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.

SEI Investments

T. Rowe Price Group

The 3 Safest Dividend Blue-Chips To Help You Sleep Well At Night

Regeneron Pharmaceuticals

Roche Holdings AG (OTCMKTS: RHHBY) has received Emergency Use Authorization in India for its investigational antibody cocktail (casirivimab and imdevimab) for treatment of COVID-19. Cipla will partner for pan-India distribution.

India Gives Emergency Use Nod To Roche-Regeneron's COVID-19 Antibody Cocktail

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 receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.

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

Hanover Insurance Group

The Hanover Insurance Group, Inc. (THG) CEO Jack Roche on Q1 2021 Results - Earnings Call Transcript

Merck

The FDA's Oncologic Drugs Advisory Committee voted 5-3 in favor of keeping Merck & Co's (NYSE: MRK) Keytruda (pembrolizumab) accelerated approval alive as a first-line bladder cancer treatment, even after a Merck confirmatory trial failed. While the confirmatory trial did not show a benefit for Keytruda as a first-line treatment, much of the discussion centered on these subgroups of patients who might have no treatment options without Keytruda.

Oncologic Drugs Adcomm Backs Merck's Keytruda, Roche's Tecentriq Accelerated Approvals In Bladder Cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favor of maintaining accelerated approval of Tecentriq® (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express hig

FDA Advisory Committee Votes in Favor of Maintaining Accelerated Approval of Genentech'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 urothelial 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 any platinum-containing chemotherapy regardless of PD-L1 status. Today's ODAC meeting is 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. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche's Tecentriq for previously untreated metastatic bladder cancer

The FDA kicked off a three-day meet to reexamine the accelerated approvals of immuno-oncology drugs with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. FDA's Oncologic Drugs Advisory Committee (ODAC) started the meet with Roche Holdings AG's (OTCMKTS: RHHBY) Tecentriq, a PD-L1 inhibitor.

FDA Oncology Adcomm Votes To Keep Conditional Approval For Roche's Tecentriq In Place For Now

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 better manage heart failure⁵ (NT-proBNP). Roche's introduction of five new intended uses for these existing, globally accepted diagnostic solutions means more people could benefit from improved cardiovascular diagnostics. By providing greater precision and certainty for clinicians, Roche can help them tackle the world's biggest killer: cardiovascular diseases. “The five new solutions we launch this month add real value for clinicians by supporting cardiac risk identification and improving diagnosis. In turn, this will help them make early treatment decisions, improve people's lives and reduce healthcare costs,” said Thomas Schinecker, CEO Roche Diagnostics. “As the market leader in cardiovascular testing Roche is committed to innovation in cardiovascular care and these new intended uses are the first of many solutions planned over the next decade that could help improve the lives of millions of people.” One of the new intended uses for Elecsys® NT-proBNP supports healthcare professionals in identifying which people with type-2 diabetes (463 million worldwide⁶) are at higher risk of developing cardiovascular disease⁷. Early identification of people at risk means cardioprotective treatment can be started sooner, which could prevent 65% of hospitalisations or deaths⁸. The second newly-launched intended use for NT-proBNP provides healthcare professionals with a biomarker-based solution that identifies people at risk of developing Atrial Fibrillation (AF), an abnormal heart rhythm that can lead to stroke, brain damage and death⁹. More than 37 million people suffer from AF globally¹⁰. NT-proBNP, in combination with a single lead (or higher) electrocardiogram, can help to successfully diagnose AF so therapy can be started to reduce the stroke risk¹¹. Another important biomarker, Elecsys® cTnT-hs, now provides healthcare professionals with data to help predict heart attack risk and mortality in non-cardiac surgery patients. Every year, over 200 million adults undergo major non-cardiac surgery with 10 million suffering from major adverse cardiac events (MACE) that could be prevented through early and accurate diagnosis¹². Both Elecsys® NT-proBNP and Elecsys® cTnT-hs can be run on all cobas e® analysers. They are among the first products certified under the new European In Vitro Diagnostics Regulation (IVDR) and available as of today in countries accepting CE mark. Availability in other countries is subject to local registration processes and timelines. About Elecsys ® NT- proBNP Tests for NT-proBNP, a cardiac hormone that is released into the blood when the heart wall is stretched, are developed and marketed by Roche. NT-proBNP is an objective marker for the aid in diagnosis in individuals suspected of having congestive heart failure and detection of mild forms of cardiac dysfunction. This assay is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure, and it can also be used for monitoring the treatment in patients with left ventricular dysfunction. Added intended uses for Elecsys ® NT- proBNP (1) Type-2 diabetes and heart failure 463 million people suffer from type-2 diabetes worldwide⁴ and are at higher risk of developing cardiovascular disease. The new intended use of Elecsys® NT-proBNP provides healthcare professionals with a precise biomarker that supports them to identify patients with high cardiovascular risk. This means that effective drug treatment can be started early so that cardioprotective treatment can be optimized. In PONTIAC-I it was shown that 65% of hospitalisations or death could be prevented⁸. (2) Atrial fibrillation More than 37 million people suffer from Atrial Fibrillation (AF) and 25% of people over 40 years old develop AF in their lifetime. More than 450 million people aged 70 or above are considered high risk for this disease. Patients with AF are exposed to a fivefold risk of stroke¹³ and therefore brain damage or death¹⁴. One of the key elements in reducing stroke is early detection of people at risk of Atrial Fibrillation by better identification methods. Our second launched intended use for Elecsys® NT-proBNP provides healthcare professionals with a biomarker based solution that identifies people at risk and, in combination with a single lead (or higher) ECG, can aid successful diagnosis so therapy can be started. About Elecsys ® cTnT-hs The Elecsys cardiac Troponin T high-sensitivity (cTnT-hs) test from Roche, detects cardiac troponin which is the guideline recommended biomarker for the diagnosis of heart attack in clinical practice. In combination with an electrocardiogram (ECG), high-sensitive Troponin has become the gold standard for the diagnosis of heart attack. Using the accelerated ESC 0/1 hour algorithm with the Elecsys cTnT-hs assay, significantly accelerates “rule-in” and “rule-out” decision-making, thereby maximising the potential for effective treatment. At the same time, the faster decision-making may help to better manage the emergency room workload and related costs for healthcare systems¹⁵. Added intended uses for Elecsys ® cTnT-hs in coronary artery disease (3) Over 200 million adults globally undergo major non-cardiac surgery every year. Of these, over 10 million suffer from major adverse cardiac events (MACE) in the first 30 days after non-cardiac surgery and more than 80% of those are clinically asymptomatic. The new intended use for Elecsys® cTnT-hs provides healthcare professionals with a biomarker that helps to predict the perioperative risk of a heart attack and to a perioperative heart attack in non-cardiac surgeries to allow clinicians to tailor surgery and post-operative care accordingly. (4) The second newly-launched intended use for Elecsys® cTnT-hs makes the biomarker serve as an aid in assessing the long-term risk of cardiovascular events (death, myocardial infarction, coronary revascularisation, heart failure or ischemic stroke) in asymptomatic individuals. (5) Elecsys® cTnT-hs is the gold standard for triaging patients suspected of Acute Coronary Syndrome in Emergency Departments and Intensive Care Units The third launched intended use for this biomarker can help to improve early discharge and outpatient management of these patients. 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. References [1] 17.9 M deaths: https://www.who.int/health-topics/cardiovascular-diseases/#tab=tab_1 [2] A third of all deaths: Mensah, G. A., et al. (2019). "The Global Burden of Cardiovascular Diseases and Risk Factors." 2020 and Beyond 74(20): 2529-2532[3] Gold standard biomarkers: Ohman EM. Clin Chem 2017; 63: 429 Gold standard biomarkers: McKie, PM., et al. (2016). J Am Coll Cardiol 68(22), 2437-2439[4] Help clinicians diagnose heart attacks (cTnT-hs): Roff M et al, Eur Heart J 2016; 37: 267Help clinicians diagnose heart attacks (cTnT-hs): Amsterdam EA et al., Circulation 2014;130:2354[5] Better manage heart failure (NT-proBNP): Ponikowski P et al., Eur Heart J 2016; 37:2129 Better manage heart failure (NT-proBNP): Yancy CW et al, Circulation. 2017;136:e137;[6] 463 million diabetics worldwide: Saeedi P et al., Diabetes Res Clin Pract 2019[7] “NT-proBNP supports healthcare professionals in identifying which type-2 diabetes patients are at a higher risk of developing cardiovascular disease”: Huelsmann M. et al. JACC. 2013, 62:1365-72[8] PONTIAC reference: 65% of hospitalisations or death: Huelsmann, M. et al., J Am Coll Cardiol., 2013; Vol. 62, pp. 1365-1372 [same as ref 9][9] Atrial Fibrillation (AF), the most common of abnormal heart rhythms which can lead to stroke, brain damage and death (ref: Hindricks, G. Eur Heart J (2020) Aug 29;ehaa612Atrial Fibrillation (AF), the most common of abnormal heart rhythms which can lead to stroke, brain damage and death (ref: January C.T., et al. Circulation (2014); 130:e199–e267)Atrial Fibrillation (AF), the most common of abnormal heart rhythms which can lead to stroke, brain damage and death(ref: January, C.T. Circulation (2019); 140(2):e125-e151)[10] More than 37 million people suffer from AF globally (ref: Lippi G. et al (2020), International Journal of Stroke. 16 (2): 217-221)[11 NT-proBNP, in combination with a single lead (or higher) electrocardiogram, can help to successfully diagnose AF so therapy can be started.(ref: Gudmundsdottir, K. et al. (2020). Eurospace 22, 24-32) [12] Every year, over 200 million adults undergo major non-cardiac surgery⁶ with 10 million suffering from major adverse cardiac events (MACE) that could be prevented through early and accurate diagnosis. (ref: Devereaux PJ, Sessler DI. (2015). Cardiac complications in patients undergoing major noncardiac surgery. N Engl J Med 373, 2258-2269) [13] Patients with AF are exposed to a fivefold risk of stroke → Patients with AF have a 5-fold increased risk of stroke. (ref: Wolf et al, Stroke Vol 22, No 8 August 1991)[14] and therefore brain damage or death → and greater frequency of brain damage, disability or death. (ref: Alkhouli, M. JACC Clin     Electrophysiol (2018); 4(5):618-625. and therefore brain damage or death → and greater frequency of brain damage, disability or death. (ref:Marini, C. Stroke (2005); 36(6):1115-1119. and therefore brain damage or death → and greater frequency of brain damage, disability or death. (ref:Hannon, N. Cerebrovasc Dis (2010); 29(1):43-49. [15] Using the accelerated ESC 0/1 hour algorithm with the Elecsys cTnT-hs assay, significantly accelerates “rule-in” and “rule-out” decision-making, thereby maximising the potential for effective treatment. At the same time, the faster decision-making may help to better manage the emergency room workload and related costs for healthcare systems. (ref: Kiril M Stoyanov et al. (2020) Acute Cardiovascular Care, 9(1): 39–51, Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Roche launches new ways to use their cardiovascular tests empowering clinicians to improve diagnosis and treatment of millions of people

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7 to 2 in favor of maintaining accelerated approval of Tecentriq ® (atezolizumab) in combination with chemotherapy (Abraxane ®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer

FDA Advisory Committee Votes in Favor of Maintaining Accelerated Approval of Genentech's Tecentriq for PD-L1-Positive, Metastatic Triple-Negative Breast Cancer

Basel, 28 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7 to 2 in favour of maintaining accelerated approval of Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumours express PD-L1, as determined by an FDA-approved test. Today's ODAC meeting is 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. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts, though the recommendations are not binding. The FDA has not announced when it will make its final decision for Tecentriq in this indication. “People with triple-negative breast cancer have few treatment options, which is why today's committee decision to recognise the importance of this Tecentriq combination is significant,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We are grateful to the FDA and ODAC for the open dialogue and look forward to continued collaboration to improve the lives of people with breast cancer.” The FDA's Accelerated Approval Program allows for conditional approval of a medicine that fills an unmet medical need for a serious condition, with specific postmarketing requirements (PMRs) to confirm the clinical benefit and convert to regular approval. Tecentriq was granted accelerated approval in March 2019 for the treatment of adults with PD-L1-positive, unresectable locally advanced or mTNBC based on the positive progression-free survival (PFS) results from the IMpassion130 study. Continued approval for this indication was contingent upon the results of IMpassion131, the PMR for the mTNBC indication. 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 approved for particularly difficult to treat cancers. Tecentriq's extensive development programme includes multiple ongoing and planned Phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings. Tomorrow, on 28 April, the ODAC will discuss Tecentriq's accelerated approval for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy. About triple-negative breast cancer Breast cancer is the most common cancer among women with more than 2 million diagnosed worldwide each year.1 TNBC represents ~15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer.2-4 It is defined by the lack of expression and/or amplification of the targetable receptors for oestrogen, progesterone and HER2 amplification.5 Patients with mTNBC generally experience rapid progression and shorter overall survival compared to other subtypes of breast cancer.3 About Roche in breast cancer Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough innovations in HER2-positive and triple negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive. Our targeted medicines Herceptin, Perjeta, Phesgo, Kadcyla and Tecentriq are continuing to transform the treatment of early and advanced HER2-positive and triple negative breast cancers and, through our clinical programmes, we hope to bring new treatment combinations to people with breast cancer, ultimately improving outcomes. 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 NSCLC, SCLC, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer 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. References [1] World Health Organization: Globocan 2020 – Breast Cancer Factsheet. [Internet; cited 15 April] Available from: https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf. [2] Yao H et al. Triple-negative breast cancer: is there a treatment on the horizon? Oncotarget. 2017;8(1):1913–1924.[3] BreastCancer.org. What is Triple-Negative Breast Cancer? [Internet; cited 15 April] Available from: https://www.breastcancer.org/symptoms/diagnosis/trip_neg?what. [4] Cancer Treatment Centers of America. Triple negative breast cancer risk factors. [Internet; cited 15 April] Available from: https://www.cancercenter.com/breast-cancer/risk-factors/tab/triple-negative-breast-cancer-risk-factors/. [5] Pal SK et al. Triple negative breast cancer: unmet medical needs. Breast Cancer Res Treat. 2011;125(3):627–636. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche's Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer

Bristol-Myers

The Food and Drug Administration advisory committee plans to hold a three-day meeting this week to evaluate a type of quicker approval used primarily for immuno-oncology drugs that are thought to help address unmet treatment needs among people with cancer. The FDA's "accelerated approval" process requires drug makers to conduct what are called confirmatory trials to back up the limited data used to inform the initial regulatory ok.

FDA to discuss whether immuno-oncology drugs with 'accelerated' approval should remain on the market

Guardant Health Inc

Their liquid biopsies are giving doctors new and better tools to spot, track, and treat cancers.

Disruptor Alert: These 2 Companies Are Changing Cancer Care

AbbVie

European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of Roche Holdings AG's (OTCMKTS: RHHBY) Enspryng, AbbVie Inc's (NYSE: ABBV) Venclyxto (venetoclax), and Bristol-Myers Squibb Co's (NYSE: BMY) Opdivo Plus Yervoy and Onureg. The final decision is expected to be delivered during the first half of 2021.

Roche, AbbVie, Bristol-Myers Are Latest To Win European Medicines Agency's CHMP Positive Opinion

Bayer AG

Biogen

British American Tobacco

GlaxoSmithKline

Imperial Brands PLC

Lockheed Martin

Philip Morris

Sanofi

Our 3-step process focuses on wide-moat stocks (as per Morningstar's rating). e are only interested in those targets that are attractively valued in historical comparison.

Wide-Moat Stocks On Sale - The May 2021 Heat Map

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 spectrum 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. NMOSD is a rare, lifelong and debilitating autoimmune disorder of the central nervous system, often misdiagnosed as multiple sclerosis, that primarily damages the optic nerve(s) and spinal cord, causing permanent blindness, muscle weakness and paralysis. The disease is characterised by unpredictable relapses and severe disability often occurs following the first NMOSD attack, accumulating with each subsequent relapse. Preventing these relapses is the primary goal for disease management. ENSPRYNG has been recommended for use in people who have only experienced a single NMOSD attack and adolescents, currently unserved NMOSD populations, as well as those with more advanced disease. “Today's positive CHMP opinion is an important step toward bringing ENSPRYNG to people in the EU living with NMOSD who have limited treatment options,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “ENSPRYNG has been shown to reduce the risk of relapse significantly, while also offering a favourable safety profile. Additionally, if approved, ENSPRYNG would be the first and only treatment that can be self-administered subcutaneously at home following appropriate training.” ENSPRYNG is a humanised monoclonal antibody designed to target and inhibit interleukin-6 (IL-6) receptor activity, believed to play a key role in the inflammation associated with NMOSD. The treatment was designed by Chugai, a member of the Roche Group, using novel recycling antibody technology which, compared to conventional technology, allows for longer duration of antibody circulation and subcutaneous dosing every four weeks after an initial loading dose. The CHMP recommendation is based on the results of the Phase III SAkuraStar and SAkuraSky studies in which ENSPRYNG showed robust and sustained efficacy results in reducing the risk of relapse and a favourable safety profile in people with AQP4-IgG seropositive NMOSD. A final decision regarding the approval is expected from the European Commission in the near future. About SAkuraStar and SAkuraSky in NMOSD SAkuraStar was a pivotal Phase III study evaluating the efficacy and safety of ENSPRYNG monotherapy administered to adults with neuromyelitis optica spectrum disorder (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. SAkuraSky was a pivotal Phase III study evaluating the efficacy and safety of ENSPRYNG in combination with baseline immunosuppressive therapy in adults and adolescents with NMOSD. Overall, 92% of AQP4-seropositive participants receiving ENSPRYNG in combination with immunosuppressants remained relapse free at 48 and 96 weeks, compared with 60% and 53% with placebo at 48 and 96 weeks. The primary endpoint of both the SAkuraStar and SAkuraSky studies was time to first protocol-defined relapse (PDR) adjudicated by an independent review committee in the double-blind period. ENSPRYNG demonstrated 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. There is some evidence that people of African or Asian descent may also experience a more severe disease course. 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, triggering the inflammation cascade and leading to damage and disability. ENSPRYNG was designed using novel recycling antibody technology which, compared to conventional technology, allows for longer duration of the antibody and 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 includes two studies: SAkuraStar and SAkuraSky. ENSPRYNG is currently approved in 20 countries, including the United States, Canada, Japan and Switzerland. Applications are under review with numerous regulators. 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. 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.that 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

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) 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.

Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy

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Boston-area biotech Replimune Group Inc. (NASDAQ:REPL) just boosted its executive lineup with a heavy hitter, and the market seems to like the addition.

Analysts See Plenty of Upside for Replimune

Roche Holdings' (RHHBY) CEO Severin Schwan on First Quarter Sales 2021 - Earnings Call Transcript

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 tender offer expired at 12:00 midnight, Eastern Time, at the end of the day on 21 April 2021 and was not extended.

Roche purchases shares in tender offer for GenMark Diagnostics, Inc.

Roche's (RHHBY) performance in the first quarter of 2021 gets negatively impacted by biosimilar competition and coronavirus-related disruptions. Nevertheless, the diagnostics division maintains momentum.

Roche (RHHBY) Q1 Sales Affected by Biosimilars & COVID-19

ZURICH (Reuters) -Swiss drugmaker Roche predicted on Wednesday that demand for its drugs would accelerate for the remainder of 2021, after first-quarter sales of COVID-19 tests offset a pandemic-influenced slump in its main pharmaceuticals business.

Roche's COVID-19 tests boost Q1, CEO sees drug demand accelerating

Demand for healthcare giant Roche's COVID-19 tests helped to offset a decline in the core drugs business, the company said on Wednesday, as it reported sales for the first quarter of 2021 and confirmed its outlook for the year.

Shares in pharma giant Roche rise as COVID-19 tests offset drug sales slump

Roche Holdings AG (OCTMKTS: RHHBY) posted Q1 sales of CHF 14.9 billion, up 3% Y/Y on a constant currency basis and down 1% on a reported basis.  Sales in the Pharmaceuticals Division decreased 9% to CHF 10.6 billion, hit by biosimilars competition, which cut CHF 1.6 billion from revenue.

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