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

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 Media News - 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 Media News - 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 Media News)
Source: Roche Media News - January 12, 2021 Category: Pharmaceuticals Source Type: news

Roche launches two digital pathology image analysis algorithms for precision patient diagnosis in breast cancer
Basel, 11 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the CE-IVD launch of its automated digital pathology algorithms, uPath HER2 (4B5) image analysis and uPath Dual ISH image analysis for breast cancer to help determine the best treatment strategy for each patient. The image analysis algorithms use artificial intelligence to support pathologists in making faster, more accurate patient diagnoses in breast cancer. (Source: Roche Media News)
Source: Roche Media News - January 11, 2021 Category: Pharmaceuticals Source Type: news

Roche ’s Xofluza approved by the European Commission for the treatment of influenza, the first new influenza antiviral for patients in almost 20 years
Basel, 11 January 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved Xofluza® (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 years and above. In addition, the EC has approved Xofluza for post-exposure prophylaxis of influenza i n individuals aged 12 years and above. Post-exposure prophylaxis aims to prevent influenza in individuals following contact with someone infected with the influenza virus. The Commission’s Decision follows the positive opinion received from the European Medicines Agency’s Committee for ...
Source: Roche Media News - January 11, 2021 Category: Pharmaceuticals Source Type: news

Roche ’s novel anti-TIGIT tiragolumab granted FDA Breakthrough Therapy Designation in combination with Tecentriq for PD-L1-high non-small cell lung cancer
Basel, 5 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA), in combination with Tecentriq ® (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression with no EGFR or ALK genomic tumour aberrations. Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the FDA, and the designation is bas ed on randomised data from the phase II CITYS...
Source: Roche Media News - January 5, 2021 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for people with HER2-positive breast cancer
Basel, 23 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection for the treatment of early and metastatic HER2-positive breast cancer.“This approval represents a significant step forward in the treatment of HER2-positive breast cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The innovation of Phesgo...
Source: Roche Media News - December 23, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s faricimab meets primary endpoint and shows strong durability across two global phase III studies for diabetic macular edema, a leading cause of blindness
Basel, 21 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two identically designed global phase III studies, YOSEMITE and RHINE, evaluating its investigational bispecific antibody, faricimab, in people living with diabetic macular edema (DME). Both studies met their primary endpoint and showed that faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks. Faricimab was generally well-tolerated, with no new safety signals identified. The studies each h...
Source: Roche Media News - December 21, 2020 Category: Pharmaceuticals Source Type: news

Roche launches cobas PIK3CA Mutation Test for patients with advanced or metastatic breast cancer in countries accepting the CE mark
Basel, 15 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the cobas ® PIK3CA Mutation Test for patients with advanced or metastatic breast cancer. Previously only available as research use only (RUO), this in vitro diagnostic (IVD) test is now available in countries accepting the CE mark.“Nearly two million women are diagnosed with breast cancer each year, and an estimated half a million could harbour a PIK3CA mutation.3,4 If correctly identified, some of these women may benefit from targeted therapy, ” said Thomas Schinecker, CEO Roche Diagnostics. “We are pleased to ...
Source: Roche Media News - December 15, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s OCREVUS® (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis
Basel, 14 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for OCREVUS ® (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). The approval was based on data from the randomised, double-blind ENSEMBLE PLUS study.“More than 170,000 people with MS have been treated with OCREVUS - the only approved B-cell therapy with a twice-yearly dosing schedule - and it is the most prescribed...
Source: Roche Media News - December 14, 2020 Category: Pharmaceuticals Source Type: news

Roche launches laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
Basel, 11 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has launched a high-throughput SARS-CoV-2 antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections, in markets accepting the CE Mark. Roche has also filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration. (Source: Roche Media News)
Source: Roche Media News - December 11, 2020 Category: Pharmaceuticals Source Type: news

Roche presents exploratory data from the Phase III IMvigor010 study in early bladder cancer at the ESMO Immuno-Oncology Virtual Congress 2020
Basel, 10 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented an exploratory analysis from the Phase III IMvigor010 study evaluating Tecentriq ® (atezolizumab), compared with observation, as an adjuvant (after surgery) monotherapy treatment for people with muscle-invasive urothelial cancer (MIUC) at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Virtual Congress, 9–12 December 2020. (Source: Roche Media News)
Source: Roche Media News - December 10, 2020 Category: Pharmaceuticals Source Type: news

Roche partners with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials
Basel, 9 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced a partnership with Moderna Inc. to utilise the Elecsys ® Anti-SARS-CoV-2 S antibody test in Moderna’s mRNA-1273 vaccine research trials. This will facilitate the quantitative measurement of SARS-CoV-2 antibodies and help to establish a correlation between vaccine-induced protection and levels of anti-receptor binding domain (RBD) antibodies. Signific antly, Moderna’s vaccine triggers antibody response specifically to the RBD of the SARS-CoV-2 spike protein. This follows the recent announcement that Roche has received Emergency Use A...
Source: Roche Media News - December 9, 2020 Category: Pharmaceuticals Source Type: news

Roche presents new data from its bispecific antibody portfolio across a range of blood cancers
Roche today announced that new data on its investigational T-cell engaging bispecific antibodies, mosunetuzumab, glofitamab and cevostamab, were presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, from 5-8 December 2020, showing encouraging activity across multiple types of blood cancer. (Source: Roche Media News)
Source: Roche Media News - December 8, 2020 Category: Pharmaceuticals Source Type: news

New data presented at ASH 2020 reinforces the benefit/risk profile of fixed-duration Polivy plus bendamustine and MabThera/Rituxan in patients with relapsed or refractory diffuse large B-cell lymphoma
Basel, 07 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced longer-term data from the pivotal phase Ib/II GO29365 study, including data from a single-arm extension cohort of 106 additional patients, which show the benefit of Polivy ® (polatuzumab vedotin) plus bendamustine and MabThera®/Rituxan® (rituximab) (BR) in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not eligible for stem cell transplant. Updated data from the randomised cohort (n=80) show that with longer follow-up (48.9 months) a complete response (CR) rate of 42.5% (n=17/40) was maintained ...
Source: Roche Media News - December 7, 2020 Category: Pharmaceuticals Source Type: news

New follow-up phase III data reinforce the long-term benefit of Roche ’s Hemlibra for people with haemophilia A
Basel, 7 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from a new analysis of pooled, three-year follow-up data of 401 people with haemophilia A from the pivotal HAVEN 1-4 studies, which reinforce the long-term efficacy and safety profile of Hemlibra ® (emicizumab).[1]These data, from adults, adolescents and children with haemophilia A with and without factor VIII inhibitors, were presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 5-8 December 2020.“The long-term benefit of Hemlibra, with a consistent safety profile and durably effect...
Source: Roche Media News - December 7, 2020 Category: Pharmaceuticals Source Type: news

Roche announces new data reinforcing the long-term benefit of Venclexta/Venclyxto-based combination for people with relapsed or refractory chronic lymphocytic leukaemia
             Basel, 5 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from the pivotal phase III MURANO and CLL14 studies support the efficacy of fixed-duration, chemotherapy-free Venclexta ®/Venclyxto® (venetoclax)-based combinations in certain people with chronic lymphocytic leukaemia (CLL) and provide more evidence on the potential value of minimal residual disease (MRD). Data were presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on Saturday 5 December 2020.“...
Source: Roche Media News - December 5, 2020 Category: Pharmaceuticals Source Type: news

Roche announces FDA approval of Gavreto (pralsetinib) for people with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancers
Basel, 2 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto ™ (pralsetinib) for the treatment of adult and paediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) who require systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who re quire systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). These indications were approved under the FDA’s accelerated approval...
Source: Roche Media News - December 2, 2020 Category: Pharmaceuticals Source Type: news

Roche receives FDA Emergency Use Authorization for new test to measure the level of SARS-CoV-2 antibodies
Basel, 2 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys ® Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus. The EUA in the United States follows t he launch of the Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark announced on 18 September. (Source: Roche Media News)
Source: Roche Media News - December 2, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Xolair ® (omalizumab) for adults with nasal polyps
             Basel, 01 December 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 (sBLA) for Xolair® (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.1 Nasal polyps can lead to a loss of smell and nasal congestion, and frequently co-occur with other respiratory conditions, such as allergies and asthma. With this ap...
Source: Roche Media News - December 1, 2020 Category: Pharmaceuticals Source Type: news

Roche announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person
             Basel, 24 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza ® (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis.“With today’s approval, Xofluza is now available as the first single-dos...
Source: Roche Media News - November 24, 2020 Category: Pharmaceuticals Source Type: news

Roche ranked the most sustainable healthcare company in the Dow Jones Sustainability Indices for the eleventh time
             Basel, 16 November 2020 - For the eleventh time, Roche (SIX: RO, ROG; OTCQX: RHHBY) has been recognised as the most sustainable company in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI). This is based on an in-depth analysis of economic, social and environmental performance. The DJSI family of indices serves as a benchmark for investors who integrate sustainability considerations into their portfolios. Roche has maintained its leadership through its sustainability strategy which is fully embedded in the company ’s ...
Source: Roche Media News - November 16, 2020 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Xofluza® (baloxavir marboxil) for the treatment of influenza
Basel, 13 November 2020 – 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 Xofluza® (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 years and above. I n addition, Xofluza has been recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged 12 years and above. The CHMP recommendation is based on the results of the phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies.1,2,3 A final decision...
Source: Roche Media News - November 13, 2020 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer
Basel, 13 November 2020 – 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 Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, adm inistered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European...
Source: Roche Media News - November 13, 2020 Category: Pharmaceuticals Source Type: news

Roche to present new data across 16 blood disorders at the American Society of Hematology 2020 Annual Meeting
Basel, 5 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data for its approved and investigational medicines will be presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition from 5 – 8 December 2020. Eleven Roche medicines will be featured in more than 80 abstracts, including 22 oral presentations. With studies spanning 16 blood disorders, including non-Hodgkin lymphoma (NHL), leukaemia, multiple myeloma (MM) and haemophilia A, these data highlight the strength and breadth o f Roche’s haematology portfolio and pipeline, and commitment to de...
Source: Roche Media News - November 5, 2020 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
Basel, 2 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.“Tecentriq in combination with Avastin is the first treatment to be approved in over a decade that has improved overall survival for people with previously untreated advanced or unresectable hepatocellular carcinoma,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical O...
Source: Roche Media News - November 2, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s Tecentriq in combination with Avastin approved in China for people with the most common form of liver cancer
             Basel, 29 October 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.“Today’s approval of Tecentriq in combination with Avastin for unresectable hepatocellular carcinoma means that people in China now have a cancer immunotherapy option which is changin...
Source: Roche Media News - October 29, 2020 Category: Pharmaceuticals Source Type: news

Roche announces collaboration with Atea Pharmaceuticals to develop a potential oral treatment for COVID-19 patients
Basel, 22 October 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Atea Pharmaceuticals, Inc. announced today that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute AT-527, Atea ’s investigational oral direct-acting antiviral, to people around the globe. AT-527 acts by blocking the viral RNA polymerase enzyme needed for viral replication, and is currently being studied in a Phase 2 clinical trial for hospitalised patients with moderate COVID-19. A Phase 3 clinical trial, expected to start in Q1 2021, will explore the potential use in patients outside of the hospital setting. In...
Source: Roche Media News - October 22, 2020 Category: Pharmaceuticals Source Type: news

Roche announces full FDA approval for Venclexta combinations for acute myeloid leukaemia
             Basel, 19 October 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has granted full approval of Venclexta® (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta was previously granted provisional approval in this setting under the FDA ’s accelerated approval pro...
Source: Roche Media News - October 19, 2020 Category: Pharmaceuticals Source Type: news

First nine months of the year with 1% sales growth at constant exchange rates, significant impact of COVID-19 pandemic
Group sales increase 1% at constant exchange rates and decline 5% in Swiss francs as a result of continued appreciation of the Swiss franc against most currencies (Source: Roche Media News)
Source: Roche Media News - October 15, 2020 Category: Pharmaceuticals Source Type: news

Roche to launch laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
Roche announced today that it intends to launch a high-volume SARS-CoV-2 Antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. (Source: Roche Media News)
Source: Roche Media News - October 13, 2020 Category: Pharmaceuticals Source Type: news

Roche presents new 2-year data for Evrysdi (risdiplam) in infants with Type 1 spinal muscular atrophy (SMA)
Basel, 28 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new 2-year data from Part 1 of the pivotal FIREFISH study of Evrysdi ™ (risdiplam) in infants aged 2-7 months with symptomatic Type 1 spinal muscular atrophy (SMA). The 2-year results in infants treated with the therapeutic dose of Evrysdi (17/21) showed that they continued to improve and achieve motor milestones. This exploratory analysis showed that an estimated 88% of infants were alive and required no permanent ventilation at two years. In addition, at two years, 59% (10/17 vs. 7/17 at 1-year) of infants were able to sit without support...
Source: Roche Media News - September 28, 2020 Category: Pharmaceuticals Source Type: news

Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020
Basel, 19 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq ® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.“While we have made great progress in the treatment of many forms of breast cancer, TNBC remains an aggressive and difficult-to-treat disease,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We are proud of our work to address...
Source: Roche Media News - September 19, 2020 Category: Pharmaceuticals Source Type: news

Roche receives positive CHMP opinion for Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
Basel, 18 September 2020 - 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) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemi c therapy. Based on this recommendation, a final decision regarding approval of Tecentriq in combination with Avastin in this disease setting, along with the full details of the approved indication, is expe...
Source: Roche Media News - September 18, 2020 Category: Pharmaceuticals Source Type: news

Roche launches new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines
Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of its Elecsys ® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. Roche has filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA). The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response.1 Specifically, the test targets antibodies which are directed against the ...
Source: Roche Media News - September 18, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s phase III EMPACTA study showed Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with COVID-19 associated pneumonia
Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra ®/RoActemra® (tocilizumab) plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]). The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo...
Source: Roche Media News - September 18, 2020 Category: Pharmaceuticals Source Type: news

Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020
Basel, 17 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that results from a number of studies across its broad oncology portfolio will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which will be held 19-21 September, 2020. Results include data from three phase III studies across the Tecentriq® (atezolizumab) triple-negative breast cancer (TNBC) programme. Central nervous system (CNS) efficacy data from integrated analyses of the pivotal phase II Rozlytrek® STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials will be presented in addition to re...
Source: Roche Media News - September 17, 2020 Category: Pharmaceuticals Source Type: news

Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer
Basel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the expanded use of CINtec®PLUS Cytology, the first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus (HPV). Additional information from this test supports clinical decisions about which women will benefit most from immediate follow-up. Laboratories can now use CINtecPLUS Cytology to triage positive results from the cobas ® HPV Test run on the fully integrated, automated and high-thr...
Source: Roche Media News - September 16, 2020 Category: Pharmaceuticals Source Type: news

New data further reinforce Roche ’s OCREVUS (ocrelizumab) as a highly effective treatment for people with multiple sclerosis
Basel, 11 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data that show OCREVUS® (ocrelizumab) is a highly effective treatment option for people with relapsing-remitting multiple sclerosis (RRMS) who experienced a suboptimal response to their prior disease modifying therapy (DMT). Subgroup analys is from the two-year open-label Phase IIIb CASTING study also demonstrates that patients benefit across a wide range of disease related and demographic subgroups, regardless of prior treatment background. Findings will be presented at MSVirtual2020, the 8th Joint Meeting of the Americas Committee...
Source: Roche Media News - September 11, 2020 Category: Pharmaceuticals Source Type: news

New data show Roche ’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD)
Basel, 10 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new ENSPRYNG ® (satralizumab) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system. These data are being presented at MSVirtual2020, the 8th joint ACTRIMS-ECTRIMS meeting, in addition to longer-term efficacy data supporting the continued effect of ENSPRYNG on reducing the risk of NMOSD relapse, as well as its favourable benefit:risk profile.“The data for ENSPRYNG at MSVirtual2020 are promising and suggest it significantly reduces relapse severity ...
Source: Roche Media News - September 10, 2020 Category: Pharmaceuticals Source Type: news