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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Basel, 24 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its COVID-19 At-Home Test.¹ The test uses a simple anterior nasal swab sample that can be conveniently self-collected and self-tested by individuals aged 14 years and older, and by an adult for children aged 2-13 years old.² The test is able to produce accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron.

Roche COVID-19 At-Home Test granted FDA Emergency Use Authorization to expand access to rapid self-testing solutions in the United States

Roche is a well-diversified pharmaceutical and diagnostics company with a fortress-like balance sheet. The company's voting shares are predominantly held by descendants of the Hoffmann family. Management acts prudently in terms of capital allocation and is far-sighted.

Roche Holding: Benefit From The Relative Discount Of The Non-Voting Shares

Lineage Cell Therapeutics Inc

CARLSBAD, Calif.--(BUSINESS WIRE)---- $LCTX #LineageCellTherapeutics--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), today announced that Lineage and its subsidiary, Cell Cure Neurosciences Ltd., have entered into an exclusive worldwide collaboration and license agreement with Roche and Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), for the development and commercialization of a retinal pigment epithelium (RPE) cell therapy for the treatment of ocular disorders, including advanced dry age-r

Lineage Establishes Exclusive Worldwide Collaboration With Genentech for the Development and Commercialization of OpRegen® RPE Cell Therapy for the Treatment of Ocular Disorders

PLEASANTON, Calif., Dec. 17, 2021 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its cobas® SARS-CoV-2 Qualitative test has received CE mark for the use of saliva samples in the detection of SARS-CoV-2 on the widely available, high-throughput cobas® 6800/8800 Systems.

Roche receives CE mark for the use of saliva samples with cobas SARS-CoV-2 Qualitative test on cobas 6800/8800 Systems

Novartis

Novartis says it will buy back up to $15 billion of its stock, signaling confidence in its growth prospects and its pipeline.

Novartis to Spend Bulk of Roche Windfall on Buying Back Stock, Not M&A

Atea Pharmaceuticals Inc (NASDAQ: AVIR) said it would close the global Phase 3 MORNINGSKY trial. The decision comes after considering the changing COVID-19 landscape with the anticipated availability of new antiviral treatment regimens.

After Roche Walks Away, Atea Puts Break On Late-Stage COVID-19 Oral Antiviral Trial

PLEASANTON, Calif., Dec. 15, 2021 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the first infectious disease tests on the cobas® 5800 System, a new molecular laboratory instrument, in countries accepting the CE mark.

Roche launches the first infectious disease tests and cobas omni Utility Channel for use on the cobas 5800 System in countries accepting the CE Mark

Roche Holdings AG (OTC: RHHBY) announced results from the Phase 3 POLARIX study of Polivy (polatuzumab vedotin) with MabThera/Rituxan (rituximab) and the chemotherapy regimen R-CHOP. Data were presented at the American Society of Hematology (ASH) Annual Meeting and Exposition.

Roche's Polivy Combo Boosts Survival In Early-Stage Lymphoma Patients

Basel, 14 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the phase III POLARIX study showing that treatment with Polivy® (polatuzumab vedotin) in combination with MabThera®/Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) significantly reduced the risk of disease progression, relapse or death (progression-free survival; PFS) by 27% compared with the current standard-of-care, MabThera/Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Safety outcomes were consistent with those seen in previous trials and the safety profile was comparable for Polivy plus R-CHP versus R-CHOP.1 , 2 Results were presented as a late-breaking abstract and during a press briefing at the American Society of Hematology (ASH) Annual Meeting and Exposition on Tuesday, December 14, 2021. Data from POLARIX were simultaneously published in the New England Journal of Medicine (NEJM). The study is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC).

Roche's Polivy combination reduced the risk of disease worsening or death by 27% in people with previously untreated aggressive form of lymphoma

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from the Phase III POLARIX study showing that treatment with Polivy® (polatuzumab vedotin) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) significantly reduced the risk of disease progression, relapse or death (progression-free survival; PFS) by 27% compared with the current standard-of-care, Rituxan plus c

Genentech's Polivy Combination Reduced the Risk of Disease Worsening or Death by 27% in People With Previously Untreated Aggressive Form of Lymphoma

Roche Holdings AG's (OTC: RHHBY) mosunetuzumab, a bispecific targeting the CD20 protein on the surface of tumors and the CD3 protein on T cells, posted a 60% complete response rate. The data comes from nearly 100 patients with third-line-or-later follicular lymphoma in Phase 1/2 study dubbed GO29781.

Roche Uncorks Favorable Responses From Mosunetuzumab In Follicular Lymphoma Settings

Basel, 13 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the AVENIO Edge System, a core component of Roche's strategy to advance sequencing technologies. Built on best-in-class foundational capabilities to deliver a fully-automated, integrated sequencing solution. The AVENIO Edge System is a pre-analytical platform for sequencing library preparation, target enrichment and quantification steps that deliver integrated, end-to-end control with reliable, consistent high-quality results. “Roche is committed to developing diagnostic solutions with the goal of providing the healthcare community with faster and more accurate medical information to predict risk and detect disease,” said Thomas Schinecker, CEO Roche Diagnostics. “We are pleased to offer next-generation sequencing laboratories and translational researchers the new automated AVENIO Edge System that aims to drastically reduce human error and help ensure fast, reliable and accurate results.” Next-generation sequencing samples are precious. Every step of sample preparation has the potential to impact results. The AVENIO Edge System's high reproducibility and low error rate can support the goal of reducing the number of rejected samples which otherwise might have to be re-collected. The new AVENIO Edge System offers ready-to-use components in addition to customisable workflow parameters, making it a scalable, cost-efficient solution for sequencing laboratories seeking high performance and agility. With a setup to initiation of 20 minutes, this walkaway system demonstrated more than a 96 percent lower error opportunity and an 84 percent reduction in hands-on time. The AVENIO Edge System will be available at select locations worldwide with timelines that vary country by country. About the AVENIO Edge System The AVENIO Edge System is Class I, In Vitro Diagnostics (IVD), 510(k) exempt, in the US. It is Class A in the EU in accordance with EU Regulation 2017/746 (IVDR) of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. At launch, the AVENIO Edge Instrument can be used for Research Use Only (RUO) workflows. Consumables are General Laboratory Use (GLU). Compatible reagents and workflows are Research Use Only (RUO). Not for use in diagnostic procedures. The AVENIO Edge System simplifies next-generation sequencing (NGS) and elevates automated sample preparation with integrated workflows, reagents, barcoded consumables and connectivity to enable reliable, high-quality results and the freedom to do more. The AVENIO Edge System delivered high sequencing performance and demonstrated high uniformity, specificity and reproducibility in our in-house technical validation and early customer studies. At an early evaluation study site, the AVENIO Edge System replaced 384 manual steps while preparing 24 DNA libraries in one run versus manually preparing 24 DNA libraries. The AVENIO Edge System is a fully automated liquid handling technology consisting of all-in-one hardware and traceable solutions that guides the operators through the process, provides real-time tracking of samples and delivery of the results to the laboratory information system (LIS). It is intended for routine laboratory tasks and designed to support multiple library prep, target enrichment and quantification workflow steps with customizable parameters. The AVENIO Edge System offers a wide set of modular, barcoded and ready-to-run reagents in addition to customizable workflow parameters, making it a scalable, cost-efficient solution for sequencing laboratories seeking high performance and agility. 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 launches the AVENIO Edge System to simplify and automate next-generation sequencing sample preparation, reduce human error and advance precision medicine

Basel, 13 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from an interim analysis of the phase III HAVEN 6 study, which show Hemlibra® (emicizumab) demonstrated a favourable safety profile and effective bleed control in people with moderate or mild haemophilia A without factor VIII inhibitors.3 The data were presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition as an oral presentation on 12 December 2021.

Interim data from phase III HAVEN 6 study demonstrate favourable safety and efficacy profile of Roche's Hemlibra in people with moderate or mild haemophilia A

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from an interim analysis of the Phase III HAVEN 6 study, which show Hemlibra® (emicizumab-kxwh) demonstrated a favorable safety profile and effective bleed control in people with moderate or mild hemophilia A without factor VIII inhibitors. The data were presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition as an oral prese

Interim Data From Phase III HAVEN 6 Study Demonstrate Favorable Safety and Efficacy Profile of Genentech's Hemlibra (emicizumab-kxwh) in People With Moderate or Mild Hemophilia A

Basel, 11 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new pivotal data on its CD20xCD3 T-cell engaging bispecific antibody, mosunetuzumab, will be presented for the first time at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition from 11-14 December 2021.

Roche presents pivotal data at ASH 2021 for novel cancer immunotherapy mosunetuzumab

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new pivotal data on its CD20xCD3 T-cell engaging bispecific antibody, mosunetuzumab, will be presented for the first time at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition from December 11-14, 2021. Emerging data continue to show the promising benefit-risk profile of mosunetuzumab in relapsed or refractory (R/R) follicular lymphom

Genentech Presents Pivotal Data at ASH 2021 for Novel Cancer Immunotherapy Mosunetuzumab

Roche Holdings AG (OTC: RHHBY) reported follow-up efficacy, safety, and patient-reported outcomes data from the Phase 2 CITYSCAPE trial of tiragolumab plus Tecentriq as an initial treatment for PD-L1-positive metastatic non-small cell lung cancer.  After 2.5 years median follow-up, tiragolumab/Tecentriq combo regime continued to show an improvement in the intention-to-treat (ITT) population (n=67).

Roche Posts Encouraging Follow-up Data From Tiragolumab/Tecentriq Trial In Lung Cancer

Basel, 10 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new follow-up efficacy, safety and patient-reported outcomes (PROs) data from the phase II CITYSCAPE trial, investigating the novel anti-TIGIT cancer immunotherapy tiragolumab plus Tecentriq® (atezolizumab) compared with Tecentriq alone as an initial (first-line) treatment for people with PD-L1-positive metastatic non-small cell lung cancer (NSCLC). The full results are being featured as an oral presentation in the Proffered Paper session 2 (Abstract LBA2) at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2021, taking place 8-11 December.1 “These encouraging results suggest that combining anti-TIGIT and anti-PD-L1 cancer immunotherapies such as tiragolumab and Tecentriq could potentially represent a novel approach to address unmet needs in cancer,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “With tiragolumab, we have the largest and most advanced anti-TIGIT clinical programme, and we look forward to the results of our phase III trials in lung cancer and other challenging tumour types.” After 2.5 years median follow-up, tiragolumab plus Tecentriq continued to show an improvement in the intention-to-treat (ITT) population (n=67), driven by the PD-L1-high population (TPS ≥ 50%) (n=29). In the ITT population, the combination reduced the risk of disease worsening or death (progression-free survival; PFS) by 38% (median PFS=5.6 vs. 3.9 months; hazard ratio (HR)=0.62, 95% CI: 0.42-0.91) and improved overall response rates (ORR) (38.8% vs. 20.6%) compared with Tecentriq alone. A predefined exploratory analysis in the PD-L1-high population showed a 71% reduction in the risk of disease worsening or death (median PFS=16.6 vs. 4.1 months; HR=0.29, 95% CI: 0.15-0.53) and a clinically meaningful improvement in ORR (69% vs. 24.1%) with the combination compared with Tecentriq alone.1 The analysis also showed that tiragolumab plus Tecentriq improved overall survival (OS), a secondary endpoint of the study, in the ITT population, which was driven by the PD-L1-high population. After 2.5 years median follow-up, median OS was 23.2 vs. 14.5 months (HR=0.69, 95% CI: 0.44-1.07) in the ITT population. The exploratory data in the PD-L1-high population showed a clinically meaningful OS improvement. The median was not reached for the tiragolumab regimen and is projected to be greater than 30.3 months based on the lower confidence interval (NE (30.3-NE) vs. 12.8 months (4.7-24.2); HR=0.23, 95% CI: 0.10-0.53).1 Data suggest that the combination was generally well-tolerated, showing similar rates of Grade 3-4 treatment-related adverse events (AEs) when adding tiragolumab to Tecentriq compared with Tecentriq alone (22.4% vs. 25%). The most common all cause AEs (rate greater than 5% difference between study groups) seen with the combination were infusion-related reactions, stiffness, dry skin, fatigue and rash. After longer follow-up, no new safety signals were observed with the combination. Patients generally reported minimal-to-moderate symptoms and generally maintained their quality of life compared with the start of treatment. PRO data from this exploratory analysis showed that lung symptoms, such as dyspnoea and pain, did not appear to deteriorate with the addition of tiragolumab to Tecentriq.1 CITYSCAPE study forms the basis of an industry-leading development programme across multiple settings and tumour types.3 The phase III SKYSCRAPER-01 trial is currently ongoing to confirm these results in the PD-L1-high population, with the goal of bringing this treatment option to patients. Earlier this year, tiragolumab was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration – representing the first anti-TIGIT therapy to be granted this designation and the 37th BTD for Roche's portfolio of medicines. Since 2020, Roche has initiated five phase III trials evaluating tiragolumab plus Tecentriq in early and metastatic disease in lung (SKYSCRAPER-01, SKYSCRAPER-02, SKYSCRAPER-03) and oesophageal cancers (SKYSCRAPER-07, SKYSCRAPER-08). Tiragolumab is also being evaluated in other solid tumours as well as in haematological cancers. About the CITYSCAPE study 1 CITYSCAPE is a global phase II, randomised and blinded study evaluating tiragolumab plus Tecentriq® (atezolizumab) compared with Tecentriq alone in 135 patients with first-line PD-L1-positive locally advanced, unresectable or metastatic non-small cell lung cancer. Patients were randomised 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until progressive disease or loss of clinical benefit. Co-primary endpoints are overall response rate (ORR) and progression-free survival (PFS). Secondary endpoints include safety, overall survival (OS) and patient-reported outcomes (PROs). PRO results were assessed with EORTC QLQ-C30, a questionnaire developed to assess the quality of life of people with cancer, administered at baseline and throughout study treatment. A summary of the results are as follows:

New data from the phase II CITYSCAPE trial show encouraging results with Roche's novel anti-TIGIT tiragolumab plus Tecentriq

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new follow-up efficacy, safety and patient-reported outcomes (PROs) data from the Phase II CITYSCAPE trial, investigating the novel anti-TIGIT cancer immunotherapy tiragolumab plus Tecentriq® (atezolizumab) compared with Tecentriq alone as an initial (first-line) treatment for people with PD-L1-positive metastatic non-small cell lung cancer (NSCLC). The full results

New Data From the Phase II CITYSCAPE Trial Show Encouraging Results With Genentech's Novel Anti-TIGIT Tiragolumab Plus Tecentriq

Affimed

Affimed (AFMD) starts recruiting patients in a phase I/IIa study to evaluate the combination of AFM24 and Roche's atezolizumab in solid tumors.

Affimed (AFMD) Starts AFM24-102 Study With Roche's Tecentriq

Recursion (RXRX) inks a collaboration with Roche to identify novel targets and advance medicines in areas of neuroscience and oncology indication. Shares rise.

Recursion (RXRX) Inks Neuroscience and Oncology Deal With Roche

The CHMP recommends EU approval for Roche's (RHHBY) Actemra to treat patients with severe COVID-19.

Roche (RHHBY) Actemra Gets CHMP Recommendation for COVID-19

Recursion Pharmaceuticals

SALT LAKE CITY, Dec. 7, 2021 /PRNewswire/ -- Recursion (NASDAQ: RXRX), a clinical-stage biotechnology company decoding biology to radically improve lives by industrializing drug discovery, development and beyond through disruptive innovation, today announced a transformational collaboration with Roche (SIX: RO, ROG; OTCQX: RHHBY) and Genentech, a member of the Roche Group. Recursion will work with both Roche and Genentech's R&D units to leverage technology-enabled drug discovery through the Recursion Operating System (OS) to more rapidly identify novel targets and advance medicines in key areas of neuroscience as well as in an oncology indication.

Recursion Announces Transformational Collaboration with Roche and Genentech in Neuroscience and Oncology, Advancing Novel Medicines to Patients Using Machine Learning and High Content Screening Methods at Scale to Map Complex Biology

The European Commission has extended the marketing authorization for Roche Holdings AG's (OTC: RHHBY) Actemra/RoActemra (Tocilizumab) to treat patients with severe COVID-19. The drug can now be administered in adults with COVID-19 who receive systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

News for Roche Holding AG Stock (RHHBY)