investor, Please find attached a press release from our partner Regeneron: (Source: Roche Investor Update)
Source: Roche Investor Update - February 25, 2021 Category: Pharmaceuticals Source Type: news

Invitation to the Roche Diagnostics Investor Day 2021: Innovating diagnostics, shaping healthcare, changing lives
We are pleased to invite investors and analysts to participate in our virtual event on Tuesday, 23 March 2021 highlighting future growth drivers of the Division. (Source: Roche Investor Update)
Source: Roche Investor Update - February 25, 2021 Category: Pharmaceuticals Source Type: news

Roche announces results from Evrysdi (risdiplam) study in infants with Type 1 spinal muscular atrophy (SMA) published in New England Journal of Medicine
Basel, 25 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the New England Journal of Medicine has published Evrysdi ™ (risdiplam) data from the dose finding Part 1 of the pivotal FIREFISH study in infants with symptomatic Type 1 spinal muscular atrophy (SMA). The data show that treatment with Evrysdi at 12 months helped 90% (19/21) of these infants survive without permanent ventilation and 33% (7/21) sit withou t support for at least 5 seconds, which is not normally seen in the natural course of the disease. The study also found that treatment with Evrysdi increased the levels of survival of m...
Source: Roche Investor Update - February 25, 2021 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s virtual event on 24-month data of Evrysdi in patients with type 2 or type 3 spinal muscular atrophy presented at the 2021 MDA virtual conference
We are pleased to invite investors and analysts to participate in our virtual event on Friday, 19 March, 2021, highlighting Roche data presented during the 2021 Muscular Dystrophy Association - MDA -Virtual Clinical and Scientific Conference, from 15th to 18th February. (Source: Roche Investor Update)
Source: Roche Investor Update - February 19, 2021 Category: Pharmaceuticals Source Type: news

New phase III data show Roche ’s faricimab is the first investigational injectable eye medicine to extend time between treatments up to four months in two leading causes of vision loss, potentially reducing treatment burden for patients
Basel, 12 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced detailed results from four phase III studies of its investigational bispecific antibody, faricimab, for the treatment of diabetic macular edema (DME) and neovascular or “wet” age-related macular degeneration (nAMD). The studies consistently showed that faricimab, given at intervals of up to four months, offered non-inferior vision gains compared to aflibercept, given every two months. Approximately half of people eligible for extended dosing with faricimab were able to be treated every four months in the first year in the YOSEMITE and ...
Source: Roche Investor Update - February 12, 2021 Category: Pharmaceuticals Source Type: news

Reminder: Invitation to Roche ’s virtual event on key ophthalmology data presented at the Angiogenesis 2021 Meeting
We are pleased to invite investors and analysts to participate in our virtual event on Tuesday, 16 February, 2021, highlighting Roche data presented at the virtual Angiogenesis, Exudation, and Degeneration 2021 Meeting, from 12th to 13th February. (Source: Roche Investor Update)
Source: Roche Investor Update - February 9, 2021 Category: Pharmaceuticals Source Type: news

FDA grants Breakthrough Device Designation for Roche's Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients
Basel, 8 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to their Elecsys ® GDF-15 assay as a companion diagnostic (CDx) in cancer treatment. This in vitro diagnostic immunoassay is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumours for treatment with Pfizer Inc.'s (NYSE: PFE) investigational drug PF-06946860. (Source: Roche Investor Update)
Source: Roche Investor Update - February 8, 2021 Category: Pharmaceuticals Source Type: news

Roche reports solid results in 2020
Commenting on the Group ’s results, Roche CEO Severin Schwan said: “Roche continues to make important contributions to fighting the COVID-19 pandemic. We developed in record time a comprehensive portfolio of diagnostic solutions and entered new partnerships to develop and produce effective COVID-19 medicines. The deman d for our new medicines which benefit people living with serious conditions, such as cancer, multiple sclerosis, haemophilia and spinal muscular atrophy, remains high. Based on our rejuvenated portfolio and the significant progress made in developing our product pipeline, Roche is strongly positi...
Source: Roche Investor Update - February 4, 2021 Category: Pharmaceuticals Source Type: news

Roche announces the upcoming launch of the SARS-CoV-2 Rapid Antigen Test Nasal allowing for patient self-collection
Basel, 01 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has obtained the CE mark for its new SARS-CoV-2 Rapid Antigen Test Nasal. The test will be available in countries accepting the CE mark by mid-February 2021. In comparison to the existing Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and faster testing procedure1. This testing method can help reduce overall patient discomfort, particularly in sensitive individuals such as children, elderly people and/or people...
Source: Roche Investor Update - February 1, 2021 Category: Pharmaceuticals Source Type: news

REGEN-COV(TM) antibody cocktail is active against SARS-CoV-2 variants first identified in the UK and South Africa
Dear Investor, Please find attached a press release from our partner Regeneron: (Source: Roche Investor Update)
Source: Roche Investor Update - January 28, 2021 Category: Pharmaceuticals Source Type: news

Invitation to Roche ’s virtual event on key ophthalmology data presented at the Angiogenesis 2021 Meeting
We are pleased to invite investors and analysts to participate in our virtual event on Tuesday, 16 February, 2021, highlighting Roche data presented at the virtual Angiogenesis, Exudation, and Degeneration 2021 Meeting, from 12th to 13th February. (Source: Roche Investor Update)
Source: Roche Investor Update - January 27, 2021 Category: Pharmaceuticals Source Type: news

Regeneron reports positive interim data with REGEN-COV(TM) antibody cocktail used as passive vaccine to prevent COVID-19
Dear Investor, Please find attached a press release from our partner Regeneron:https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-positive-interim-data-regen-covtm-antibodyDo not hesitate to contact us for any further questions. With best regards, (Source: Roche Investor Update)
Source: Roche Investor Update - January 26, 2021 Category: Pharmaceuticals Source Type: news

Roche renews partnership with Sysmex to deliver haematology testing solutions
Basel, 25 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that, on 14 December, 2020, it signed a Global Business Partnership Agreement* (GBP) with Sysmex. Under this new framework, the parties renewed their commitment to the long standing Distribution, Sales and Service (DSS) agreement, allowing Roche to continue to distribute Sysmex haematology products, including instruments and reagents.2 This GBP sees the introduction of an IT Solutions Collaboration Agreement. In the newly defined collaboration, the two companies have agreed to utilise their respective IT platforms to improve customer experience, in...
Source: Roche Investor Update - January 25, 2021 Category: Pharmaceuticals Source Type: news

Roche ’s faricimab meets primary endpoint in two global phase III studies and shows potential to extend time between treatments up to 16 weeks for people with neovascular age-related macular degeneration
Basel, 25 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two identically designed global phase III studies, TENAYA and LUCERNE, evaluating its investigational bispecific antibody, faricimab, in people living with neovascular or “wet” age-related macular degeneration (nAMD). Both studies met their primary endpoint and showed that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were non-inferior to those receiving aflibercept injections every eight wee ks. Nearly half (45%) of people in both stud...
Source: Roche Investor Update - January 25, 2021 Category: Pharmaceuticals Source Type: news

FDA grants priority review to Roche ’s Esbriet (pirfenidone) for unclassifiable interstitial lung disease
Basel, 21 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet® (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD). The FDA is expected to make a decision on approval by May 2021.“Since its US approval, Esbriet has become a standard of care for people living with idiopathic pulmonary fibrosis. However, significant unmet need remains in fibrotic lung diseases, including unclassifiable interstitial lung disease ...
Source: Roche Investor Update - January 21, 2021 Category: Pharmaceuticals Source Type: news

Roche Annual General Meeting 2021: Exercising of shareholder rights via the independent proxy
Basel, 18 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that unfortunately it will not be possible for shareholders to attend the Annual General Meeting in person owing to the ongoing pandemic. Our main concern is to protect our shareholders from any potential health risks that may arise because of the ongoing difficult pandemic situation. As a precautionary and prudent measure, the Board of Directors has decided to conduct the Annual General Meeting of Roche Holding Ltd on Tuesday, 16 March 2021, in accordance with Art. 8 of the Federal Act on the Statutory Principles for Federal Council Ordinances on ...
Source: Roche Investor Update - January 18, 2021 Category: Pharmaceuticals Source Type: news

Roche confirms US government agreement to purchase additional doses of Regeneron ’s casirivimab and imdevimab
Basel, 12 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of Regeneron ’s casirivimab and imdevimab antibody cocktail for use in non-hospitalised COVID-19 patients as part of Operation Warp Speed. The US government said it will provide these additional doses at no cost to patients, though healthcare facilities may charge fees related to administration, and will conti nue to coordinate allocation of the antibody cocktail to state and territorial health departments. Under the...
Source: Roche Investor Update - January 12, 2021 Category: Pharmaceuticals Source Type: news

Roche to present updated data confirming Tecentriq in combination with Avastin substantially improves overall survival in people with the most common form of liver cancer
Basel, 12 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will present updated overall survival (OS) data from the Phase III IMbrave150 study evaluating Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab), compared with sorafenib, in people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. (Source: Roche Investor Update)
Source: Roche Investor Update - January 12, 2021 Category: Pharmaceuticals Source Type: news

Save the date: Roche Diagnostics Investor Day 2021 - Tuesday 23rd March 2021
The Roche Investor Relations team would like to invite you to the Roche Diagnostics Investor Day 2021: “Innovating diagnostics, shaping healthcare, changing lives”. (Source: Roche Investor Update)
Source: Roche Investor Update - January 11, 2021 Category: Pharmaceuticals Source Type: news