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

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 Media News - 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 Media News - 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 Media News)
Source: Roche Media News - 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 Media News - 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 Media News - 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 Media News - 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 Media News)
Source: Roche Media News - 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 Media News - 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 Media News)
Source: Roche Media News - March 11, 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 Media News - 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 Media News - 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 Media News)
Source: Roche Media News - 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 Media News)
Source: Roche Media News - 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 Media News - February 26, 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 Media News - February 25, 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 Media News - February 12, 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 Media News)
Source: Roche Media News - 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 Media News - 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 Media News - February 1, 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 Media News - 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 Media News - January 25, 2021 Category: Pharmaceuticals Source Type: news