Roche Holding AG

Roche Holding AG is a research healthcare company. It operates through the Roche Pharmaceuticals and Diagnostics segments. The Roche Pharmaceutical division comprises the business segments, such as Roche Pharmaceuticals and Chuga. The Diagnostic division consists of the following four business areas: centralized and point of care solutions, molecular diagnostics, tissue diagnostics and diabetes care. The company was founded by Fritz Hoffmann-La Roche on October 1, 1896 and is headquartered in Basel, Switzerland.

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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

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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.

Genentech Announces Industry-Leading Brain Health Research Collaborations and Latest Data Across Neuroscience Medicines at AAN 2023 Annual Meeting

Roche (RHHBY) gets full approval for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan, cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients who have previously untreated DLBCL.

Roche (RHHBY) Polivy Combination for DLBCL Gets Full Approval

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Two Barron's Annual-Roundtable, plus-two Bloomberg-Intelligence articles and one from InvestorPlace published late-January and April listed 119 stocks for 2023; 97 of-those were unduplicated US publicly-listed companies, of which 69 paid dividends.

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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S.

FDA Approves Genentech's Polivy in Combination With R-CHP for People With Certain Types of Previously Untreated Diffuse Large B-cell Lymphoma

Basel, 19 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of two or greater. This FDA decision converts the accelerated approval of Polivy in combination with bendamustine and Rituxan for relapsed or refractory (R/R) DLBCL after at least two prior therapies to regular approval.

[Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche's Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma

Roche's (RHHBY) new data from the late-stage IMbrave050 study reveals that the combination of Tecentriq and Avastin reduces the risk of cancer relapsing in people with certain types of adjuvant liver cancer in a phase III study.

Roche (RHHBY) Announces Data on Tecentriq Combo for HCC

Roche Holding AG said Sunday that its tecentriq immunotherapy drug showed further positive results in an advanced study, demonstrating significant improvement in recurrence-free survival in patients.

Roche's Tecentriq shows further good survival rates as cancer treatment

Basel, 16 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new data from the Phase III IMbrave050 study that show Tecentriq® (atezolizumab) plus Avastin® (bevacizumab) demonstrated a statistically significant improvement in recurrence-free survival (RFS) in people with hepatocellular carcinoma (HCC) at high risk of disease recurrence following liver resection or ablation with curative intent.2

Roche's Tecentriq plus Avastin reduced the risk of cancer returning in people with certain types of adjuvant liver cancer in a Phase III study

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new data from the Phase III IMbrave050 study that show Tecentriq® (atezolizumab) plus Avastin® (bevacizumab) demonstrated a statistically significant improvement in recurrence-free survival (RFS) in people with hepatocellular carcinoma (HCC) at high risk of disease recurrence following liver resection or ablation with curative intent.

Genentech's Tecentriq Plus Avastin Reduced the Risk of Cancer Returning in People With Certain Types of Adjuvant Liver Cancer in a Phase III Study

Basel, 13 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data for its approved and investigational medicines will be highlighted in 30 abstracts at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, which will be held from 23-27 April 2023 in New Orleans, United States. The abstracts showcase the strength and breadth of Roche's Ophthalmology portfolio, including post-hoc data from phase III Vabysmo® (faricimab) studies that support its benefit in drying retinal fluid in neovascular or ‘wet' age-related macular degeneration (nAMD) and diabetic macular edema (DME).1 - 3 Real-world data on Vabysmo treatment patterns and outcomes will be presented, as well as approaches to personalised healthcare that include the use of artificial intelligence (AI) modelling to predict retinal disease progression.4-7 Additionally, phase I data for an investigational anti-interleukin-6 (IL-6) treatment in uveitic macular edema (UME), to be presented for the first time, suggest the monoclonal antibody may improve visual acuity in patients with UME.8

Roche data highlights strength of ophthalmology portfolio and commitment to advancing eye care at ARVO 2023

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new data for its approved and investigational medicines will be highlighted in 30 abstracts at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, which will be held from April 23-27 in New Orleans, LA.

News for Roche Holding AG Stock (RHHBY)