Updated data from the pivotal Phase III STARGLO study continue to demonstrate a clinically meaningful improvement in overall survival with a 40% survival benefit for people with R/R DLBCL who are not candidates for transplant 89% of patients whose cancer had fully responded at the end of treatment with Columvi in combination with chemotherapy were still alive and 82% showed no signs of cancer one year post-treatment Timely... Read More

Susvimo can help people with diabetic retinopathy (DR) maintain their vision and prevent progression to blindness with only one treatment every nine months Susvimo’s innovative technology via the Port Delivery Platform may offer an alternative to regular eye injections in the US Diabetic retinopathy affects almost 10 million people in the US and is the third FDA-approved indication for Susvimo, which is also approved for... Read More

Columvi is the first bispecific antibody to show a statistically significant and clinically meaningful 41% survival benefit in R/R DLBCL in the Phase III STARGLO study There is an urgent need for effective, immediately available therapies that are broadly accessible to people with transplant-ineligible R/R DLBCL This first-of-its-kind Columvi combination could provide a much-needed, off-the-shelf and fixed-duration treatment... Read More

Long term follow-up in this curative setting demonstrated clinically meaningful survival benefit when adding adjuvant Perjeta ® (pertuzumab) to Herceptin ® (trastuzumab) and chemotherapy 21% reduction in the risk of death was seen in the pre-specified subgroup of people with lymph node-positive disease Data to be presented as a late-breaking abstract at the 2025 European Society for Medical Oncology (ESMO) Breast Cancer... Read More

An investment of up to $550 million by 2030 will establish the Indianapolis site as a hub for manufacturing of Roche's continuous glucose monitoring solution. Expansion will create hundreds of jobs while also enhancing U.S. production capabilities. Increased access to diabetes management tools will help improve health outcomes for patients in the U.S. and globally. INDIANAPOLIS , May 12, 2025 /PRNewswire/ -- Roche (SIX: RO,... Read More

Future 700,000 sq. ft. facility in Holly Springs, NC, will support pharma division’s metabolic medicines portfolio $700+ million investment will add 400+ high-wage manufacturing and 1,500+ construction jobs in North Carolina Initial planned investment could expand in the future based on business needs and the U.S. policy environment State-of-the-art addition will represent Genentech’s first East Coast manufacturing facility... Read More

Detailed results from the CENTERSTONE trial show treatment with Xofluza reduced the odds of transmission, or spread of influenza virus, from an infected person to household members by 32% CENTERSTONE is the first global phase III trial that demonstrates the benefit of an antiviral in reducing the spread of a respiratory virus Reducing the spread of infection within households could help limit transmission within institutions... Read More

New trontinemab data continue to support rapid and deep, dose-dependent reduction of amyloid plaques in Phase Ib/IIa Brainshuttle™ AD study Data on the Elecsys ® pTau181 plasma test demonstrate potential to accurately rule out amyloid pathology, one of the hallmarks of Alzheimer’s disease A Phase III program for trontinemab later this year will be initiated based on totality of data SOUTH SAN FRANCISCO, Calif. / Apr 03, 2025... Read More

MUSETTE trial was designed to determine whether a higher dose of the currently approved Ocrevus IV 600 mg would provide additional benefit to people living with relapsing multiple sclerosis The trial did not meet its primary endpoint; results support Ocrevus IV 600 mg as the optimal dose to slow disability progression High dose was well tolerated with an overall comparable safety profile to Ocrevus IV 600 mg and no new... Read More

Agreement allows for a range of potentially best-in-class therapy options as monotherapy and fixed dose combination with Roche`s lead incretin asset CT 388 Collaboration will complement Roche's portfolio in the field of cardiovascular, renal, and metabolic (CVRM) diseases Obesity is a heterogeneous disease with over 200 related comorbidities, including cardiovascular and metabolic diseases, and is expected to impact over 4... Read More

Gazyva is the only anti-CD20 monoclonal antibody in a randomized Phase III study to demonstrate a complete renal response benefit The filing application is based on data from the Phase III REGENCY study, where Gazyva showed superiority over standard therapy alone in people with active lupus nephritis Lupus nephritis affects 1.7 million people worldwide; up to one-third of people on current treatments will progress to... Read More

TNKase ® (tenecteplase) is the first stroke medicine approved by the FDA in nearly 30 years Single five-second intravenous bolus provides faster and simpler administration than the approved standard-of-care Genentech has developed the only two FDA-approved medicines to treat acute ischemic stroke, TNKase and Activase ® (alteplase) SOUTH SAN FRANCISCO, Calif. / Mar 03, 2025 / Business Wire / Genentech, a member of the Roche... Read More

First-ever head-to-head trial comparing Xolair and oral immunotherapy (OIT) Results were featured as late-breakers at the 2025 AAAAI Annual Meeting Xolair is the only U.S. FDA-approved medicine to reduce allergic reactions in children and adults with one or more food allergies SOUTH SAN FRANCISCO, Calif. / Mar 02, 2025 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new... Read More

Roche's innovative sequencing by expansion (SBX) technology represents a leap forward in next-generation sequencing (NGS), which is playing a vital role in decoding complex diseases like cancer, immune disorders and neurodegenerative conditions Combined with an innovative, high throughput sensor module, SBX uses expanded synthetic molecules to determine the DNA sequence of a target molecule, creating an ultra-rapid, scalable... Read More

Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution New tablet formulation may provide greater freedom and independence for people with SMA thanks to simplified dose administration SOUTH SAN FRANCISCO, Calif. / Feb 12, 2025 / Business... Read More

Nearly half of patients on Gazyva plus standard therapy achieved a complete renal response (CRR), with a statistically significant and clinically meaningful improvement, compared to standard treatment alone Analysis showed consistent CRR benefit across patient subgroups highlighting potential to treat a broad patient population with high unmet need Gazyva is the only anti-CD20 monoclonal antibody in a phase III study to... Read More

Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME) With as few as two treatments per year, Susvimo may help people with DME maintain their vision Approval marks the second indication for Susvimo in addition to wet, or neovascular age-related macular degeneration (AMD) SOUTH SAN FRANCISCO, Calif. / Feb 04, 2025 / Business Wire... Read More

Updated overall survival (OS) results – a key secondary endpoint – reinforce the significant benefit of the Itovebi TM (inavolisib)-based regimen for patients with advanced PIK3CA-mutated, HR-positive, HER2-negative breast cancer in the first-line setting Primary analysis showed the Itovebi-based regimen reached statistical significance, more than doubling progression-free survival in this patient population Full OS results... Read More

The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes. 1,2 The test helps differentiate a B-cell cancer from a normal, reactive immune response, offering diagnostic certainty... Read More

The VENTANA DP 600 slide scanner, part of Roche's Digital Pathology Dx system, is now cleared by the FDA to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. This 240-slide scanner produces excellent image quality of stained histology slides from patient tissue samples, while providing ease-of-use and workflow flexibility for the pathology lab. Primary diagnosis in digital pathology... Read More

Basel, 8 January 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Roche’s wholly owned subsidiary Blue Giant Acquisition Corp. has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of Poseida Therapeutics, Inc. (“Poseida”, NASDAQ: PSTX) at a price of $9.00 per share in cash, plus a non-tradeable contingent value... Read More

PADOVA study showed numerical delay in motor progression and positive trends on multiple secondary and exploratory endpoints Prasinezumab continues to be well tolerated and no new safety signals were observed Genentech is further evaluating the data and will work together with health authorities to determine next steps SOUTH SAN FRANCISCO, Calif. / Dec 19, 2024 / Business Wire / Genentech, a member of the Roche Group (SIX:... Read More

Long-term data confirm fixed-duration Columvi and Lunsumio achieve durable remissions beyond the end of treatment, with real-world data suggesting reduced treatment-related travel burden due to less frequent dosing First presentation of Lunsumio given subcutaneously showed non-inferiority to intravenous treatment with a consistent safety profile, potentially providing an additional outpatient option with a shorter... Read More

Exploratory long-term follow-up analysis of the Phase III POLARIX study indicated a positive trend in overall survival in favor of Polivy in combination with R-CHP for people with first-line diffuse large B-cell lymphoma (DLBCL) Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, potentially reducing burdens on patients and healthcare systems These encouraging five-year results... Read More

Application is based on data from the Phase III STARGLO study where Columvi plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival This regimen could provide an off-the-shelf, fixed-duration treatment option for patients to start soon after diagnosis, which is important for those who are at high-risk of disease progression Improving survival outcomes is needed for... Read More

Acquisition supports Roche’s Pharma Strategy and allows for a range of potentially first and best-in-class therapies across oncology, immunology, and neurology, uniquely positioning Roche in the new field of donor-derived off-the-shelf cell therapies Roche to acquire Poseida Therapeutics fo r US $9.00 per share in cash at closing, representing a total equity value of approximately US $1.0 billion Stockholders would also... Read More

Basel, 26 November 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) reports an update on the phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq® (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC). SKYSCRAPER-01 is a global phase III, randomised, double-blind study evaluating tiragolumab plus Tecentriq compared to... Read More

SOUTH SAN FRANCISCO, Calif. / Nov 26, 2024 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reports an update on the Phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq ® (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC). SKYSCRAPER-01 is a global Phase III, randomized,... Read More

The PATHWAY HER2 (4B5) test helps to identify patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA. There are currently very few options for BTC patients as most cases are at an advanced stage at the time of diagnosis. This approval... Read More

The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay detects the folate receptor 1 protein (FOLR1 or FRɑ), which is over-expressed in most ovarian cancers. The test identifies ovarian cancer patients eligible for targeted treatment with ELAHERE. This certification follows the unprecedented decision by regulators to grant an early exemption approval for the test in Germany and Austria earlier this year. TUCSON, Ariz. , Nov. 18, 2024... Read More

Collaboration will leverage Flare Therapeutics' proteomic and mass spectrometry platform and expertise, powered by its proprietary library of electrophilic compounds, to discover novel small molecules aimed at transcription factor targets in oncology Flare Therapeutics to receive US$70 million upfront, and potential milestone payments exceeding US$1.8 billion , as well as royalties CAMBRIDGE, Mass. , Nov. 12, 2024... Read More

SOUTH SAN FRANCISCO, Calif. / Nov 05, 2024 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will present more than 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 7-10, 2024 in San Diego, California. The data underscore Genentech’s commitment to advance patient outcomes in... Read More

Itovebi TM (inavolisib)-based regimen demonstrated a statistically significant and clinically meaningful benefit, reducing the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the INAVO120 study The U.S. FDA recently approved the Itovebi-based regimen as a first-line treatment for people with HR-positive, HER2-negative breast cancer with a PIK3CA mutation, one of the most commonly... Read More

The ELEVATUM study showed clinically meaningful improvement in vision and reduction in retinal fluid in people with DME treated with Vabysmo who identify as African American, Black, Hispanic and Latino Efficacy and safety from this Phase IV study were consistent with data from the Vabysmo Phase III DME studies These racial and ethnic groups are disproportionately affected by diabetes and at higher risk of developing DME, a... Read More

The new VENTANA CLDN18 (43-14A) RxDx Assay helps fulfil an unmet medical need by enabling clinicians to identify patients with gastric or gastroesophageal junction (GEJ) cancer who may benefit from a targeted treatment option. CLDN18.2 is an emerging biomarker in gastric and GEJ cancers and helps predict the likelihood of response to targeted therapy. As the leader in companion diagnostics, Roche continues to build on its... Read More

Positive data confirm Evrysdi efficacy and safety in children first treated pre-symptomatically before 6 weeks of age, with most achieving motor milestones similar to children without SMA All children were able to swallow and feed orally, with none requiring permanent ventilation Evrysdi is the only non-invasive SMA therapy and is approved in over 100 countries, with more than 16,000 people with SMA treated globally SOUTH... Read More

Approval is based on Phase III INAVO120 results, showing the Itovebi TM (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting This approval helps address an urgent unmet need in breast cancer for people with a PIK3CA mutation, one of the most commonly mutated genes in HR-positive disease, associated with poor prognosis Itovebi is... Read More

Survey findings from over 8,700 people in 12 countries show that half of those polled have inadequate understanding of HPV, with nearly one-third being unsure or unaware of it altogether. 1 Findings also show that significant barriers continue to exist that are preventing women from seeking screening. 1 However, more than 70% of the respondents indicated they would be interested in the option of collecting their own sample... Read More

The REGENCY study met its primary endpoint, demonstrating statistically significant and clinically meaningful treatment benefits in people with active lupus nephritis Gazyva is designed to target an underlying cause of lupus nephritis, aiming to prevent or delay progression to end-stage kidney disease Lupus nephritis is a potentially life-threatening manifestation of an autoimmune disease affecting 1.7 million people... Read More

Data from the CENTERSTONE study shows single-dose Xofluza reduces transmission of influenza from an infected person to household members This is the first time that any antiviral used in the treatment of a respiratory viral illness has demonstrated a transmission reduction benefit in a global Phase III study Reducing the spread of infection in the household could help limit transmission within communities and societies,... Read More

Ocrevus Zunovo™ has the potential to expand treatment options to centers without IV infrastructure or with IV constraints, like at a doctor's office This approval is backed by a decade of proven safety and efficacy data of Ocrevus ® IV, with over 350,000 people treated globally Ocrevus Zunovo™ offers people with multiple sclerosis (MS) more options to access treatment based on their individual needs SOUTH SAN FRANCISCO,... Read More

Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous (IV) Tecentriq New subcutaneous (SC) option reduces treatment time to approximately 7 minutes, compared with 30-60 minutes for IV infusion SOUTH SAN FRANCISCO, Calif. / Sep 12, 2024 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),... Read More

The Roche Digital Pathology Open Environment brings together a wide array of innovative AI-based pathology tools to help clinicians improve patient care and expand personalised healthcare. Roche is now integrating more than 20 artificial intelligence (AI) algorithms from eight new collaborators into its digital pathology open environment. AI technology helps enhance pathology with high value insights, which can benefit... Read More

Two-year Phase III data presented at ASRS 2024 show Susvimo’s potential as an alternative to eye injections to treat diabetic macular edema (DME) and diabetic retinopathy (DR) Safety data were consistent with the known safety profile for Susvimo in people with DME and DR Additionally, the FDA has accepted the filing application for Susvimo in DME and DR based on one-year Pagoda and Pavilion study data Susvimo is a unique... Read More

More than 90% of patients had absence of DME after four years in a pre-specified exploratory endpoint People treated with Vabysmo sustained vision gains and anatomical improvements, with almost 80% receiving treatment at intervals of three or four months, in an exploratory analysis The study met all primary endpoints, showing safety data were consistent with Vabysmo’s known safety profile This is the largest long-term... Read More

More than 90% of patients had absence of DME after four years in a pre-specified exploratory endpoint People treated with Vabysmo sustained vision gains and anatomical improvements, with almost 80% receiving treatment at intervals of three or four months, in an exploratory analysis The study met all primary endpoints showing safety data were consistent with Vabysmo's known safety profile This is the largest long-term... Read More

After four weeks of treatment, CT-996 demonstrated clinically meaningful weight loss of -7.3% (weight loss in placebo -1.2%; p < 0.001) 1 Pharmacokinetic data supports a once-daily oral dosing regimen for CT-996 1 The safety and tolerability profile was consistent with other oral GLP-1 receptor agonists and no unexpected safety signals were observed 1 SOUTH SAN FRANCISCO, Calif. / Jul 17, 2024 / Business Wire / Genentech, a... Read More

The collaboration leverages Remix's REMaster ™ platform to discover novel drugs for a diverse range of target classes Remix is eligible to receive up to $1 billion in milestone payments and royalties WATERTOWN, Mass. , July 10, 2024 /PRNewswire/ -- Remix Therapeutics (Remix), a clinical-stage biotechnology company developing small molecule therapies to modulate RNA processing and address underlying drivers of disease, today... Read More

The FDA has approved updates to Susvimo, which will be available to U.S. retina specialists and patients with wet AMD in the coming weeks Susvimo offers the first alternative to regular eye injections that are standard of care for wet AMD, which impacts 1.5 million people in the U.S. and 20 million people worldwide and can... Read More

Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness Designed to simplify administration, Vabysmo PFS provides retina specialists a ready-to-use option Vabysmo PFS will be available for people living with wet AMD, DME and RVO SOUTH SAN... Read More

SKYSCRAPER-06 evaluating tiragolumab plus Tecentriq and chemotherapy did not meet the primary endpoints of progression-free survival at primary analysis and overall survival at first interim analysis The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy compared to the comparator arm Safety was consistent with previous studies, however we intend to halt the trial due to reduced efficacy... Read More

The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes. 1,2 The test helps differentiate a B-cell cancer from a normal, reactive immune response, providing diagnostic certainty for healthcare providers and their patients. B-cell lymphoma accounts for approximately 85 percent... Read More

The solution, which includes the VENTANA DP 200 slide scanner, Roche's digital pathology workflow software and a display, is now cleared to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. Primary diagnosis for digital pathology enhances healthcare efficiency and helps ensure effective and timely patient care, especially in areas where access to pathologists is limited. This... Read More

The study met its primary endpoint of overall survival with a 41% reduction in the risk of death in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) treated with Columvi plus chemotherapy This Columvi combination could provide a much-needed off-the-shelf treatment option for people with transplant-ineligible R/R DLBCL Data were featured in the congress Press Briefing and presented today in the... Read More

After 5 years of treatment, 91% of children were alive — without treatment, children with Type 1 SMA would not be expected to live past 2 years of age 96% of Evrysdi-treated children could swallow, 80% could feed without a feeding tube and 59% could sit without support for at least 30 seconds Evrysdi is now approved in more than 100 countries with over 15,000 patients treated globally SOUTH SAN FRANCISCO, Calif. / Jun 07,... Read More

Priority Review recognizes the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options Additional analyses of INAVO120 will be presented in an oral abstract session at the 2024 American Society of Clinical Oncology Annual Meeting The target action date for the FDA decision is November 27, 2024 SOUTH SAN FRANCISCO, Calif. / May 29, 2024 / Business Wire / Genentech, a member... Read More

Renewed partnership combines best in class engineering capabilities with cutting edge science to accelerate the availability of new solutions for customers and patients worldwide Upcoming launches of the new cobas ® c703 & ISE neo units and cobas ® Mass Spec solution are testament to the partnership's dedication to continued innovation The new 10-year contract will focus on strengthening the partnership for continued... Read More

The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting Approximately 40% of people with HR-positive breast cancer have a PIK3CA mutation and often face poorer prognosis and resistance to endocrine treatment This is the 29th Breakthrough Therapy Designation for Genentech’s... Read More

Over 24 weeks, a once-weekly subcutaneous injection of CT-388 achieved a clinically meaningful and statistically significant mean placebo-adjusted weight loss of 18.8% (p < 0.001) At week 24, 100% of CT-388 treated participants achieved >5% weight loss, 70% achieved >15% and 45% achieved >20% weight loss In a subgroup with pre-diabetes at baseline, CT-388 treatment normalized glycemia in all patients, indicating its strong... Read More

More than half of all U.S. cervical cancer patients are underscreened 1 , which makes reducing barriers to sample collection and increasing access to screenings crucial to ultimately helping eliminate this deadly disease. Each year in the U.S., more than 13,000 patients are diagnosed with cervical cancer and approximately 4,000 die from this preventable disease, caused by HPV infection. 1 Roche’s human papillomavirus (HPV)... Read More

Approval based on Phase III ALINA study showing Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected non-small cell lung cancer (NSCLC) This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy The National Comprehensive... Read More

Results from the Phase III study showed that subcutaneous (SC) injection was consistent with IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeks The twice-yearly, 10-minute SC injection has the potential to expand the usage of Ocrevus to treatment centers without IV infrastructure or with IV capacity limitations U.S. FDA and EMA accepted filings based on... Read More

Columvi, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphoma Data from the STARGLO study will be submitted to health authorities and presented at an upcoming medical meeting SOUTH SAN FRANCISCO, Calif. / Apr 15, 2024 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),... Read More

The Elecsys® pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly and Company Once approved, the test will aid healthcare providers in identifying amyloid pathology, a key feature of Alzheimer’s disease Roche and Lilly believe the test could play an important role in improving access to early and accurate Alzheimer’s diagnosis Basel, 11 April 2024 - Roche (SIX: RO,... Read More

Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2. 1 Patients with HER2-low status may now be eligible for HER2-targeted treatment, which could significantly improve their outcome. 2 The VENTANA HER2 (4B5) test is the only approved companion diagnostic indicated as an aid in the assessment of HER2-low status in metastatic breast cancer patients. TUCSON, Ariz. , April 10, 2024... Read More

The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malaria Malaria is a serious and potentially fatal parasitic infection most commonly transmitted by mosquitoes that can also be spread through blood transfusion Roche is dedicated to saving patients’ lives through diagnostic solutions that aid in the protection of the global blood supply from infectious diseases Basel, 26 March... Read More

Roche introduces its suite of navify operational excellence solutions, including navify Analytics and navify Monitoring, for use in laboratories and point of care services navify Analytics provides operational insights to lab managers and point of care coordinators to manage workflows more efficiently, reduce costs, and improve productivity Insights from navify Analytics, combined with the real-time insights from navify... Read More

Detailed results from the NIH-sponsored Phase III OUtMATCH study showed treatment with Xolair increased the amount of peanuts, tree nuts, egg, milk and wheat that people as young as 1 year consumed without an allergic reaction The U.S. FDA recently approved Xolair as the first and only medicine for children and adults with one or more food allergies Allergic reactions can be life-threatening and it is estimated that... Read More

Approval is based on data from the NIH-sponsored Phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placebo More than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once... Read More

PathAI will exclusively work with Roche Tissue Diagnostics (RTD) to develop artificial intelligence (AI) digital pathology algorithms for RTD's companion diagnostics business. The image analysis algorithms will be deployed on Roche's navify Digital Pathology platform, allowing seamless integration into pathology laboratories worldwide. The collaboration between RTD and PathAI helps advance precision medicine by bringing... Read More

Vabysmo sustained robust drying of retinal fluid, often associated with distorted or blurry vision Up to 60% of people receiving Vabysmo were able to extend treatment intervals to three or four months apart Detailed results from two global Phase III RVO studies will be presented at Angiogenesis, Exudation, and Degeneration 2024 Vabysmo is approved in the U.S. for RVO, and in more than 90 countries around the world for people... Read More

Remix to leverage REMaster ™ platform to discover novel drugs for a diverse range of target classes Remix will receive $30 million upfront and is eligible to receive up to $12 million in near-term milestone payments and up to $1 billion in milestone payments and royalties WATERTOWN, Mass. , Jan. 3, 2024 /PRNewswire/ -- Remix Therapeutics (Remix), a clinical stage biotechnology company developing small molecule therapies to... Read More

The transformative point of care solution will complement Roche’s centralised diagnostics portfolio across Clinical Chemistry, Immunochemistry, Coagulation and Molecular, and across multiple disease areas LumiraDx’s technology integrates multiple Point of Care tests on a simple to use single instrument and brings more affordable and accessible testing to patients worldwide Under the terms of the agreement, R oche will pay a... Read More

If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure Interim analysis results from first-of-its-kind Phase III OUtMATCH study showed Xolair significantly increased the amount of peanut, milk, egg and cashew it took to cause an allergic reaction 17 million people in the U.S. have confirmed food allergies and more than 40% of children and more than half... Read More

Healthcare professionals greatly value navify Tumor Board for improving tumour board meeting experiences, offering a holistic view of data, facilitating multidisciplinary team collaboration and optimising care decisions navify POC Operations attains excellent ratings from health professionals for enhancing point-of-care device management to improve patient care navify Lab Operations' ability to consolidate and automate lab... Read More

Longer-term data from pivotal studies of fixed-duration Columvi and Lunsumio continue to show durable responses in people with heavily pre-treated lymphomas New data reinforce the potential of combination regimens in earlier treatment settings and add to the robust body of evidence supporting ongoing Phase III studies SOUTH SAN FRANCISCO, Calif. / Dec 10, 2023 / Business Wire / Genentech, a member of the Roche Group (SIX:... Read More

Phase III HAVEN 7 primary data presented at ASH 2023 provide additional confidence in the favorable efficacy and safety profile of subcutaneous Hemlibra given soon after birth At nearly two years median follow-up in the descriptive, single-arm study, no babies experienced spontaneous bleeds requiring treatment, and all treated bleeds were as a result of trauma Safety results were consistent with previous studies of Hemlibra,... Read More

Phase III KATHERINE results reinforce Kadcyla as the standard of care for this population, with more than 82,000 people treated to date Long-term data also showed continued benefit in invasive disease-free survival for adjuvant Kadcyla compared to Herceptin in this study These data will be presented as an oral presentation at the 2023 San Antonio Breast Cancer Symposium and included in the official press program SOUTH SAN... Read More

Inavolisib in combination with palbociclib and fulvestrant more than doubled progression-free survival compared to palbociclib and fulvestrant alone The inavolisib combination has the potential to address resistance to treatment and poor prognosis associated with PIK3CA mutations These new data are being presented today in an oral presentation at the 2023 San Antonio Breast Cancer Symposium and shared with health authorities... Read More

Phase III (INAVO120) results shows that inavolisib in combination with palbociclib and fulvestrant significantly improved progression-free survival in the first-line setting PIK3CA mutations, found in approximately 40% of HR-positive breast cancers, are linked to tumor growth, disease progression, and treatment resistance Data will be shared with health authorities and presented at an upcoming medical meeting SOUTH SAN... Read More

Carmot Therapeutics’s R&D portfolio of clinical stage incretins has great potential to treat obesity, diabetes and potentially other diseases both as standalone medicines and in combination with Roche’s in-house assets Lead asset CT-388 is a Phase-2 ready dual GLP-1/GIP agonist with best-in-class potential for the treatment of obesity and its comorbidities Under the terms of the agreement, Roche will pay a purchase price of... Read More

Collaboration leverages expertise in artificial intelligence from Genentech and NVIDIA to unlock scientific innovation and empower R&D at a scale previously unattainable in pursuit of novel therapies Multi-year research effort aims to optimize and accelerate each company’s platforms and create innovations that could be applied in healthcare and beyond SOUTH SAN FRANCISCO, Calif. / Nov 21, 2023 / Business Wire / Genentech, a... Read More

The LightCycler PRO System is designed to be the most advanced qPCR technology for both clinical diagnostics and research. The new system will advance personalised healthcare and support outbreak readiness by delivering agility and flexibility for translational research and diagnostics. The innovative features of the system... Read More

RVO is the third indication for Vabysmo, in addition to wet, or neovascular, age-related macular degeneration and diabetic macular edema Approval is based on two Phase III studies demonstrating early and sustained vision improvements that were non-inferior to aflibercept Vabysmo also demonstrated rapid and robust drying of retinal fluid Additional U.S. label update across indications includes information on rare... Read More

Roche's navify Digital Pathology software platform now offers Ibex's Artificial Intelligence (AI) algorithms to support clinicians in the diagnosis of breast and prostate cancer. Roche and Ibex cloud-based digital pathology and AI solutions run on Amazon Web Services (AWS), enabling a scalable and sustainable ecosystem for pathology laboratories. This collaboration builds on Roche's Digital Pathology Open Environment on the... Read More

These Phase III data are the first and only to show an improvement in disease-free survival in early-stage resected ALK-positive non-small cell lung cancer (NSCLC) With about one in two people with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy, more effective treatment options are urgently needed to provide the best chance for cure Data are being presented as a... Read More

New data from Phase II FENopta study in relapsing multiple sclerosis (RMS) show fenebrutinib crosses the blood-brain barrier with the potential to act directly on the chronic inflammation related to multiple sclerosis (MS) More than 90% relative reduction in new/enlarging T2 lesions and new T1 gadolinium-enhancing (Gd+) lesions with fenebrutinib beginning at eight weeks The safety profile of fenebrutinib was consistent with... Read More

10-year efficacy data highlight Ocrevus’ impact on preventing disability progression and maintaining mobility in both relapsing and progressive forms of multiple sclerosis (MS) 10-year safety data from over 6,000 patients continue to reinforce consistent long-term safety profile of Ocrevus More than 3,200 women with MS treated with Ocrevus reported no increased risk in adverse pregnancy and infant outcomes with real-world... Read More

Late-breaking Phase III results show subcutaneous injection was non-inferior to intravenous infusion based on Ocrevus levels in the blood over 12 weeks Ocrevus subcutaneous injection was comparable to IV infusion in providing rapid and sustained depletion of B cells and near-complete suppression of MRI lesion activity in the brain over 24 weeks The safety profile of Ocrevus subcutaneous injection was consistent with the... Read More

Black and Hispanic / Latinx people with multiple sclerosis (MS) often experience more severe disease and greater disability Results from the Phase IV CHIMES trial demonstrate safety and efficacy consistent with data from the Ocrevus Phase III studies CHIMES sets new standard for inclusive research in MS, providing critical insights for improving clinical trial recruitment and retention among historically underrepresented... Read More

Vabysmo showed robust and sustained retinal drying up to 72 weeks and a safety profile consistent with previous trials If approved by the FDA, RVO would be Vabysmo’s third indication in addition to wet age-related macular degeneration (AMD) and diabetic macular edema (DME) Vabysmo is the first and only treatment that targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions SOUTH... Read More

RAINBOWFISH study met its primary endpoint with 80% of babies sitting without support for at least 5 seconds after 1 year of Evrysdi treatment — without treatment these babies would never be able to sit All babies were able to swallow and feed orally and none required permanent ventilation Evrysdi is the only non-invasive SMA therapy and is approved in over 100 countries with more than 11,000 patients treated globally SOUTH... Read More

Late-breaking results from Phase III trial of Ocrevus (ocrelizumab) subcutaneous injection and Phase II trial of BTK inhibitor fenebrutinib in multiple sclerosis (MS) will be presented 10-year Ocrevus efficacy and safety data show significant benefit in slowing long-term disability progression and consistent long-term safety profile in MS Additional Ocrevus real-world and clinical data show impact for underrepresented... Read More

Acceptance based on the Phase III COMMODORE 2 study, which demonstrated crovalimab achieved disease control and was well-tolerated in people with paroxysmal nocturnal hemoglobinuria (PNH) If approved, crovalimab will be the first monthly subcutaneous treatment for PNH, with the option to self-administer outside of a supervised healthcare setting Filing applications have also been accepted in the EU, China and Japan, and... Read More

The report shows digital health technologies demonstrate value, yet integrating them into care systems remains challenging. Involving healthcare professionals and patients in technology design and development is also critical for patient-centred care. 1 The report surveyed 10 countries, all of which have some foundations in place to use digital health technologies, such as regulatory frameworks and interoperability... Read More

ALINA data demonstrate Alecensa reduces disease recurrence in the early setting for people with ALK-positive non-small cell lung cancer (NSCLC), building on its long-established benefit in the advanced setting About half of people with NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy, therefore new treatments are urgently needed to provide the best chance for cure These data will be... Read More

SOUTH SAN FRANCISCO, Calif. / Aug 23, 2023 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has been made aware of an inadvertent disclosure of the second interim analysis of the Phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq® (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with... Read More

The cobas ® connection modules (CCM) sample conveyors system has been extended with newly developed elevator and overhead conveyor modules enabling more flexibility in lab design. CCM Vertical optimises the use of laboratory space without compromising on sample throughput of CCM up to 2,500 samples per hour. The fully modular system allows connection of different work areas in the laboratory without blocking walkways and... Read More

Ninety-four (94%) percent of global survey respondents working in healthcare agree that using data to drive healthcare creates new opportunities for patients and doctors to benefit from more personalised healthcare approaches. Yet 43% say disconnected or incompatible systems and data remain one of the greatest inhibitors to their organisation's ability to become more data-driven. Insufficient funding, organisational... Read More

Expanded alliance includes an agreement on eco social collaboration to jointly foster more sustainable diagnostic solutions, and the renewal of an agreement on hematology solutions for commercial and hospital laboratories, complementing the Roche Diagnostics portfolio 25-year partnership between Roche and Sysmex brings hematology testing innovations to laboratories and helps patients get access to routine hematology... Read More

Late-breaking post-hoc data indicate Vabysmo leads to less fibrosis, which may negatively impact vision, than aflibercept in people with diabetic macular edema (DME) Real-world data reinforce that first-line Vabysmo use improves outcomes and extends treatment intervals rapidly during the first four months for people with wet age-related macular degeneration (AMD) and DME Clinical data reiterate Vabysmo’s positive anatomical... Read More

Roche will unveil the next generation of core lab and molecular systems and cobas ® connection modules. Attendees can experience an integrated lab that goes beyond simply connecting individual technologies, demonstrating true end-to-end operational excellence. The Roche exhibit booth and Roche Idea Lab series featuring industry experts will highlight how our commitments to science, operational simplicity and partnership can... Read More

Phase III OCARINA II trial met primary and secondary endpoints Ocrevus 10-minute injection has the potential to further improve the treatment experience and expand Ocrevus® usage in MS centers with IV capacity limitations or without IV infrastructure Ocrevus remains the first and only therapy approved for both RMS and PPMS, and more than 300,000 people have been treated globally SOUTH SAN FRANCISCO, Calif. / Jul 13, 2023 /... Read More

Data from ongoing FIREFISH study confirm long-term efficacy and safety profile of Evrysdi in children with Type 1 SMA Ninety-one percent of children were alive at month 48 More than 95% maintained the ability to swallow - without treatment they would have required feeding support and majority would have died within 2 years Evrysdi is now approved in 99 countries with more than 8,500 patients treated globally SOUTH SAN... Read More

The Elecsys ® tTau/Abeta42 ratio helps clinicians define Alzheimer's disease (AD) biologically and expands Roche's AD CSF portfolio to include biomarkers for all three main pathological processes of Alzheimer's: amyloid plaques, tau tangles and neurodegeneration. Confirmation of amyloid pathology via CSF FDA-cleared... Read More

Pivotal study showed durable responses, with a 56% overall response rate, a 43% complete response (remission) rate, and a median duration of response of 1.5 years (18.4 months) Given over a fixed period of time, Columvi provides patients with a treatment end date and potential time off treatment Columvi is part of Genentech’s industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin’s lymphoma, which... Read More

The COMMODORE 2 study demonstrated that subcutaneous crovalimab every four weeks was non-inferior to intravenous eculizumab every two weeks, with comparable safety, in people new to C5 inhibitors Monthly self-administration of subcutaneous crovalimab has the potential to address the high burden of a disease that requires lifelong treatment including in settings where access to current C5 inhibitors is limited The COMMODORE 1... Read More

Roche's Cerebrospinal Fluid (CSF) assays address unmet needs in the detection of amyloid pathology by offering greater accessibility and support for Alzheimer's disease (AD) diagnosis. Currently, AD diagnosis is largely based on various cognitive tests, routine laboratory tests and structural imaging (MRI or CT scan), providing accurate diagnosis in only 70-80% of cases. 1 Available across Canada , Roche's assays can measure... Read More

Roche will unveil the next generation of its serum work area, several molecular systems and the cobas ® connection module. The company will introduce navify ® digital solutions that help laboratories address their needs for digital infrastructure, operational excellence and medical insights. Attendees can experience an integrated lab that goes beyond simply connecting individual technologies to demonstrate true end-to-end... Read More

Fenebrutinib is an investigational, potent and highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor, the only reversible BTK inhibitor currently in Phase III multiple sclerosis (MS) trials Phase II study met its primary and secondary endpoints by reducing the total number of new gadolinium-enhancing T1 brain lesions and significantly reducing the total number of new or enlarging T2 brain lesions compared to placebo... Read More

Acceptance based on two Phase III studies that demonstrated early and sustained vision improvement with Vabysmo, meeting primary endpoint of non-inferiority compared to aflibercept Application was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluid If approved, RVO would be the third indication for Vabysmo in addition to wet age-related macular degeneration (AMD) and diabetic macular... Read More

Post-hoc analyses from four Phase III studies indicate Vabysmo dried retinal fluid faster with fewer injections in wet age-related macular degeneration (AMD) and diabetic macular edema (DME) More Vabysmo patients with wet AMD had absence of retinal fluid at 12 weeks in a post-hoc analysis from the Phase III TENAYA and LUCERNE studies DME patients treated with Vabysmo had less blood vessel leakage in the macula at 16 weeks in... Read More

Roche, Genentech and partners embark on global prevalence research, trend-spotting with digital analysis, and telehealth initiatives to assess & address deterrents to brain health to better understand holistic health journeys of patients with neurologic diseases Long-term data to be presented demonstrate delayed MS disability with Ocrevus; reduced disease activity with Enspryng in NMOSD and with Evrysdi in SMA Data from... Read More

Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma, an aggressive disease and the most common form of non-Hodgkin’s lymphoma in the U.S. POLARIX trial showed the Polivy combination reduced the risk of disease progression, relapse or death by 27% compared to the standard of care, R-CHOP, with a comparable safety profile First-line treatment... Read More

In the first-ever positive Phase III trial in the adjuvant hepatocellular carcinoma (HCC) setting, Tecentriq plus Avastin reduced the risk of disease recurrence by 28% Up to 80% of people with this type of HCC experience disease recurrence, at which point they are faced with poorer prognosis and shorter survival These data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2023 and... Read More

Vabysmo data suggest rapid and robust drying of retinal fluid in patients with wet age-related macular degeneration and diabetic macular edema Real-world studies of Vabysmo demonstrate ability to extend treatment intervals in the first four months while maintaining visual acuity Clinical data on an investigational anti-interleukin-6 treatment in uveitic macular edema (UME) will be presented for the first time SOUTH SAN... Read More

At the global HIMSS 1 Conference, Roche showcases navify Algorithm Suite, a single platform offering clinicians access to medical algorithms generating insights to help improve care decisions. navify Algorithm Suite is a secure digital ecosystem that links physicians easily to a range of medical algorithms from Roche and its... Read More

SOUTH SAN FRANCISCO, Calif. / Mar 20, 2023 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new long-term data for Evrysdi ® (risdiplam) in a broad range of people aged 2-25 years with spinal muscular atrophy (SMA) from the pivotal SUNFISH study. Data confirm increases in motor function were sustained at four years and the overall rate of adverse events continued to... Read More

SOUTH SAN FRANCISCO, Calif. / Mar 09, 2023 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 in favor of Polivy ® (polatuzumab vedotin-piiq) in combination with Rituxan ® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people... Read More

The VENTANA PD-L1 (SP263) Assay helps determine which patients with non-small cell lung cancer (NSCLC) may be eligible for treatment with Libtayo monotherapy 1 based on the results of the Phase III EMPOWER-Lung 1 study. This additional approval will allow more patients with locally advanced and metastatic NSCLC broader access... Read More

It is critical to strengthen laboratories to enable more people to access quality testing and build stronger, resilient healthcare systems Public-private partnerships contribute to strengthening laboratory systems by leveraging the respective strengths, experience, and resources of the partners About 2 billion people worldwide are estimated to be infected with tuberculosis and more than 38 million people globally are living... Read More

SOUTH SAN FRANCISCO, Calif. / Feb 10, 2023 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive new data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo® (faricimab-svoa) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO) at 24 weeks. The studies showed that treatment with Vabysmo resulted in early and... Read More

New agreement expands activities to include a wide-range of companion diagnostics, including tissue and blood-based biomarkers, sequencing and digital pathology. Collaboration builds on commitment to personalised healthcare through expanding access of companion diagnostics to enable targeted treatment options for patients. TUCSON, Ariz. , Feb. 9, 2023 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it... Read More

SOUTH SAN FRANCISCO, Calif. / Feb 07, 2023 / Business Wire / Genentech , a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the global Phase III COMMODORE 2 study, evaluating the efficacy and safety of crovalimab in people with paroxysmal nocturnal hemoglobinuria (PNH) who have not been previously treated with complement inhibitors. The study met its co-primary efficacy endpoints... Read More

Jana Care and Roche Diagnostics aim to develop point-of-care blood testing portfolio to address unmet needs for patients at-home and in remote settings. Jana Care's at-home testing platform to be distributed to global markets through Roche. WATERTOWN, Mass. , Jan. 30, 2023 /PRNewswire/ -- Jana Care , Inc. an early stage at-home In Vitro Diagnostics (IVD) company, and Roche Diagnostics (SIX: RO, ROG) (OTCQX: RHHBY), a global... Read More

Pivotal Phase III IMbrave050 study investigating Tecentriq plus Avastin in people with early-stage hepatocellular carcinoma (HCC) at high risk of recurrence following surgery met primary endpoint of recurrence-free survival New adjuvant treatments are urgently needed as an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery Data will be discussed with health authorities globally,... Read More

If approved, glofitamab would be the first fixed-duration CD20xCD3 T-cell engaging bispecific antibody approved to treat the most aggressive type of non-Hodgkin’s lymphoma Results from the pivotal Phase I/II NP30179 study showed glofitamab induced durable response rates in people with heavily pretreated large B-cell lymphoma, with 40% achieving a complete response Glofitamab is part of Genentech’s industry-leading portfolio... Read More

With Lunsumio, people with heavily pretreated follicular lymphoma (FL) may experience remission with a chemotherapy-free, fixed-duration treatment that can be accessed in an outpatient setting Results from the pivotal Phase II GO29781 study demonstrated that 80% of patients who received at least two prior therapies achieved durable response rates, with 60% experiencing complete remission Discovered and developed by Genentech... Read More

Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 Since the beginning of the pandemic, more than one million people hospitalized with COVID-19 have been treated with Actemra worldwide Actemra is approved for this use in more than 30 countries for the treatment of COVID-19 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA)... Read More

The potential for a tripledemic exists, as influenza, COVID-19 and RSV cases rise. Two out of three Americans are confused by the differences between PCR and rapid antigen tests in detecting viruses and when to use them. It's important to know which test to use, as PCR testing is the best option for early detection, when... Read More

Data showcase the potential of glofitamab and Lunsumio to address diverse patient needs Data presented at ASH 2022 and simultaneously published in the New England Journal of Medicine showed that glofitamab , given as a fixed course, induced early and durable responses in people with heavily pre-treated large B-cell lymphoma 1,2 27-month follow-up data showed Lunsumio continued to induce high and durable responses in people... Read More

Updated data from the phase III POLARIX study continue to demonstrate a statistically significant reduction in the risk of disease worsening or death for people with previously untreated diffus e large B-cell lymphoma (DLBCL) 1 Patients receiving Polivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes, during and after fixed-duration treatment, to those receiving the current standard-of-care,... Read More

The HAVEN 7 study was designed to further confirm the benefit of preventative treatment (prophylaxis) with Hemlibra from birth in previously untreated or minimally treated infants with severe haemophilia A without inhibitors In the study, 77.8% of participants had no bleeding episodes that required treatment 1 In addition, real-world efficacy and safety data from the EUHASS database and ATHN 7 study were also presented 2,3... Read More