Roche Holding AG

Roche Holding AG is a research healthcare company. It operates through the Roche Pharmaceuticals and Diagnostics segments. The Roche Pharmaceutical division comprises the business segments, such as Roche Pharmaceuticals and Chuga. The Diagnostic division consists of the following four business areas: centralized and point of care solutions, molecular diagnostics, tissue diagnostics and diabetes care. The company was founded by Fritz Hoffmann-La Roche on October 1, 1896 and is headquartered in Basel, Switzerland.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that Venclexta® (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the revised International Prognostic Scoring System (IPSS-R).

FDA Grants Breakthrough Therapy Designation for Venclexta in Combination With Azacitidine for the Treatment of Patients With Myelodysplastic Syndromes

Basel, 20 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve™(casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act.

Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

According to Roche Holding AG's (OTC: RHHBY) Genentech division, new data from a phase 3b study reinforces the safety profile of blockbuster hemophilia A treatment Hemlibra. The new safety data from the Phase 3b STASEY study revealed that Hemlibra was effective with no new safety signals identified in adults and adolescents with hemophilia A with factor VIII inhibitors.

Roche Unveils New Hemlibra Data Reinforcing Safety Profile In Hemophilia A

Basel, 19 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the final analysis of the phase IIIb STASEY study, which confirm the favourable safety profile of Hemlibra® (emicizumab), consistent with the phase III HAVEN clinical programme.1,2,3,4 In the analysis, no new safety signals were identified with longer-term Hemlibra treatment in adults and adolescents with haemophilia A with inhibitors to factor VIII, the clotting protein that is missing or defective in people with haemophilia A. The data were presented at the virtual International Society on Thrombosis and Haemostasis (ISTH) 2021 Congress, 17-21 July 2021.

New data for Roche's Hemlibra reinforce safety profile in people with haemophilia A

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from the final analysis of the Phase IIIb STASEY study, which confirm the favorable safety profile of Hemlibra® (emicizumab-kxwh), consistent with the Phase III HAVEN clinical program. In the analysis, no new safety signals were identified with longer-term Hemlibra treatment in adults and adolescents with hemophilia A with inhibitors to factor VIII, the clot

New Data for Genentech's Hemlibra (emicizumab-kxwh) Reinforce Safety Profile in People With Hemophilia A

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Despite easing restrictions, COVID is going to be around a lot longer than many think.

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Several drugmakers have important clinical trial updates on the way.

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Basel, 09 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the cobas® MTB and cobas® MTB-RIF/INH tests for use on the cobas® 6800/8800 Systems are included as part of the updated World Health Organization (WHO) policy guidelines on nucleic acid amplification tests (NAATs) to detect tuberculosis (TB) and drug-resistant TB. The new guidance expands the number of rapid molecular tests available to national TB programmes in high-burden countries, enabling multi-partner diagnostic approaches that can benefit patients and communities.

WHO guidelines now include Roche's diagnostic tests in expanded effort to eliminate tuberculosis by providing patients greater access to timely diagnosis

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The latest guideline update by the WHO includes the use of arthritis drugs like Roche's (RHHBY) Actemra and Sanofi's (SNY) Kevzara for the treatment of severe COVID-19.

WHO Guidelines Put Spotlight on Arthritis Drugs Actemra & Kevzara

The World Health Organization (WHO) has endorsed Interleukin-6 (IL-6) receptor antagonists combined with corticosteroids to treat severe COVID-19 cases. Patients severely or critically ill with COVID-19 often suffer from an overreaction of the immune system.

WHO Recommends IL-6 Drugs From Sanofi, Roche For Critically-Ill COVID-19 Patients

The World Health Organization began recommending the use of medicines called interleukin-6 receptor blockers as COVID-19 treatments for the severely ill, based on the findings of a large clinical study published Tuesday in JAMA. Roche Holding AG's Actemra and Sanofi and Regeneron Pharmaceuticals Inc.'s Kevzara are both approved in the U.S. as treatments for rheumatoid arthritis.

WHO recommends Roche, Sanofi/Regeneron drugs as COVID-19 treatments, calls for lower prices

Basel, 02 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its haemophilia A clinical programme will be presented at the virtual International Society on Thrombosis and Haemostasis (ISTH) 2021 Congress, from 17-21 July 2021. Data will include the final analysis from the phase IIIb STASEY study of Hemlibra® (emicizumab) and updated data from the phase I/II study of SPK-8011, an AAV-based gene therapy in development by Spark Therapeutics (a member of the Roche Group).1,2

Roche to present new data at the ISTH 2021 Congress highlighting long-standing commitment to advancing haemophilia A standard of care

Roche plans to cut 300-400 jobs this year at product development (PD) sites, company executives including Chief Medical Officer Levi Garraway said during a recorded video call with employees obtained by Swiss newspaper Blick.

Roche to cut 300-400 product development jobs - Blick

Novartis wants Roche to return $210 million after accusing its Swiss rival of inappropriately pocketing fees from a 16-year-old patent licensing agreement, according to a U.S. District Court lawsuit.

Novartis fights Roche in $210 million U.S. dispute over licensing fees

As the S&P 500 notches record highs, veteran investor David Roche says investors should be wary of the bubble bursting.

Top investment strategist David Roche warns the Fed could burst a market 'bubble'

The FDA issues an Emergency Use Authorization for Roche's (RHHBY) Actemra for the treatment of COVID-19 in hospitalized adults and pediatric patients.

Roche's (RHHBY) Actemra Gets FDA Emergency Nod for COVID-19

The European Commission has approved Roche Holding AG's (OTC: RHHBY) injectable Enspryng for adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD). The approval for the treatment comes as a monotherapy or in combination with immunosuppressive therapy.

Roche's Enspryng Wins European Approval For Spinal Cord, Optic Nerve Inflammation Disorder

Basel, 28 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has approved ENSPRYNG® (satralizumab) for the treatment of adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). ENSPRYNG is the first and only NMOSD treatment that is administered subcutaneously every four weeks, allowing home-dosing after appropriate training. “An NMOSD relapse can be devastating, causing permanent neurological damage and disability that accumulates with subsequent relapses, which is why our goal is to prevent them,” said Prof. Dr. Friedemann Paul, Professor of Clinical Neuroimmunology, Charité Universitätsmedizin Berlin. “With the approval of ENSPRYNG, we now have a treatment option with a favourable safety profile that significantly reduces relapses in AQP4-IgG seropositive adults and adolescents after their first NMOSD attack or in more advanced disease, either as a monotherapy or in combination with IST. Importantly, people with NMOSD now have the flexibility to administer treatment at home, which may alleviate the need to travel for hospital appointments.” The EC approval is supported by results from two Phase III studies, in which ENSPRYNG showed robust and sustained efficacy in reducing the risk of relapse in people with AQP4-IgG seropositive NMOSD. AQP4-IgG are present in around 70-80% of people with NMOSD, who tend to experience a more severe disease course compared to those not expressing AQP4-IgG antibodies. “We thank the NMOSD community for their partnership and are delighted that ENSPRYNG will be available to people in the EU who until now had limited, accessible treatment options,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “Building on our growing scientific understanding of neuroimmunological conditions, we are confident ENSPRYNG can transform how people with NMOSD are treated by fitting into their day-to-day lives.” ENSPRYNG is the first and only approved medicine for NMOSD in the EU designed to bind to and block the interleukin-6 (IL-6) receptor, a central driver of the inflammation associated with NMOSD. The treatment was designed by Chugai, a member of the Roche Group, using novel recycling antibody technology. When compared to conventional antibodies, ENSPRYNG's recycling antibody technology enables the medicine to remain in the bloodstream for a longer period of time and bind repeatedly to its target (the IL-6 receptor) – maximally sustaining IL-6 suppression in a chronic disease like NMOSD and enabling subcutaneous dosing every four weeks. Roche is working closely with reimbursement and health technology assessment bodies in EU member states to provide access to ENSPRYNG for people who may benefit from this treatment option as soon as possible. About SAkuraStar and SAkuraSky in NMOSD ENSPRYNG has been investigated in two pivotal Phase III studies in neuromyelitis optica spectrum disorder (NMOSD), with the primary endpoint of both studies being time to first protocol-defined relapse (PDR) adjudicated by an independent review committee in the double-blind period. The Phase III SAkuraStar study evaluated the efficacy and safety of ENSPRYNG monotherapy administered to adults with NMOSD. In the anti-aquaporin-4 antibody (AQP4-IgG) seropositive subgroup, 83% treated with ENSPRYNG remained relapse free at 48 weeks, compared with 55% of those treated with placebo. At 96 weeks, 77% of those treated with ENSPRYNG remained relapse free, compared with 41% with placebo. The Phase III SAkuraSky study evaluated the efficacy and safety of ENSPRYNG in combination with baseline immunosuppressive therapy in adults and adolescents with NMOSD. Overall, 92% of AQP4-IgG seropositive participants receiving ENSPRYNG in combination with IST remained relapse free at 48 and 96 weeks, compared with 60% and 53% with placebo, respectively. ENSPRYNG showed a favourable safety and tolerability profile in the Phase III studies. The most common adverse reactions observed in the safety population were: headache, arthralgia, white blood cell count decrease, hyperlipidaemia and injection-related reactions. About neuromyelitis optica spectrum disorder (NMOSD ) NMOSD is a rare, lifelong and debilitating autoimmune condition of the central nervous system that primarily damages the optic nerve(s) and spinal cord, causing permanent blindness, muscle weakness and paralysis. People with NMOSD experience unpredictable, severe relapses directly causing cumulative, permanent, neurological damage and disability. In some cases, relapse can result in death. NMOSD affects over 10,000 people in Europe, up to 15,000 people in the US and approximately 200,000 people worldwide. NMOSD can affect individuals of any age, race and gender, but is most common among women in their 30s and 40s, and appears to occur at higher rates in people of African or Asian background. NMOSD is commonly associated with pathogenic antibodies (AQP4-IgG) that target and damage a specific cell type, called astrocytes, resulting in inflammatory lesions of the optic nerve(s), spinal cord and brain. AQP4-IgG antibodies are detectable in the blood serum of around 70-80% of people with NMOSD. Although most cases of NMOSD can be confirmed through diagnostic tests, people living with the condition are still frequently misdiagnosed with multiple sclerosis. This is due to overlapping characteristics of the two disorders, including a higher prevalence in women, similar symptoms and the fact that people can experience relapses in both conditions. About ENSPRYNG® ( satralizumab ) ENSPRYNG, which was designed by Chugai, a member of the Roche Group, is a humanised monoclonal antibody that targets interleukin-6 (IL-6) receptor activity. The cytokine IL-6 is believed to be a key driver in NMOSD disease processes, triggering the inflammation cascade and leading to damage and disability. ENSPRYNG was designed using novel recycling antibody technology. When compared to conventional antibodies, ENSPRYNG's recycling antibody technology enables the medicine to remain in the bloodstream for a longer period of time and bind repeatedly to its target (the IL-6 receptor) - maximally sustaining IL-6 suppression in a chronic disease like NMOSD and enabling subcutaneous dosing every four weeks. Positive Phase III results for ENSPRYNG, as both monotherapy and in combination with baseline immunosuppressive therapy, suggest that IL-6 inhibition is an effective therapeutic approach for NMOSD. The Phase III clinical development programme for ENSPRYNG included two studies: SAkuraStar and SAkuraSky. ENSPRYNG is currently approved in 54 countries, including the United States, Canada, Japan, China and EMA territory countries. ENSPRYNG has been designated as an orphan drug in the U.S., Europe and Japan. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018, which is given to treatments that may demonstrate substantial improvement over other available options. About Roche in neuroscience Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases. Roche is investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, Alzheimer's disease, Huntington's disease, Parkinson's disease, Duchenne muscular dystrophy and autism spectrum disorder. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.All trademarks used or mentioned in this release are protected by law. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Roche's ENSPRYNG approved by European Commission as first and only at-home subcutaneous treatment for neuromyelitis optica spectrum disorder (NMOSD)

Shares of Roche Holding Group were up 0.1% in trading on Friday, the day after the company said its COVID-19 drug has been authorized in the U.S. as a treatment for those who have been hospitalized with COVID-19 who are at least two years old. The drug, Actemra, is already approved by the Food and Drug Administration as a treatment for rheumatoid arthritis.

Roche's arthritis drug gets authorized as COVID-19 treatment for the severely ill

The FDA has approved Roche Holding AG's (OTC:RHHBY) arthritis drug Actemra (tocilizumab) for emergency use to treat adults and pediatric patients hospitalized with COVID-19. It was already allowed to be administered on compassionate grounds.

FDA Gives Emergency Use Nod For Roche's Arthritis Drug Against Severe COVID-19

Basel, 25 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra/RoActemra® (tocilizumab) for the treatment of COVID-19 in hospitalised adults and paediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The EUA is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients. The results of these studies suggest that Actemra/RoActemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.

Roche's Actemra/RoActemra receives U.S. FDA Emergency Use Authorization for the treatment of COVID-19 in hospitalised adults and children

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra® (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or e

Genentech's Actemra Receives FDA Emergency Use Authorization for the Treatment of COVID-19 In Hospitalized Adults and Children

The FDA accepts and grants Priority Review to Roche's (RHHBY) application for Port Delivery System with ranibizumab for the treatment of nAMD.

Roche's (RHHBY) BLA for PDS With Ranibizumab Accepted by FDA

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 approximately 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 injections of anti-vascular endothelial growth factor (VEGF), the current standard of care.4 The FDA is expected to make a decision on approval by 23 October 2021.

FDA accepts application for Roche's Port Delivery System with ranibizumab (PDS) for treatment of neovascular or “wet” age-related macular degeneration (nAMD)

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (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 wet, or neovascular, age-related macular degeneration (AMD). Wet AMD is a leading cause of blindness for people aged 60 and over and impacts approximately 1.1 mill

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