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.

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Else Nutrition Holdings Inc.. has said it will be expanding into Roche Bros.

Else Nutrition expands its Plant-Based Complete Nutrition for Toddlers into Roche Bros. locations this September

JOHANNESBURG--(BUSINESS WIRE)--Roche and the Kolisi Foundation today launched a children's book, Keto and Zuri Learn about COVID-19, that will help parents and caregivers across Africa explain COVID-19 to children by sharing scientific facts in age-appropriate language. The book is available to download for free on both the Kolisi Foundation and Roche's websites, and a limited run of free printed copies will be distributed throughout Africa in seven languages. “We recognize the confusion and co

Roche Partners with the Kolisi Foundation, One By One Target Covid Campaign and Transnet to Launch Free COVID-19 Children's Book

Roche (RHHBY) will withdraw Tecentriq for treating adults with unresectable locally advanced or metastatic triple-negative breast cancer in the United States.

Roche (RHHBY) Withdraws Tecentriq for Breast Cancer in the U.S.

Following a consultation from the FDA, Roche Holdings AG (OTC: RHHBY) has decided to withdraw its immunotherapy, Tecentriq (atezolizumab), to treat a type of breast cancer in the U.S. Earlier this year, Roche withdrew the drug from the U.S. to treat bladder cancer after follow-up studies failed to meet goals.

After Bladder Cancer, Roche Pulls Breast Cancer Indication For Tecentriq In US

Basel, 27 August 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the company has made the decision to voluntarily withdraw the US accelerated approval for 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 a US Food and Drug Administration (FDA)-approved test. Roche made this decision following consultation with the US FDA, based on the agency's assessment of the current mTNBC treatment landscape and in accordance with the requirements of the accelerated approval programme. This decision only impacts the mTNBC indication in the US. It does not affect other approved indications for Tecentriq in the US and outside the US, including mTNBC. This is not related to any changes in either the efficacy or safety associated with Tecentriq.

Roche provides update on Tecentriq US indication for PD-L1-positive, metastatic triple-negative breast cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company has made the decision to voluntarily withdraw the U.S. accelerated approval for 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 tumors express PD-L1, as determined b

Genentech Provides Update on Tecentriq U.S. Indication for PD-L1-Positive, Metastatic Triple-Negative Breast Cancer

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Shape Therapeutics has signed a deal potentially exceeding $3 billion with pharma giant Roche to support the development of gene therapies for Alzheimer's and Parkinson's disease, the Seattle company announced Wednesday.

Seattle biotech firm Shape Therapeutics inks gene therapy deal with Roche worth up to $3B

Shape Therapeutics Inc announced a multi-target strategic collaboration and license agreement with Roche Holding AG (OTC: RHHBY) for RNA editing technology.  Through this partnership, ShapeTX will apply its proprietary RNA editing platform RNAfix and potentially leverage its AAVid technology platform to develop gene therapy for certain targets in certain targets areas of Alzheimer's disease, Parkinson's disease, and rare diseases.

Shape Therapeutics, Roche Form $3B RNA Editing Collaboration

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Roche Holding AG ( RHHBY , Financial) sits atop the list of pharmaceutical companies that are getting the most out of research and development spending. That's an important consideration for investors given new products with blockbuster potential are the lifeblood of the industry.

Roche, AbbVie Top R&D Productivity in Past 5 Years

One ARK Invest exchange-traded fund run by ETF star Cathie Wood sold over 185,000 shares of Swiss multinational health care company Roche on Friday, as the share price of the fund traded up over 1% in the day's session.

Cathie Wood's ARK Invest Sells Over 185,000 Shares of Roche

One ARK Invest exchange-traded fund run by ETF star Cathie Wood sold over 175,000 shares of Roche Holding AG (NYSEARCA: RHHBY) on Thursday, as the share price of this fund traded down nearly 2% in the day's session.

Cathie Wood's ARK Invest Sells Over 175,000 Shares of Roche

Regeneron Pharmaceuticals

The U.K. drug regulator has approved an antibody cocktail developed by Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Roche Holding AG (OTC: RHHBY) to prevent and treat COVID-19. The U.K. chief medical officers confirmed the antibody would be rolled out on the National Health Service in the coming weeks.

UK Approves Regeneron - Roche's COVID-19 Antibody Cocktail

Analog Devices

Analog Devices, Inc. (ADI) CEO Vince Roche on Q3 2021 Results - Earnings Call Transcript

Basel, 18 August 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel, advancing the company's commitment to personalised healthcare through tests that determine which patients are most likely to benefit from specific and targeted therapies. The VENTANA MMR RxDx Panel is the first companion diagnostic test to aid in identifying patients whose solid tumours are deficient in DNA mismatch repair (MMR), who may be eligible for JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD-1 immunotherapy from GSK. The test evaluates a panel of MMR proteins in tumours to provide important treatment information to clinicians. MMR is a naturally occurring mechanism that scans our DNA, correcting errors that cause disease. When MMR is deficient (dMMR), cells mutate, which can lead to cancer. While MMR deficiency is most common in endometrial cancer, other high prevalence dMMR tumour types include gastric, colorectal, small intestine, cervical and neuroendocrine cancers. In the U.S., prevalence of dMMR across patients with solid tumours has been estimated at 14 percent.3 PD-1 inhibitors can be effective treatment in cancers with MMR deficiency. "As the first companion diagnostic of its kind, this test can help qualify patients with solid tumours that are deficient in MMR who have progressed in their disease and who have no other suitable treatment options,” said Thomas Schinecker, CEO Roche Diagnostics. “Based on the results of our MMR biomarker test, these patients may be eligible to receive GSK's JEMPERLI. We are pleased that our innovative companion diagnostic label continues to grow to serve more patients.” FDA approval of the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated panel of MMR biomarkers tested by immunohistochemistry (IHC), enabling impactful treatment decisions for patients. JEMPERLI was approved by the FDA on 17 August 2021 for the treatment of adult patients with dMMR recurrent or advanced solid tumours, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. This indication received accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may depend on verification and description of clinical benefit in a confirmatory trial(s).The VENTANA MMR RxDx Panel and JEMPERLI were earlier approved by the FDA for use in endometrial cancer in April 2021. Read more about Roche innovation in MMR biomarker testing. A bout the VENTANA MMR RxDx Panel The VENTANA MMR RxDx Panel is a label expansion of Roche's current on-market VENTANA MMR IHC Panel. The VENTANA MMR RxDx Panel is intended for the assessment of expression of MMR proteins in formalin-fixed, paraffin-embedded (FFPE) tumour tissue stained with OptiView DAB IHC Detection Kit and ancillary reagents in the panel for VENTANA anti-MLH1 (M1), VENTANA anti-MSH2 (G219-1129) and VENTANA anti-MSH6 (SP93) and OptiView DAB IHC Detection Kit with the OptiView Amplification Kit and ancillary reagents for VENTANA anti-PMS2 (A16-4) on a BenchMark ULTRA instrument. DNA mismatch repair (MMR) proteins have been clinically proven to be predictive biomarkers for PD-1 targeted therapy; specifically, a loss of expression of one or more MMR proteins might predict an increased likelihood of response to such therapy.4,5,6 PD-1 inhibitors can be effective in cancers with MMR deficiency.4,6 MMR is a conserved molecular mechanism that functions to correct the improper base substitutions that spontaneously occur during DNA replication. Defects in the MMR machinery have been attributed to mutations in the MMR proteins. 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. References [1] Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020:70(1):7-30.[2] Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019:69(1):7-34[3] Lorenzi M, Amonkar M, Zhang J, et al. Epidemiology of microsatellite instability high (MSI-H) and deficient mismatch repair (dMMR) in solid tumors: a structured literature review. J Oncol. 2020. doi.org/10.1155/2020/1807929 [4] Lee YC, S Lheureux, and AM Oza. Treatment strategies for endometrial cancer: current practice and perspective. Curr Opin Obstet Gynecol. 2017:29:47-58.[5] GSK website, https://www.gsk.com/en-gb/media/press-releases/data-from-garnet-study-indicates-robust-activity-of-dostarlimab-in-patients-with-advanced-or-recurrent-endometrial-cancer/[6] Kato M, Takano M, Miyamoto M, et al. DNA mismatch repair-related protein loss as a prognostic factor in endometrial cancers. J Gynecol Oncol. 2015:26(1):40-45. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Roche receives FDA approval for first companion diagnostic to identify dMMR solid tumour patients eligible for anti-PD-1 immunotherapy

Roche Holding AG ROG, +0.45% said Monday that Actemra, its rheumatoid arthritis drug that recently received authorization in the U.S. as a COVID-19 treatment for hospitalized patients, is in short supply and will be so for weeks or months. The drug "has been widely used to treat hospitalized patients with severe or critical COVID-19 around the world, and demand for this medicine has increased to unprecedented levels globally," the company said.

Roche says arthritis drug authorized to treat hospitalized COVID-19 patients is in short supply

Roche Holdings AG's (OTCQX: RHHBF) drug Actemra, or tocilizumab, was granted FDA emergency use authorization for critically ill COVID-19 patients after showing it cut the risk of death.  Less than two months after that development, the company is running out of supplies of the drug.

Roche's Arthritis Drug, Used As COVID-19 Treatment, Faces Supply Shortage

ABIDJAN, Côte d'Ivoire--(BUSINESS WIRE)-- #bestplacestowork--Roche has been officially recognized as one of the best places to work in Ivory Coast for 2021 according to the annual prestigious “Best Places To Work” certification program. Roche employees ranked the company high on employee conditions, workplace culture and HR policies recognizing the company as one of the rewarding places to work where people can unlock their potential in a diverse and inclusive workplace. Best Places to Work is an international cer

Roche Earns the Best Place To Work Certification in Ivory Cost for 2021

Daiichi Sankyo Co Ltd

AstraZeneca plc (NASDAQ: AZN) and Daiichi Sankyo Co Ltd (OTC: DSKYF) have announced high-level results from the head-to-head DESTINY-Breast03 Phase 3 trial of Enhertu. The trial reached its primary endpoint in a study including HER2-positive metastatic breast cancer patients who had previously been treated with one prior line of HER2-based therapy.

AstraZeneca, Daiichi Sankyo's Enhertu Shows Improved PFS Over Roche's Kadcyla In Breast Cancer

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Basel, 9 August 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the pivotal phase III POLARIX trial investigating Polivy® (polatuzumab vedotin) in combination with MabThera®/Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) versus MabThera/Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), met its primary endpoint by demonstrating significantly improved and clinically meaningful progression-free survival in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Safety outcomes were consistent with those seen in previous trials. “Since 40% of people with DLBCL relapse after initial therapy, achieving meaningful treatment effects in the front-line setting has the potential to be transformative,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “This Polivy regimen is the first in two decades to improve progression-free survival in DLBCL compared to the standard of care, and we look forward to sharing these results with health authorities to bring this important potential new treatment option to patients as soon as possible.” Today's POLARIX results will be presented at an upcoming medical meeting and submitted to health authorities as part of Roche's commitment to transforming the treatment of DLBCL by providing options tailored to patient and healthcare professional needs. Roche would like to thank all investigators, academic partners and people with DLBCL who participated in the study. Currently, Polivy is used as an off-the-shelf, fixed-duration treatment option in the relapsed or refractory (R/R) DLBCL setting, and is approved in combination with bendamustine and MabThera/Rituxan for the treatment of R/R DLBCL in more than 60 countries worldwide, including in the EU and in the US. Roche continues to explore areas of unmet need where Polivy has the potential to deliver benefit, with ongoing studies investigating combinations of Polivy with the CD20xCD3 T-cell engaging bispecific antibodies mosunetuzumab and glofitamab, with Venclexta®/Venclyxto® (venetoclax), which is being developed by AbbVie and Roche, and with MabThera/Rituxan in combination with gemcitabine and oxaliplatin in the phase III POLARGO study. About the POLARIX study POLARIX [NCT03274492] is an international phase III, randomised, double-blind, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of Polivy® (polatuzumab vedotin) plus MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) versus MabThera/Rituxan, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Eight-hundred and seventy-nine patients were randomised 1:1 to receive either Polivy plus R-CHP plus a vincristine placebo for six cycles, followed by MabThera/Rituxan for two cycles; or R-CHOP plus a Polivy placebo for six cycles, followed by two cycles of MabThera/Rituxan. The primary outcome measure is progression-free survival as assessed by the investigator using the Lugano Response Criteria for malignant lymphoma. POLARIX is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC). About the LYSA and the LYSARC The Lymphoma Study Association, or LYSA, is the internationally leading cooperative group for lymphoma research in Europe, conducting clinical studies ranging from the first tests of new medicines in humans to the establishment of reference therapeutic strategies. LYSA includes in its network more than 120 care centres distributed throughout four countries (France, Belgium, Portugal, Israel), and collaborates with many scientific teams at the international level. The Lymphoma Academic Research Organisation, or LYSARC, is the LYSA operational structure that conducts clinical research projects on lymphomas at the international level. About Polivy ® ( polatuzumab vedotin ) Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B-cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies.1,2 Polivy binds to cancer cells such as CD79b and kills these B-cells through the delivery of an anti-cancer agent, which is thought to minimise the effects on normal cells.3,4 Polivy is being developed by Roche using Seagen ADC technology and is currently being investigated for the treatment of several types of NHL. Polivy is marketed in the US by Genentech as Polivy (polatuzumab vedotin-piiq), with piiq as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration. About diffus e large B-cell lymphoma (DLBCL) DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for about one in three cases of NHL.5 DLBCL is an aggressive (fast-growing) type of NHL.6 While it is generally responsive to treatment in the frontline, as many as 40% of patients will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.[6] Approximately 150,000 people worldwide are estimated to be diagnosed with DLBCL each year.7 About Roche in haematology Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, and Hemlibra® (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. 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. References [1] Dornan D, et al. Therapeutic potential of an anti-CD79b antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of non-Hodgkin lymphoma. Blood 2009;114:2721-29.[2] Pfeifer M, et al. Anti-CD22 and anti-CD79B antibody drug conjugates are active in different molecular diffuse large B-cell lymphoma subtypes. Leukemia 2015;29:1578-86.[3] Ducry L, et al. Antibody-drug conjugates: linking cytotoxic payloads to monoclonal antibodies. Bioconjug Chem 2010;21:5-13.[4] ADC Review. What are antibody-drug conjugates? [Internet; cited 2021 July]. Available from: https://adcreview.com/adc-university/adcs-101/antibody-drug-conjugates-adcs/ .[5] World Health Organization Classification of Tumours of Haematopoietic and Lymphoid Tissues. IARC Press; 2008.[6] Maurer JM, et al. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol 2014;32:1066-73.[7] Globocan 2020. World Fact Sheet. [Internet; cited 2021 July]. Available from: http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

[Ad hoc announcement pursuant to Art. 53 LR] Phase III study shows Roche's Polivy plus R-CHP is the first regimen in 20 years to significantly improve outcomes in previously untreated aggressive form of lymphoma compared to standard of care

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the pivotal Phase III POLARIX trial investigating Polivy® (polatuzumab vedotin) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) versus Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) met its primary endpoint by demonstrating significantly improved and clinically meaningful progre

Phase III Study Shows Genentech's Polivy Plus R-CHP Is the First Regimen in 20 Years to Significantly Improve Outcomes in Previously Untreated Aggressive Form of Lymphoma Compared to Standard of Care

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The FDA has granted priority review for Genentech's, a unit of Roche Holdings AG (OTC: RHHBY) Tecentriq (atezolizumab), as adjuvant treatment for certain patients with early non-small cell lung cancer.  The application covers patients following surgery and platinum-based chemotherapy with non-small cell lung cancer whose tumors express PD-L1≥1%.

News for Roche Holding AG Stock (RHHBY)