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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Roche, a world leader in integrated Personalised Diabetes Management, and the Zur Rose Group, provider of a European digital healthcare ecosystem, announce their collaboration to improve everyday therapy management and better address the needs of 60 million people living with diabetes in Europe [1]  The collaboration will empower people with diabetes to self-manage their condition for a better quality of life and enable healthcare professionals to efficiently provide optimal and integrated care BASEL, Switzerland , Oct. 28, 2021 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) and the Zur Rose Group today announced a collaboration to empower people with diabetes and their caregivers in their daily therapy management. In Europe, there are 60 million people living with diabetes, i.e.

Roche and the Zur Rose Group announce collaboration to offer innovative health journeys for people living with diabetes

Basel, 25 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has launched the AVENIO Tumor Tissue CGP Kit. The Kit complements the current CGP portfolio offered by Roche and Foundation Medicine and allows laboratories to expand their oncology research in-house. Ultimately, a future version of the kit may lead to additional resources for clinicians to use in the diagnosis and treatment of cancer.

Roche launches comprehensive genomic profiling kit to expand access to personalised cancer research

(Reuters) -Swiss drugmaker Roche Holding AG said on Friday the U.S. health regulator approved its eye implant for patients with a chronic disorder causing blurred vision, giving them an alternative to receiving monthly eye injections with existing treatments.

Roche's implant for chronic eye disorder wins FDA approval

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Wet AMD is a potentially

FDA Approves Genentech's Susvimo, a First-of-Its-Kind Therapeutic Approach for Wet Age-Related Macular Degeneration (AMD)

Basel, 22 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with neovascular or “wet” age-related macular degeneration (nAMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Neovascular AMD is a potentially blinding condition that requires treatment with eye injections as often as once a month.1 ,2,3,4 Susvimo, previously called Port Delivery System with ranibizumab, is the first and only FDA-approved treatment for nAMD that offers as few as two treatments per year.5,6

FDA approves Roche's Susvimo, a first-of-its-kind therapeutic approach for neovascular or “wet” age-related macular degeneration (nAMD)

Basel, 22 October 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA PD-L1 (SP263) Assay in non- small cell lung cancer (NSCLC) as a companion diagnostic test for Tecentriq, advancing the company's commitment to guide clinical decision making through innovative, high quality assays that improve patient access to personalized healthcare.

Roche's VENTANA PD-L1 (SP263) Assay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq® (atezolizumab)

Roche (RHHBY) immuno-oncology drug Tecentriq gets FDA approval for yet another indication of lung cancer.

Roche's (RHHBY) Tecentriq Gets FDA Nod for Another Indication (Revised)

Roche Holding AG (OTC: RHHBY) raised its 2021 sales forecast after posting an 8% rise in nine-month revenues, driven by demand for COVID-19 tests and the strong performance in the broader business. Group sales in the nine months to September rose to CHF46.68 billion from CHF43.98 billion, as diagnostics division sales jumped 39%.

Roche Expects Higher FY21 Sales As Delta Variant Boosts Demand For Diagnostics

Roche (RHHBY) posts an encouraging performance in the third quarter and the first nine months of 2021 driven by demand for coronavirus tests due to the Delta variant and recovery in pharma sales.

Roche (RHHBY) 9M21 Sales Grow on Strong COVID-19 Tests, View Up

Roche reports higher sales and lifts full-year outlook

Roche raised its 2021 sales forecast on Wednesday after the Swiss drugmaker posted an 8% rise in nine-month revenues, powered by demand for COVID-19 tests and strength in the overall business helped by newly launched diagnostics platforms.

Roche raises 2021 outlook as COVID-19 tests continue powering sales

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong growth in the first nine months – outlook for 2021 raised

Roche is a giant among pharmaceutical companies and carries a stellar balance sheet. Newer drugs, including those in oncology, now represent over half of Roche's pharmaceutical sales.

Roche: One Of The Best Pharma Stocks You Can Buy

Roche's (RHHBY) Tecentriq Gets FDA Nod for Another Indication

The FDA has greenlit Roche Holdings AG's (OTC: RHHBY) Tecentriq and platinum-based chemotherapy as post-surgery treatment for non-small cell lung cancer with the expression of the PD-L1 biomarker covering at least 1% of tumor cells.  Related:   After Bladder Cancer, Roche Pulls Breast Cancer Indication For Tecentriq In US.

Roche's Tecentriq Wins FDA Approval In Adjuvant Lung Cancer Setting

SANTA CLARA, Calif., Oct. 18, 2021 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has entered an agreement with Ibex Medical Analytics, a global leader in artificial intelligence (AI)-based cancer diagnostics.

Roche announces collaboration with Ibex Medical Analytics to develop artificial intelligence-based digital pathology applications for improved patient care

The head of Roche's controlling group of shareholders is "very confident" stability can be maintained at the pharmaceuticals company after the next generation of heirs joined the family pool of investors, he told NZZ am Sonntag.

Roche family shareholders will maintain stability - vice chairman

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Basel, 15 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%, as determined by an FDA-approved test.

US FDA approves Roche's Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥1%, as determined by an FDA-approved test. “Tecentriq is now the first and only cancer immunotherapy available for a

FDA Approves Genentech's Tecentriq as Adjuvant Treatment for Certain People With Early Non-Small Cell Lung Cancer

Basel, 15 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has entered an agreement with PathAI, a global leader in artificial intelligence (AI)-powered technology for pathology. Under the development and distribution agreement, the companies will jointly develop an embedded image analysis workflow for pathologists. This workflow will allow PathAI image analysis algorithms to be accessed within NAVIFY Digital Pathology, the cloud version of Roche's uPath enterprise software. This collaboration is now possible through Roche's Digital Pathology Open Environment, which allows pathologists to securely access third-party AI-powered technology alongside Roche's growing menu of AI-based image analysis tools.

Roche announces PathAI collaboration for artificial intelligence-based digital pathology applications for improved patient care

Basel, 14 October 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new longer-term efficacy and safety data for ENSPRYNG® (satralizumab). The data show ENSPRYNG has a favourable benefit:risk profile and is effective in reducing relapses over four years of treatment in people with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), a rare debilitating disease that affects the central nervous system. Efficacy and safety results from the open-label extension (OLE) periods of the SAkuraStar and SAkuraSky studies, in addition to the design of SAkuraBONSAI, a new study in people with AQP4-IgG seropositive NMOSD who are treatment naïve, or where prior rituximab (or biosimilar) treatment has failed, will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

New four-year data show Roche's ENSPRYNG significantly reduces debilitating relapses in people with neuromyelitis optica spectrum disorder

Basel, 14 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced European Medicines Agency (EMA) approval of a new, shorter 90-minute Gazyvaro® (obinutuzumab) infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma (FL). The approval is based on a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP). The regular rate of infusion can take approximately three to four hours, so administering over a shorter time period can result in time savings for patients and could also reduce pressure on healthcare systems. This is especially important given the ongoing challenges for healthcare systems around the world brought about by the COVID-19 pandemic.[1] “Gazyvaro has improved outcomes for people with follicular lymphoma, and now has the additional benefit of a shorter infusion time,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “Reducing the amount of time patients need to be in hospital has the potential to improve their treatment experience whilst also increasing efficiency for institutions and healthcare systems.” The approval is based on the phase IV GAZELLE study and other supportive studies investigating Gazyvaro in previously treated and untreated FL patients. The efficacy and safety of the GAZELLE study were consistent with that demonstrated by Gazyvaro administered at the regular rate of infusion. The trial showed that no patients experienced Grade 3 or higher infusion-related reactions during treatment cycle 2 with short duration infusion Gazyvaro, and no unexpected safety findings were found, supporting its use. Following this approval, Gazyvaro's label update is being implemented immediately and Roche is aiming to launch short duration infusion Gazyvaro for patients in the EU with previously treated and untreated advanced FL as soon as possible. Gazyvaro is already approved for the treatment of FL, and now shorter duration infusion Gazyvaro will offer another more convenient option to enhance FL patients' treatment experiences. In the US, Europe and multiple other countries, Gazyva®/Gazyvaro is currently approved in combination with chlorambucil for patients with previously untreated chronic lymphocytic leukaemia (CLL). It is also approved in combination with bendamustine, followed by Gazyva/Gazyvaro maintenance for the treatment of FL patients who did not respond to a MabThera®/Rituxan® (rituximab)-containing regimen, or whose FL returned after such treatment and in combination with chemotherapy for previously untreated advanced FL. About the GAZELLE s tudy GAZELLE [ NCT03817853 ] is an open-label, international, multicentre, single arm, phase IV study investigating the safety and efficacy of the short duration infusion (SDI; target 90-minute infusion) of Gazyvaro® (obinutuzumab) administered in combination with chemotherapy in patients with previously untreated advanced follicular lymphoma (FL). Patients who did not experience Grade 3 or higher infusion-related reactions were eligible to receive short duration infusion Gazyvaro from cycle 2. The primary endpoint of the study was the proportion of patients who experience Grade 3 or higher infusion-related reactions associated with short duration infusion during cycle 2 (the first treatment cycle with short duration infusion). About Gazyvaro® (obinutuzumab) Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein expressed on B-cells, including malignant B-cells, but not on stem cells or plasma cells. Gazyvaro is designed to attack and destroy targeted B-cells both directly and together with the body's immune system. Gazyvaro is marketed as Gazyva® in the US. In the US, Europe and multiple other countries, Gazyva/Gazyvaro is currently approved in combination with chlorambucil for patients with previously untreated chronic lymphocytic leukaemia (CLL). It is also approved in combination with bendamustine, followed by Gazyva/Gazyvaro maintenance for the treatment of FL patients who did not respond to a MabThera®/Rituxan® (rituximab)-containing regimen, or whose FL returned after such treatment and in combination with chemotherapy for previously untreated advanced FL. Additional combination studies investigating Gazyvaro with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers. About follicular lymphoma Follicular lymphoma (FL) is the most common indolent (slow-growing) form of non-Hodgkin lymphoma (NHL), accounting for about one in five cases of NHL.[2] It is considered incurable and relapse is common. It is estimated that more than 100,000 people are diagnosed with FL each year worldwide, including over 30,000 people in Europe.[3] 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 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] Canales MA, et al. Ongoing Study of Obinutuzumab Short Duration Infusion in Patients with Previously Untreated Advanced Follicular Lymphoma. Blood. 2019;134(Supplement_1):5269.[2] Shankland KR, Armitage JO, Hancock BW. Non-Hodgkin lymphoma. Lancet. 2012;380(9844):848-57.[3] World Health Organisation. GLOBOCAN 2020, Cancer Incidence and Mortality: IARC CancerBase No. 11 [Internet; cited 2021 September]. Available from: https://gco.iarc.fr/today/online-analysis-table?v=2020&mode=cancer&mode_population=c ontinents&population=900&populations=908&key=asr&sex=0&cancer=39&type=0&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&group_cancer=1&include_nmsc=1&include_nmsc_other=1#collapse-group-1-4-0 Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Roche's Gazyvaro shorter 90-minute infusion time approved in Europe for people with previously treated or untreated follicular lymphoma

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new longer-term efficacy and safety data for Enspryng™ (satralizumab-mwge). The data show Enspryng has a favorable benefit-risk profile and is effective in reducing relapses over four years of treatment in people with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD, a rare debilitating disease that affects the central nervous system. Efficacy and safety resu

New 4-Year Data Show Genentech's Enspryng (satralizumab-mwge) Significantly Reduces Debilitating Relapses in People With Neuromyelitis Optica Spectrum Disorder

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