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.

Swiss drugmaker Roche Holding AG plans to sell or close its drug manufacturing plant in Vacaville, California, or it will shut the factory down by 2029, according to e-mailed letters to the plant's workers obtained by Reuters on Wednesday.

Roche looking to sell Vacaville, California plant

Arcus Biosciences

Shares of Arcus Biosciences surged Friday after Roche provided "meaningful" evidence for a new cancer treatment class. The post Arcus Biosciences Soars On Roche's 'Meaningful' Results In A New Cancer Drug Class appeared first on Investor's Business Daily.

Arcus Biosciences Soars On Roche's 'Meaningful' Results In A New Cancer Drug Class

Basel, 26 May 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will be presenting new data on six approved and investigational medicines across ten cancer types at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held 2 – 6 June.

Roche to present new data in blood cancers and solid tumours from its broad portfolio at ASCO 2023

It is expected that the market opportunity for disease-modifying therapies for MS will reach $29.8 billion in 2030; further projected that OCREVUS could generate sales of $6.3 billion by 2030. Roche Holding AG reported positive results reported from its phase 2 FENopta study, which used BTK inhibitor fenebrutinib for patients with RMS; Fenebrutinib is the only reversible BTK inhibitor in phase 3 testing for MS positive results reported from phase 2 FENopta study, which used BTK inhibitor fenebrutinib for patients with RMS; Fenebrutinib is the only reversible BTK inhibitor in phase 3 testing for MS.

Roche, With Ocrevus And Fenebrutinib Advancement, Should Be Top MS Contender

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The debt ceiling crisis is coming down to the wire. We're possibly already out of time to prevent default and just don't know it. UBS estimates a short default could create a 20% bear market and a one-month default could lead to a 44% crash.

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Roche's (RHHBY) investigational oral fenebrutinib meets its primary and secondary endpoints in the phase II FENopta study.

Roche's (RHHBY) MS Drug Meets Goals in the Phase II Study

Roche said on Wednesday that its multiple sclerosis drug candidate, part of a class of compounds that has been linked to cases of liver damage, reduced brain lesions in a mid-stage trial and that no new safety concerns emerged.

Roche says new MS drug shown to reduce brain lesions

Basel, 17 May 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase II FENopta study evaluating investigational oral fenebrutinib in adults with relapsing forms of multiple sclerosis (RMS). The study met its primary and secondary endpoints, showing oral fenebrutinib significantly reduced magnetic resonance imaging (MRI) markers of MS disease activity in the brain compared to placebo. Additionally, pre-clinical data have shown fenebrutinib to be potent and highly selective, and it is the only reversible inhibitor currently in Phase III trials for MS.

Roche's BTK inhibitor fenebrutinib significantly reduced brain lesions in people with relapsing forms of multiple sclerosis

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase II FENopta study evaluating investigational oral fenebrutinib in adults with relapsing forms of multiple sclerosis (RMS). The study met its primary and secondary endpoints, showing oral fenebrutinib significantly reduced magnetic resonance imaging (MRI) markers of MS disease activity in the brain compared to placebo. Additionally, pre.

Genentech's BTK Inhibitor Fenebrutinib Significantly Reduced Brain Lesions in People With Relapsing Forms of Multiple Sclerosis

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.

Roche showcases commitment to advancing innovative diagnostic solutions at WorldLab-EuroMedLab

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HONG KONG & SUZHOU, China & SHANGHAI--(BUSINESS WIRE)--Zion Pharma Limited, a Chinese biotechnology company focused on the development of brain-penetrable compounds, today announced that Roche has acquired the global rights to Zion's lead program, ZN-A-1041. ZN-A-1041 is an orally administered selective tyrosine kinase inhibitor targeting the Human Epidermal Growth Factor Receptor 2 (HER2). ZN-A-1041 was designed to be blood-brain-barrier-penetrant, and has the potential to treat or prevent the.

Zion Pharma Announces Global Agreement with Roche to Develop and Commercialize a Blood Brain Barrier Penetrant Oral HER2 Tyrosine Kinase Inhibitor

Basel, 9 May 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). The sBLA is based on results from the phase III BALATON and COMINO studies that demonstrated treatment with Vabysmo provided early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept.1,2 Vabysmo's safety profile was consistent with previous trials.

FDA accepts application for Roche's Vabysmo for the treatment of retinal vein occlusion (RVO)

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 accepted the company's supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). The sBLA is based on results from the Phase III BALATON and COMINO studies that demonstrated treatment with Vabysmo provided early and su.

FDA Accepts Application for Genentech's Vabysmo for the Treatment of Retinal Vein Occlusion (RVO)

Basel, 4 May 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the Institute of Human Biology (IHB) focussing on advancing research in the field of human model systems such as organoids. Leveraging human model systems, the institute aims to accelerate drug discovery and development by improving the understanding of how organs function and how diseases develop. Ultimately, this will help to bring medicines to patients faster. These efforts will also enable early testing of which drug candidates are safe and which molecules would work best for each patient.

Roche launches Institute of Human Biology to accelerate breakthroughs in R&D by unlocking the potential of human model systems

Roche Holding AG (RHHBY) Q1 2023 Earnings Call Transcript.

Roche Holding AG (RHHBY) Q1 2023 Earnings Call Transcript

Basel, 26 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Columvi® (glofitamab), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Columvi has the potential to change the current standard of care in DLBCL. As well as inducing early and long-lasting responses in people with heavily pre-treated or refractory DLBCL, potentially allowing patients a treatment free period, Columvi is designed to be given for a fixed period of time so that people know when their treatment will end. It is also an off-the-shelf therapy, meaning that people do not have to wait for cell collection and genetic engineering before starting treatment, which could be particularly important for patients who are at a high-risk of their disease progressing. A final decision is expected from the European Commission (EC) in the near future.

CHMP recommends EU approval of Roche's fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma

Roche's (RHHBY) performance in first-quarter 2023 is pretty ho-hum as COVID-19-test sales continue to decline.

Roche (RHHBY) Q1 Revenues Decline on Lower COVID-19 Test Sales

GlaxoSmithKline

GSK and Roche both outplayed declining Covid-related sales in the first quarter to beat Wall Street's earnings expectations. The post Pharma Behemoths GSK, Roche Outplay Covid Declines To Beat Quarterly Calls appeared first on Investor's Business Daily.

Pharma Behemoths GSK, Roche Outplay Covid Declines To Beat Quarterly Calls

Roche Holding AG on Wednesday posted a decline in sales for the first quarter as its diagnostics division suffered from significantly lower demand for Covid-19 tests, and backed its outlook for the year.

Roche sees sales drop on lower demand for COVID-19 tests, but backs view

Basel, 26 April 2023 As expected, significantly lower demand for COVID-19 tests leads to a decrease in G roup sale s (-3%1 at constant exchange rates [CER] and -7% in Swiss francs); excluding this effect, Group sales grow 8% Pharmaceuticals Division sales up 9%; strong demand for newer medicines; Vabysmo for severe eye diseases is already the strongest growth driver Diagnostics Division base business grows 4%, while divisional sales are 28% lower due to exceptionally high demand for COVID-19 tests in the first quarter of 2022 Highlights in the first quarter: US approval of Polivy (first-line treatment for an aggressive form of blood cancer) EU approval of Hemlibra (moderate haemophilia A) Positive phase III data for Vabysmo (retinal vein occlusion, a serious eye disease), Tecentriq plus Avastin (adjuvant therapy for certain forms of liver cancer) and crovalimab (paroxysmal nocturnal haemoglobinuria, a rare blood disease) Positive four-year efficacy and safety data for Evrysdi (spinal muscular atrophy) Launch of new assays to identify clinically relevant mutations in brain cancers Outlook for 2023 confirmed Roche CEO Thomas Schinecker: “We saw strong growth in the first quarter in both divisions' base business, which largely compensated for the expected drop in sales of COVID-19 tests. We made progress in our pipeline in the first quarter, especially in blood cancer.

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong sales growth in base business of both divisions in the first quarter; Group sales decline due to expected drop in demand for COVID-19 tests

Basel, 25 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that post-hoc data indicate treatment with Vabysmo® (faricimab) led to greater and faster drying of retinal fluid with fewer injections compared to aflibercept in neovascular or ‘wet' age-related macular degeneration (nAMD).1 In diabetic macular edema (DME), post-hoc data suggest Vabysmo treatment resulted in faster drying with fewer injections as well as less blood vessel leakage in the macula, the centre of the retina, compared to aflibercept.2,3 The analyses from the phase III TENAYA and LUCERNE (nAMD) and YOSEMITE and RHINE (DME) studies were shared at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, held from 23-27 April in New Orleans, United States.

New Vabysmo data suggest greater retinal drying versus aflibercept in nAMD and DME

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that post-hoc data indicate treatment with Vabysmo® (faricimab-svoa) led to greater and faster drying of retinal fluid with fewer injections compared to aflibercept in wet, or neovascular, age-related macular degeneration (AMD). In diabetic macular edema (DME), post-hoc data suggest Vabysmo treatment resulted in faster drying with fewer injections as well as less bl.

New Vabysmo Data Suggest Greater Retinal Drying Versus Aflibercept in Wet Age-Related Macular Degeneration and Diabetic Macular Edema

SAN FRANCISCO--(BUSINESS WIRE)-- #AANAM--PicnicHealth announces an expansion of its real-world data strategic partnership with Roche and Genentech to advance neurological disease research.

PicnicHealth Announces Continued Real-World Data Strategic Partnership with Roche and Genentech to Advance Neurological Disease Research

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is announcing three new partnerships focused on improving brain health outcomes. These industry-leading initiatives are designed to quantify and assess the complexity, economic impact and patient and care partner burden of brain health conditions, and generate robust data around the nuanced dynamics of neurologic care. Conditions affecting the brain and nervous system cause more de.

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