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.

The FDA has granted priority review for Genentech's, a unit of Roche Holdings AG (OTC: RHHBY) supplemental marketing application for Evrysdi (risdiplam) to treat pre-symptomatic babies under two months of age with spinal muscular atrophy (SMA).  Evrysdi is already approved to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older.

Genentech's Evrysdi Application Under FDA Priority Review For Use In Babies Below 2 Months

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Basel, 25 January 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of a supplemental new drug application (sNDA) for the use of Evrysdi® (risdiplam) to treat pre-symptomatic babies under two months of age with spinal muscular atrophy (SMA). The sNDA submission incorporates interim data from the RAINBOWFISH study, which shows the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting, standing, walking and maintained the ability to swallow following 12 months of treatment.  “Treating very young babies with Evrysdi before SMA symptoms arise may help them to achieve milestones such as standing and walking within timeframes typical of healthy infants,” said Levi Garraway, M.D., Ph. D., Roche's Chief Medical Officer and Head of Global Product Development. “Extending treatment access for the youngest members of the SMA community is crucial and we look forward to working with the FDA on this application.” Evrysdi is designed to treat SMA by increasing and sustaining production of the survival motor neuron (SMN) protein in the central nervous system (CNS) and peripheral tissues. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement. Evrysdi's existing FDA label is for the treatment of SMA in adults, children and babies two months and older. If approved, Evrysdi would be the first medicine administered at-home for pre-symptomatic babies with SMA.  Initial interim data from the RAINBOWFISH study, presented at the World Muscle Society (WMS) Virtual Congress 2021, showed that of the babies included in the interim efficacy analysis, all (5/5), maintained the ability to swallow and were able to feed exclusively orally after 12 months of treatment. Eighty per cent (4/5) treated with Evrysdi for at least 12 months achieved milestones such as standing and walking independently within World Health Organization windows for healthy children. All participants (n=5) met HINE-2* motor milestones of head control, sitting upright, rolling and crawling after 12 months of treatment with Evrysdi.  No treatment related serious adverse events were reported in any of the babies treated with Evrysdi through the interim safety analysis period (n=12). Four treatment emergent adverse events were reported, and all were resolved or were resolving with ongoing treatment with Evrysdi. The most common adverse events (AEs) were nasal congestion (33%), cough (25%), teething (25%), vomiting (25%), eczema (17%), abdominal pain (17%), diarrhoea (17%), gastroenteritis (17%), papule (17%) and pyrexia (17%). The AEs were reflective of the age of the babies rather than the underlying SMA. The RAINBOWFISH study is currently recruiting. The latest results from the RAINBOWFISH study will be presented at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference in March 2022.  Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. *Hammersmith Infant Neurological Examination, Section 2 About Evrysdi ® ( risdiplam ) Evrysdi is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube.  Evrysdi is designed to treat SMA by increasing and sustaining the production of the survival motor neuron (SMN) protein in the central nervous system (CNS) and peripheral tissues. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement.  Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by the U.S Food and Drug Administration in 2017. In 2021 Evrysdi was awarded Drug Discovery of the Year by the British Pharmacological Society as well as the Society for Medicines Research award for Drug Discovery. Evrysdi is currently approved in 70 countries and the dossier is under review in a further 31 countries.  Evrysdi is currently being evaluated in five multicentre trials in people with SMA:

Roche's Evrysdi (risdiplam) granted FDA priority review for treatment of pre-symptomatic babies under 2 months of age with spinal muscular atrophy (SMA)

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 granted priority review of a supplemental new drug application (sNDA) for the use of Evrysdi® (risdiplam) to treat pre-symptomatic babies under two months of age with spinal muscular atrophy (SMA). The sNDA submission incorporates interim data from the RAINBOWFISH study, which shows the majority of pre-symptomatic

Genentech's Evrysdi (risdiplam) Granted FDA Priority Review for Treatment of Pre-Symptomatic Babies Under 2 Months of Age With Spinal Muscular Atrophy (SMA)

Basel, 24 January 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that The Lancet has published two papers highlighting one-year results from four pivotal phase III studies of faricimab, an investigational bispecific antibody, in neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). [1,2] All four studies – which enrolled more than 3,000 people in total – met their primary endpoints, showing that people treated with faricimab up to every four months achieved non-inferior vision gains compared to aflibercept given every two months. Notably, about half of eligible faricimab patients were able to go four months between treatments in the first year, and approximately three-quarters could go three months or longer in the TENAYA and LUCERNE nAMD studies and the YOSEMITE and RHINE DME studies. [1,2] The current standard of care for these potentially blinding conditions requires eye injections as often as once a month [3,4]. “These data published in The Lancet reinforce the potential of faricimab as an important treatment option that may help improve and maintain vision while extending the time between treatments up to four months,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We remain deeply committed to developing new medicines such as faricimab that may help preserve sight in many people living with serious retinal conditions.” If approved, faricimab would be the first bispecific antibody for the eye, targeting and inhibiting two distinct pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). [5] Inhibition of both pathways has been shown to have potentially complementary benefits, stabilising vessels and thereby reducing vessel leakage and inflammation more than inhibition of the VEGF-A pathway alone. [6] Key Findings [1,2]In the TENAYA and LUCERNE studies in nAMD, the average vision gains from baseline at one-year in the faricimab arms were +5.8 and +6.6 letters, respectively, compared to +5.1 and +6.6 letters in the aflibercept arms. The studies also measured the proportion of people in the faricimab arm that were treated on dosing schedules of every three or four months during the first year. Importantly, 46% (n=144/315) of patients in TENAYA and 45% (n=142/316) in LUCERNE were able to be treated every four months in the first year. An additional 34% (n=107/315) of patients in TENAYA and 33% (n=104/316) in LUCERNE were able to be treated every three months. Combined, nearly 80% of faricimab-treated patients were able to go three months or longer between treatments during the first year. Consistent with vision outcomes, faricimab treatment resulted in a meaningful and comparable reduction in central subfield thickness (CST) and comparable decreases in choroidal neovascularisation lesion size and area. Faricimab was generally well-tolerated in both studies, with a favourable benefit-risk profile. Ocular adverse events (AEs) were comparable across treatment arms and consistent with those expected with intravitreal anti-VEGF injections in patients with nAMD. In the YOSEMITE and RHINE studies in DME, the average vision gains from baseline at one-year were +11.6 and +10.8 eye chart letters in the faricimab treat-and-extend arms, +10.7 and +11.8 letters in the two-month arms and +10.9 and +10.3 letters in the aflibercept arms, respectively. A secondary endpoint in both studies measured the proportion of people in the faricimab treat-and-extend arms that achieved dosing schedules of every three or four months at the end of the first year. Importantly, 53% (n=151/286) of faricimab treat-and-extend patients in YOSEMITE and 51% (n=157/308) in RHINE achieved four-month dosing at one-year. An additional 21% (n=60/286) of faricimab treat-and-extend patients in YOSEMITE and 20% (n=62/308) in RHINE achieved three-month dosing. Combined, more than 70% of faricimab treat-and-extend patients were able to go three months or longer between treatments at the end of the first year. Reductions in CST and resolution of intraretinal fluid through the first year consistently favoured faricimab over aflibercept. Faricimab was generally well-tolerated in both studies, with a favourable benefit-risk profile. Ocular AEs were comparable across treatment arms and consistent with those expected with intravitreal anti-VEGF injections in patients with DME. Faricimab is currently under review by the U.S. Food and Drug Administration for the treatment of nAMD and DME. The European Medicines Agency is also currently evaluating the faricimab Marketing Authorisation Application for the treatment of nAMD and DME. Additionally, the COMINO and BALATON trials are underway, evaluating the efficacy and safety of faricimab in people with macular edema following retinal vein occlusion. [7,8] Two-year results for faricimab in DME will be presented at the Angiogenesis, Exudation, and Degeneration 2022 meeting, on Saturday 12 February. About the TENAYA and LUCERNE studies [1]TENAYA (NCT03823287) and LUCERNE (NCT03823300) are two identical, randomised, multicentre, double-masked, global phase III studies, evaluating the efficacy and safety of faricimab compared to aflibercept in 1,329 people living with neovascular or “wet” age-related macular degeneration (671 in TENAYA and 658 in LUCERNE). The studies each have two treatment arms: faricimab 6.0 mg administered at fixed intervals of every two, three, or four months, selected based on objective assessment of disease activity at weeks 20 and 24; aflibercept 2.0 mg administered at fixed two-month intervals. In both arms, sham injections were administered at study visits when treatment injections were not scheduled, to maintain the masking of investigators and participants. The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline averaged over weeks 40, 44 and 48. Secondary endpoints include: safety; the percentage of participants in the faricimab arm receiving treatment every two, three and four months; the percentage of participants achieving a gain, and the percentage avoiding a loss, of 15 letters or more in BCVA from baseline over time; change in central subfield thickness from baseline over time; and change in total area of choroidal neovascularization lesion and leakage from baseline over time. About the YOSEMITE and RHINE studies [2]YOSEMITE (NCT03622580) and RHINE (NCT03622593) are two identical, randomised, multicentre, double-masked, global phase III studies evaluating the efficacy and safety of faricimab compared to aflibercept in 1,891 people with diabetic macular edema (940 in YOSEMITE and 951 in RHINE). The studies each have three treatment arms: faricimab 6.0 mg administered at intervals of up to every four months using a treat and extend approach, after four initial monthly doses; faricimab 6.0 mg administered at fixed two-month intervals after six initial monthly doses; and aflibercept administered at fixed two-month intervals after five initial monthly doses. In all three arms, sham injections were administered at study visits when treatment injections were not scheduled, to maintain the masking of investigators and participants. The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score from baseline at one-year. Secondary endpoints include: safety; the percentage of participants in the treat and extend arm receiving faricimab every one, two, three and four months, at week 52; the percentage of participants achieving a two-step or greater improvement from baseline in diabetic retinopathy severity at week 52; the percentage of participants achieving a gain, and the percentage avoiding a loss, of 15 letters or more in BCVA from baseline over time; change in central subfield thickness from baseline over time; and percentage of patients with absence of intraretinal fluid over time. About neovascular age-related macular degeneration Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading. [9,10] Neovascular or “wet” AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss. [11,12] It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis. [12] Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages. [9,13,14] About diabetic macular edema Affecting around 21 million people globally, diabetic macular edema (DME) is a vision-threatening complication of diabetic retinopathy (DR). [15] DME occurs when the damaged blood vessels leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving. [10,16] The number of people with DME is expected to grow as the prevalence of diabetes increases. [17] The condition is associated with blindness when left untreated and decreased quality of life. [18] There remains a significant unmet need for more effective, longer-lasting therapies for people with DME. [6] About faricimab [5]Faricimab is the first investigational bispecific antibody designed for the eye. It targets two distinct pathways linked to a number of vision threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking both pathways involving Ang-2 and VEGF-A, faricimab is designed to stabilise blood vessels, potentially improving vision outcomes for longer for people living with retinal conditions. About Roche in Ophthalmology Roche is focused on saving people's eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients.

The Lancet publishes studies showing Roche's faricimab improved and maintained vision in two leading causes of vision loss, extending time between treatments up to four months

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced The Lancet has published two papers highlighting one-year results from four pivotal Phase III studies of faricimab, an investigational bispecific antibody, in wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). All four studies – which enrolled more than 3,000 people in total – met their primary endpoints, showing that patie

The Lancet Publishes Studies Showing Genentech's Faricimab Improved and Maintained Vision in Two Leading Causes of Vision Loss, Extending Time Between Treatments up to Four Months

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Roche launches the cobas ® pulse system, an industry first professional blood glucose management solution with mobile digital health capabilities to improve patient care

Roche launches the cobas® pulse system, an industry first professional blood glucose management solution with mobile digital health capabilities to improve patient care

Basel, 11 January 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today introduced cobas® infinity edge, a secure and encrypted cloud-based platform for the integration and management of point of care data, available for use in clinical settings globally. More people are using digital technologies in health than ever before. Only 15% of healthcare organisations are fully equipped to make quick data-driven decisions due to lack of data integration, multiple incompatible IT systems, and other information silos. With longer life expectancies, and more people living with chronic conditions, healthcare systems face growing pressure to manage more patient data and diagnostic information. Digital health ecosystems can help address these challenges. The cobas® infinity edge platform supports healthcare professionals in overcoming these challenges by bringing multiple capabilities together in one digital health ecosystem. Using applications, it facilitates professionals' ability to view and manage patient test results compliantly, while allowing the integration of this data into patients' electronic medical records (EMRs). It allows deploying new applications in a point of care device, such as the cobas® pulse glucose meter, and connecting patient health information from this device in an easy, timely, secure way to various IT systems. Concurrently, it allows health professionals to access a marketplace of medically relevant applications to drive adoption of digital tools that improve patient care, by leveraging Roche's network of third party developers. Bringing all of these capabilities together, it breaks down information silos, ultimately driving improved patient care and operational efficiency within and across point of care clinical settings and hospital departments. “Roche is pioneering digital innovations to solve operational and clinical challenges in healthcare,” says Thomas Schinecker, CEO Roche Diagnostics. “With cobas® infinity edge, we are introducing the infrastructure for a digital ecosystem in point of care. We have combined our ability to connect health data safely, securely and compliantly plus our deep healthcare expertise with a unique marketplace, where professionals can use Roche or third-party digital health solutions. We can accelerate digital adoption in healthcare and deliver access to health information anytime, anywhere, for improving patient care.” The cobas® infinity edge solution suite is compliant with ISO27001, the international standard for information security for cloud-based products and compliant with GDPR and HIPAA data privacy regulations. Its digital ecosystem includes technologies to solve specific operational challenges in lab and hospital settings as well as a digital marketplace offering health-relevant applications from Roche and third-party innovative developers. Following first commercial availability in select markets, Roche Diagnostics plans to offer the new digital platform in other markets globally throughout 2022 and 2023. About cobas ® infinity edge suite of solutions The Roche software solution suite called cobas® infinity edge includes three modules: unite, scribe, and smart. Used together, the solution facilitates the ability of labs and hospitals to manage patient-testing devices (Roche and non-Roche) that measure clinical health parameters anytime, anywhere. cobas® infinity edge also enables the deployment of third party applications into point of care devices. With this digital ecosystem approach, lab and hospital administrators can also better govern, update and manage use of near-patient testing devices - even remotely. The platform uses industry standard security technologies and processes to connect to electronic medical record systems (EMRs) as well as enabling remote installations, service and maintenance of devices outside the lab/hospital premises (e.g., clinics or pharmacies). This solution will bring more diagnostic capabilities - safely and securely - beyond the lab walls - closer to physicians and nurses at the points where clinical decisions are being made. About Roche Diagnostics in digital health With growing investments in digital capabilities, Roche is building on its expertise in science, medicine and technology to increasingly leverage data analytic tools and novel digital technologies to transform the way healthcare is delivered and managed for each patient. Our data-driven digital solutions empower labs, healthcare providers and patients to make informed, insights-based decisions across the entire care continuum – reducing costs to society and improving patient health outcomes in the process. 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 introduces cobas infinity edge, a new open digital ecosystem for point of care professionals, driving improved patient outcomes and operational efficiencies in healthcare

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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.

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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

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