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, 07 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has extended the marketing authorisation for Actemra®/RoActemra® (tocilizumab) to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.1 This decision comes just hours after the recommendation by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), reflecting the urgent need for Actemra/RoActemra as a potential treatment option during the COVID-19 public health emergency.

Actemra/RoActemra approved by the European Commission to treat patients with severe COVID-19

TUCSON, Ariz., Dec. 7, 2021 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the research use only (RUO) launch of three new automated digital pathology algorithms, uPath Ki-67 (30-9), uPath ER (SP1) and uPath PR (1E2) image analysis for breast cancer, which are important biomarkers for breast cancer patients.

Roche announces the release of its newest artificial intelligence based digital pathology algorithms to aid pathologists in evaluation of breast cancer markers, Ki-67, ER and PR

Basel, 6 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it completed the repurchase of Roche shares that had been held by Novartis. On 4 November 2021, Roche and Novartis had announced this repurchase. The Extraordinary General Meeting of Roche Holding Ltd passed the resolutions required for the repurchase and the capital reduction on 26 November 2021. In accordance with the respective resolution of the Extraordinary General Meeting of 26 November 2021, the 53,309,000 shares have now been repurchased by Roche and the corresponding consideration has been transferred to Novartis. The repurchased shares will be cancelled upon completion of the corresponding procedure. Christoph Franz, Chairman of the Board of Directors of Roche: "With this transaction, we regain full strategic flexibility without compromising our operational scope of action. Rating agencies have confirmed the high quality of our ratings. On the basis of an unchanged dividend policy, all holders of Roche equity securities will benefit from the repurchase and the resolved capital reduction by cancellation of the repurchased shares and the earnings accretion resulting therefrom." As previously announced, the transaction does not change the communicated outlook for the full year. Roche expects a mid-single-digit sales growth at constant exchange rates. Core EPS growth at constant exchange rates is targeted to be broadly in line with sales growth. Furthermore, Roche is aiming at increasing the dividend in Swiss francs also for 2021. 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, the company 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 thirteenth consecutive year, Roche has been recognised as one of the most sustainable companies in the pharmaceutical 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 completed the repurchase of Roche shares from Novartis

Basel, 06 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended extending the marketing authorisation for Actemra ® /RoActemra ® (tocilizumab) to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. A final decision regarding the approval of Actemra/RoActemra is expected from the European Commission in the near future.

CHMP recommends EU approval of Actemra/RoActemra to treat patients with severe COVID-19

Basel, 6 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced its plans to launch the SARS-CoV-2 & Flu A/B Rapid Antigen Test for professional use in markets accepting the CE Mark by the beginning of January. Roche also intends to file for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) in early 2022.

Roche to launch SARS-CoV-2 & Flu A/B Rapid Antigen Test in countries accepting the CE Mark to enable rapid differentiation of viral respiratory infections

AbbVie

Amgen

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Gilead Sciences

Eli Lilly

Merck

Pfizer

Roche is optimally diversified both in terms of geography and in terms of portfolio. Pfizer and Eli Lilly are also broadly diversified but are more U.S.-centric companies. AbbVie, but also Merck are currently over-reliant on a single drug but this appears to be priced into the stocks accordingly.

Diversify, Diversify - Concentration Risks Of Several Pharma Companies

Roche board member Paul Bulcke, the current chairman of Nestle, will stand down from the Swiss drug-maker's board of directors after its annual general meeting next year, the company said on Friday.

Roche says Nestle Chairman Bulcke to leave its board of directors

Basel, 3 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that at its December meeting the Board of Directors of Roche Holding Ltd has approved first proposals to the Annual General Meeting (AGM) scheduled for 15 March 2022.

Changes in the Board of Directors

Roche ROG, +0.04% and its newly acquired subsidary TIB Molbiol said Friday that they have developed three new research test kits to differentiate mutations in the omicron variant of coronavirus that causes COVID. The Swiss pharmaceutical announced the new kits are among the first to specify those mutations, and can help manage the pandemic.

Roche unit develops new testing kits to detect mutations in omicron variant

Basel, 3 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and TIB Molbiol, a newly acquired subsidiary within the Roche Diagnostics division, have added three additional Research Use Only (RUO) test kits for the detection of mutations present in the novel B.1.1.529 Omicron SARS-CoV-2 variant: VirSNip SARS Spike ins214EPE (RUO), VirSNiP SARS-CoV-2 Spike S371L S373P (RUO), VirSNip SARS Spike E484A (RUO). The World Health Organization (WHO) has classified the recently emerged SARS-CoV-2 variant, Omicron (B.1.1.529), as a COVID-19 variant of concern (VOC). The VirSNiP variant kits allow differentiation between unique mutations present within the Omicron variant compared to other SARS-CoV-2 variants and are for use on LightCycler® and cobas® z 480 analysers. Using a technology called qPCR (quantitative polymerase chain reaction) they can help researchers with improved variant detection and viral research, and are among the first to address the number of unique mutations of the Omicron variant. “The COVID-19 pandemic continues to be an evolving and complex situation, and Roche is committed to responding to healthcare's biggest challenges. The teams at TIB Molbiol have worked around the clock since the new variant emerged, and today we are able to offer a test that can specifically identify the novel B.1.1.529 Omicron SARS-CoV-2 variant to help better understand its spread and behaviour,” said Thomas Schinecker, CEO Roche Diagnostics. “There is still much to learn about Omicron. It's critical to identify Omicron quickly and accurately, which will help inform ongoing research - including the further development of therapeutics and vaccines - and potentially stop or slow down the advance of this new variant.” The test kits have been developed by TIB Molbiol, with Roche announcing the legal completion of the purchase agreement of the Berlin-based company on 1 December 2021. This has enabled Roche to deliver an agile response to the evolving variant situation. TIB Molbiol's researchers work in collaboration with their academic contacts to continually screen for new variants and emerging diseases allowing a fast and effective response to emerging healthcare needs. At the onset of the COVID-19 pandemic, TIB Molbiol and Roche provided the first research use only SARS-CoV-2 detection test in January 2020, only days after the new coronavirus was first sequenced. About the assays TIB Molbiol offers a broad range of VirSNiP variant kits for the detection of key spike protein mutations. TIB Molbiol has now added three additional research use only (RUO) VirSNiP kits for the detection of mutations present in the novel B.1.1.529 Omicron SARS-CoV-2 variant: VirSNip SARS Spike ins214EPE (RUO), VirSNiP SARS-CoV-2 Spike S371L S373P (RUO), VirSNip SARS Spike E484A (RUO). They can be used for SARS-CoV-2 virus research as well as detecting mutations of SARS-CoV-2 variants. VirSNiP kits are for research use only, not for diagnostic procedures. The mutations in the Omicron variant do not affect the performance of the LightMix® Modular SARS-CoV-2 (COVID19) N-gene, E-gene, nor RdRP-gene kits. These kits are launched globally (excluding the USA). Roche also offers in vitro diagnostic (IVD) tests to accurately diagnose COVID-19 and the cobas® SARS-CoV-2 Variant Set 1 test (RUO) for use on the cobas® 6800/8800 Systems, which is an automated, multiplex, real-time reverse transcription polymerase chain reaction (RT-PCR) assay for the rapid in vitro qualitative detection and discrimination of selected SARS-CoV-2 mutations E484K, N501Y and deletion HV-69/70 in e.g. nasal and nasopharyngeal swab specimens collected viral transport media (VTM). The test is designed to be used with known SARS-CoV-2 positive samples and to support the understanding of variant epidemiology for Population Health Management. Based on initial analysis, the cobas® SARS-CoV-2 Variant Set 1 test (RUO) is predicted to detect one of the Omicron variant mutations known as del 69-70 in the spike protein, the region that enables the virus to attach to and enter the human cell. It can therefore be used as a tool to presumptively identify Omicron. Roche is currently working to generate additional data to supplement our analysis around this test. About TIB Molbiol TIB Molbiol is a subsidiary of Roche Diagnostics that has supplied the global market with reagents for research and medical diagnostics for over 30 years. As a manufacturer of custom oligonucleotides the company partnered in the development of molecular diagnostics and built a broad portfolio of diagnostic assays, in particular for inherited genetic as well as somatic mutation testing, quantitative assays for haematology and transplantation medicine. The majority of assays are used to test for infectious diseases. They are available as modular kits, enabling the creation of symptomatic panels by combining assays, including emerging pathogens. To support customers performing human genotyping, TIB Molbiol provides custom-made LightSNiP assays for SNP analysis. TIB Molbiol is headquartered in Berlin (Germany). For more information about the tests and system, please visit www.diagnostics.roche.com. About Roche's response to the COVID-19 pandemic As a leading healthcare company, we are doing all we can to support countries in their fight against COVID-19 and minimising its impact. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection, as well as providing digital support to healthcare systems. We also continue to identify, develop, and support therapies which can play a role in treating the disease. The impact of COVID-19 goes beyond those who contract it. That is why we are working with healthcare providers, laboratories, authorities, and organisations to help make sure patients continue to receive the tests, treatment and care they need during these challenging times. Building on a longstanding tradition of partnerships, we are working together with governments and others to make healthcare stronger and more sustainable in the future. Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic and Roche has so far launched 21 diagnostics solutions to help minimise the impact of COVID-19. As soon as the novel SARS-CoV-2 virus was sequenced in early 2020, we got to work. On 13 March 2020 we became the first company to receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a high-volume molecular test to detect the virus. Since then, we have continued to add a range of diagnostics solutions to our global portfolio to help in the fight against COVID-19. In addition to the gold standard PCR test, we have developed antigen tests to help diagnose the virus in settings where there is limited molecular laboratory infrastructure, rapid antigen tests where the virus can be detected on the spot, tests that can test for both flu and COVID-19 at the same time, both high throughput and at the point of care, and tests that can detect virus antibodies that can help monitor the spread of the virus and can also support in vaccine development. In March 2021 the SARS-CoV-2 variant test was launched, designed to detect key spike mutations. Aside from these tests we have also looked at how we can support care for patients who have COVID-19, receiving an U.S. FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, a digital algorithm that could help simplify the screening, diagnosis, and monitoring of respiratory-compromised patients with COVID-19. Roche is working closely with governments and health authorities around the world, and has significantly increased production to support availability of tests 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, the company 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 thirteenth consecutive year, Roche has been recognised as one of the most sustainable companies in the pharmaceutical 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 has rapidly developed additional testing options to differentiate mutations in the Omicron SARS-CoV-2 variant

Basel, 1 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has completed its share purchase agreement to acquire 100 percent of the outstanding shares of TIB Molbiol Group. TIB Molbiol will continue to operate as a subsidiary within the Diagnostics division. Roche and TIB Molbiol will build on their capabilities for the rapid development of assays for emerging pathogens and potential health threats, such as infectious diseases.

Roche completes purchase agreement with long-term partner TIB Molbiol to expand PCR-test portfolio in the fight against new infectious diseases

Amazon

SEATTLE--(BUSINESS WIRE)--Roche uses AWS cloud capabilities to facilitate research collaboration, deliver new diagnostic technologies, and unlock insights from health data.

AWS Supports Roche in Harnessing the Power of Health Data at Scale

The Swiss pharma needs to get its drug approved first.

Could Roche Put a Crinkle in Biogen's Alzheimer's Drug Launch?

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Our 3-step process focuses on wide-moat stocks (as per Morningstar's rating).

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

Novartis

Roche shareholders voted overwhelmingly on Friday to support the $20.7 billion deal to buy Novartis's nearly one third voting stake, the Swiss drugmaker said.

Roche shareholders approve deal to buy Novartis's stake

Basel, 26 November 2021 – On 4 November 2021, Roche (SIX: RO, ROG; OTCQX: RHHBY) had announced its agreement with Novartis Holding AG (Novartis) regarding the repurchase of the equity stake held by Novartis in Roche. At the same time, Roche had informed that the repurchase was conditional upon, inter alia, the approval by an Extraordinary General Meeting of Roche Holding Ltd of the capital reduction by cancellation of the shares to be repurchased from Novartis and of the interim financial statements prepared for the purpose of this transaction. At today's Extraordinary General Meeting of Shareholders, the Board of Directors therefore proposed the approval of a share capital reduction by cancellation of 53,309,000 bearer shares to be repurchased from Novartis and the approval of the interim financial statements prepared for the purpose of this transaction. Today's Extraordinary General Meeting of Roche approved all proposals of the Board of Directors. The shareholders approved the audited statutory interim financial statements (standalone financial statements) of the Company as of 31 October 2021 with a majority of 100.00% and the share capital reduction by cancellation of the 53,309,000 bearer shares with a nominal value of CHF 1 each to be repurchased from Novartis with a majority of 99.85%. Therefore, the corporate law requirements for the repurchase have been satisfied. The closing of the repurchase transaction is expected to take place in early December 2021. Christoph Franz, Chairman of Roche's Board of Directors: "Today's resolutions of the Extraordinary General Meeting are in the best economic and strategic interest of Roche. As a result, we will be even better positioned to make a contribution to the health of people around the world." In view of the tense pandemic situation and in accordance with applicable law, the Extraordinary General Meeting was held with only the persons in attendance required by law or the Articles of Incorporation at the premises of Roche Holding Ltd at its registered office without the physical attendance of shareholders. Shareholders were able to exercise their rights via written or electronic instructions to the independent proxy, Testaris AG. The independent proxy represented 85.5% of all 160,000,000 bearer shares. 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, the company 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 thirteenth consecutive year, Roche has been recognised as one of the most sustainable companies in the pharmaceutical 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 Extraordinary General Meeting 2021

Analog Devices

Analog Devices, Inc. (ADI) CEO Vincent Roche on Q4 2021 Results - Earnings Call Transcript

Basel, 23 November 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its extensive haematology portfolio will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition from 11-14 December 2021. Roche molecules will be featured in more than 90 abstracts, including 17 oral presentations, showcasing new immunotherapies, unique treatment combinations, the application of novel endpoints, and fixed-duration regimens.

Roche to present new pivotal data at ASH 2021 from broad and comprehensive portfolio, challenging treatment standards for people with blood disorders

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its extensive hematology portfolio will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition from December 11-14, 2021. Genentech molecules will be featured in more than 90 abstracts, including 17 oral presentations, showcasing new immunotherapies, unique treatment combinations, the application of novel endpoints,

Genentech to Present New Pivotal Data at ASH 2021 From Broad and Comprehensive Portfolio, Challenging Treatment Standards for People With Blood Disorders

Roche (RHHBY) wins EC approval for Gavreto for the treatment of adults with RET fusion-positive advanced NSCLC.

Roche (RHHBY) Gets Approval for Gavreto for NSCLC in EU

MINNEAPOLIS--(BUSINESS WIRE)--Flywheel, the leading cloud-scale informatics platform for biomedical research and collaboration, announces a partnership with Roche and Genentech.

Flywheel Partners with Roche and Genentech to Accelerate Development of Personalized Healthcare Solutions

The European Commission (EC) has granted conditional marketing authorization to Roche Holdings AG's (OTC: RHHBY) Gavreto (pralsetinib) for treating adults with a form of non-small cell lung cancer. The approval covers pralsetinib as a monotherapy for treating adults with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

Roche's Gavreto Conditionally Approved In Europe For RET Fusion-Positive Lung Cancer

Basel, 19 November 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has granted conditional marketing authorisation for Gavreto® (pralsetinib) as a monotherapy for the treatment of adults with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. Gavreto is the first and only precision medicine approved in the European Union (EU) for the first-line treatment of people with RET fusion-positive advanced NSCLC.1

European Commission approves Roche's Gavreto (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer

Novartis AG (NYSE: NVS) is getting a massive influx of cash from selling its 20-year stake in Roche Holdings AG (OTC: RHHBY), triggering speculation about where the Company will spend the money.  Another significant acquisition could be next.

Novartis Has $21B From Roche Stake Sale - Which Company Is On Its M&A Radar?

Spark Therapeutics, a unit of Roche Holdings AG (OTC: RHHBY), has announced data from its Phase 1/2 trial of SPK-8011 in hemophilia A.  At a median efficacy follow-up of 33.4 months, the study found that 16 of 18 study participants had sustained factor VIII (FVIII), which permitted prophylaxis cessation and reduction in bleeding episodes.

News for Roche Holding AG Stock (RHHBY)