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.

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.

Roche provides update on the phase III REMDACTA trial of Actemra/RoActemra plus Veklury in patients with severe COVID-19 pneumonia

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the global Phase III randomized, double-blind, multicenter REMDACTA study of Actemra® (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 ide

Genentech Provides Update on the Phase III REMDACTA Trial of Actemra Plus Veklury in Patients With Severe COVID-19 Pneumonia

AbbVie

Top-selling drugs from AbbVie Inc.(NYSE:ABBV) and Roche (RHHBY) head the list of medications that will lose patent protection this year. How the losses affect the companies' bottom lines—and perhaps their share price—will depend on how fast generic competitors encroach on their market share, how well other products fill any gaps and the success companies have in protecting their brand name drugs via creative methods.

AbbVie and Roche Will be Hardest Hit by Patent Expirations

Pfizer

The FDA has approved Roche Holdings AG's (OTCMKT: RHHBY) Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer patients eligible for treatment with Pfizer Inc's (NYSE: PFE) Lorbrena (lorlatinib). The assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded non-small cell lung cancer tissue.

FDA Ok's Roche's Companion Diagnostic For Pfizer's Lorbrena In Lung Cancer

TUCSON, Ariz., March 9, 2021 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced US Food and Drug Administration (FDA) approval of the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for...

Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for targeted treatment with LORBRENA (lorlatinib)

Roche (RHHBY) voluntarily withdraws the bladder cancer indication of Tecentriq in the United States.

Roche (RHHBY) Withdraws Bladder Cancer Indication for Tecentriq

Roche Holding AG (OTCMKT: RHHBF) has joined AstraZeneca Plc (NASDAQ: AZN) in withdrawing cancer immunotherapies from the U.S. for bladder cancer that has already been treated with platinum-based chemotherapy, as confirmatory trials not meet their primary endpoints. The company decided to withdraw the U.S. indication for Tecentriq (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer).

Roche Walks Away From Regular FDA Nod For Tecentriq In Pretreated Bladder Cancer

Basel, 8 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the company is voluntarily withdrawing the US indication for Tecentriq® (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer). This decision was made in consultation with the US Food and Drug Administration (FDA) as part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. Roche will work with the FDA over the coming weeks to complete the withdrawal process. This decision does not affect other approved indications for Tecentriq. Roche is notifying healthcare professionals about this withdrawal. Patients being treated with Tecentriq for prior-platinum treated mUC should discuss their care with their healthcare provider. “The Accelerated Approval Program allows people with difficult-to-treat cancers to receive certain new therapies earlier,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “While the withdrawal of Tecentriq for prior-platinum treated bladder cancer is disappointing, Tecentriq continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients.” The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, with specific post marketing requirements (PMRs) to confirm the clinical benefit and convert to regular approval. Tecentriq was granted accelerated approval in 2016 for the treatment of prior-platinum treated mUC based on the results from the IMvigor210 study (Cohort 2). Continued approval for this indication was contingent upon the results of IMvigor211, the original PMR for the prior-platinum treated mUC indication. 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 cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person's immune system combats cancer more effectively. Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell lung cancer, small cell lung cancer, certain types of mUC, in PD-L1-positive mTNBC and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma. About Roche in cancer immunotherapy Roche's rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time. In addition to Roche's approved PD-L1 checkpoint inhibitor, Tecentriq® (atezolizumab), Roche's broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies. To learn more about Roche's scientific-led approach to cancer immunotherapy, please follow this link: http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm 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 under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. 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. 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 provides update on Tecentriq US indication in prior-platinum treated metastatic bladder cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company is voluntarily withdrawing the U.S. indication for Tecentriq® (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer). This decision was made in consultation with the U.S. Food and Drug Administration (FDA) as part of an industry-wide review of accelerated approvals with confirmatory trials that have not met th

Genentech Provides Update on Tecentriq U.S. Indication in Prior-Platinum Treated Metastatic Bladder Cancer

The FDA has approved Roche Holdings AG's (OTCQX: RHHBY) Actemra/RoActemra (tocilizumab) for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Systemic sclerosis, also known as scleroderma, is an autoimmune disease causing tissues of the skin and lungs to thicken and harden.

Roche's Tocilizumab Injection Wins FDA Approval For Lung Disease

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 cure. It occurs when the immune system malfunctions causing tissues of the skin and lungs to thicken and harden.1-3 SSc affects about 2.5 million people worldwide.4 Interstitial lung disease (ILD), which may occur in approximately 80% of SSc patients, causes inflammation and scarring of the lungs and can be life-threatening.5

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

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) approved Actemra® (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 is the first biologic therapy approved by the FDA for t

Genentech's Actemra 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, 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.

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) 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.

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) 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 living with this condition. The CHMP recommendation was completed under the accelerated assessment pathway, which is offered to medicines deemed to be of major interest for public health and therapeutic innovation. A final decision regarding approval is expected from the European Commission in the next two months and will be applicable to all 27 European Union member states, as well as Iceland, Norway, and Liechtenstein. Evrysdi was approved by the U.S. Food and Drug Administration (FDA) in August 2020. “Our close partnership with the SMA community has enabled the development of the first ‘at-home' treatment for SMA in infants, children and adults with varying levels of disease severity, the majority of whom remain untreated,” said Levi Garraway, M.D., Ph. D., Roche's Chief Medical Officer and Head of Global Product Development. “If approved, Evrysdi would represent a much-needed therapeutic option and we expect it to become the treatment of choice for people living with SMA and their families." The CHMP recommendation is based on data from two clinical studies designed to represent a broad spectrum of people living with SMA: FIREFISH in symptomatic Type 1 infants aged 2 to 7 months and SUNFISH in symptomatic Type 2 and 3 children and adults aged 2 to 25 years. SUNFISH is the first and only placebo-controlled trial to include adults with Types 2 and 3 SMA. In FIREFISH, 29% (12/41; p

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

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Roche Holding AG (OTCMKTS: RHHBY) has reported positive data from the dose-finding Part 1 FIREFISH Phase 2/3 study of Evrysdi (risdiplam) in infants with symptomatic Type 1 spinal muscular atrophy (SMA). Evrysdi helps in the survival of motor neuron 2 (SMN2) splicing modifier designed for treating SMA by boosting SMN protein production.

Roche Reports Positive Evrysdi Data From Dose-Finding Part Of Spinal Muscular Atrophy Trial

SAN FRANCISCO--(BUSINESS WIRE)--UCSF, UC Berkeley announce partnership with Genentech to speed development of therapeutics for brain diseases and CNS disorders such as Alzheimer's.

Weill Neurohub Joins Forces With Genentech and Roche to Advance Neuroscience Research

Spark Therapeutics

PHILADELPHIA, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Spark Therapeutics, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and a fully integrated, commercial gene therapy company dedicated to challenging the inevitability of genetic disease, today announced the appointment of Cynthia Pussinen as chief technical officer (CTO). Cynthia has more than 25 years of experience in the biopharma industry, leading teams in manufacturing, quality, supply chain, formulation development and process sciences. As CTO, she will oversee Spark's manufacturing and technical operations, including pipeline process development, preclinical and clinical manufacturing, and the commercial manufacturing and distribution of LUXTURNA® (voretigene neparvovec-rzyl).

Spark Therapeutics Further Strengthens Technical Expertise with Appointment of Cynthia Pussinen as Chief Technical Officer

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 without 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 motor neuron (SMN) protein by a median 1.9-fold from baseline in the high-dose cohort at 12 months.

Roche announces results from Evrysdi (risdiplam) study in infants with Type 1 spinal muscular atrophy (SMA) published in New England Journal of Medicine

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that Evrysdi™ (risdiplam) data from the dose finding Part 1 of the pivotal FIREFISH study in infants with symptomatic Type 1 spinal muscular atrophy (SMA) were published in the February 24, 2021 online issue of the New England Journal of Medicine (NEJM). The data show that treatment with Evrysdi at 12 months helped 90% (19/21) of these infants survive without perman

Genentech Announces Results From Evrysdi (risdiplam) Study in Infants With Type 1 Spinal Muscular Atrophy (SMA) Published in New England Journal of Medicine

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Roche Holding's (OCTMKT: RHHBY) bispecific antibody faricimab has matched Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) blockbuster drug, Eylea (aflibercept), in four Phase 3 studies, comparing the two in diabetic macular edema (DME) and wet age-related macular degeneration (AMD). New data from the studies showed that faricimab, which targets VEGF and Ang2, given at intervals of up to four months, offered non-inferior vision gains compared to aflibercept, given every two months.

News for Roche Holding AG Stock (RHHBY)