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.

Basel, 11 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of Anti-PRAME (EPR 20330) Rabbit Monoclonal Primary Antibody to identify PRAME protein expression in tissue samples from patients with suspected melanoma. Because the PRAME (PReferentially expressed Antigen in MElanoma) protein is expressed in most melanomas, the PRAME (EPR20330) Antibody* is used as an aid to differentiate between benign and malignant lesions to help improve diagnostic decisions. If PRAME expression is detected, this suggests that the lesion is malignant. “Every four minutes, one person dies from skin cancer. However, when detected early, localised melanoma is highly curable with a simple surgical excision,” said Thomas Schinecker, CEO of Roche Diagnostics. “Identifying this critical biomarker helps clinicians determine if their patient has melanoma. We're proud to add the PRAME assay to our already comprehensive test menu of dermatology biomarkers that help inform a patient's diagnosis and treatment.” Melanoma is an aggressive skin cancer that originates from melanocytes, which are cells in the skin and eyes that produce and contain melanin. Melanoma develops when unrepaired DNA damage to melanocytes triggers mutations that cause the melanocytes to grow rapidly and form malignant tumours. When detected early, the 5-year survival rate is 99 percent.1 The first test that is used to evaluate a potential melanocytic lesion is a hematoxylin and eosin (H&E) stain of the patient's tissue sample. However, not all melanomas are easily diagnosed using H&E alone. Studies suggest that detection of PRAME expression by immunohistochemistry (IHC) complements findings from routinely used tests and enables more informed clinical decisions and improved patient outcomes.2-4 In particularly challenging cases, use of PRAME IHC may highlight abnormal cells expressing the PRAME protein and provide more confidence in diagnosis of melanoma. More information about PRAME will be presented at the International Academy of Pathology 2022 World Congress in Sydney, Australia on 14 October 2022 in a session titled “The diagnostic approach to melanocytic lesions”. About the Anti-PRAME (EPR 20330) Rab bit Monoclonal Primary Antibody The PRAME (EPR20330) Antibody is fully automated on the full line of Roche BenchMark IHC/ISH instruments. This antibody is validated for use using OptiView DAB IHC Detection, ultraView Universal DAB Detection & ultraView Universal Alkaline Phosphatase Red Detection Kits giving added flexibility to laboratories and pathologists' preferences.

Roche launches PRAME (EPR20330) Antibody to identify PRAME protein expression in patients that may have melanoma

Basel, 05 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its industry-leading neuromuscular portfolio will be presented at the World Muscle Society (WMS) congress, 11th-15th October 2022. These data demonstrate Roche's commitment to advancing clinical understanding and supporting the development of treatments for people living with neuromuscular disorders.

Roche to present new data from its expanding neuromuscular disease portfolio at World Muscle Society 2022

Basel, 4 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) approved the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody* to identify metastatic breast cancer patients with low HER2 expression for whom ENHERTU ® (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment. ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Roche receives FDA approval for first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for ENHERTU

Basel, 3 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Matt Sause (45), currently Head of Roche Diagnostics' North America Region, will become CEO Roche Diagnostics and a member of the Corporate Executive Committee effective 1 January 2023.

[Ad hoc announcement pursuant to Art. 53 LR] Roche: Change in the Corporate Executive Committee in January 2023

This can be attributed to Biogen's success with its Alzheimer's treatment - Lecanemab - in late-stage clinical trials.

What's Happening With Roche (RHHBY) Stock?

Novartis

NVS vs. RHHBY: Which Stock Is the Better Value Option?

NVS vs. RHHBY: Which Stock Should Value Investors Buy Now?

We comment on the latest company's development after its Pharma Day. Is Roche's dividend at risk? We don't believe so.

Roche: New Drugs Will Outpace Biosimilar Competition

Eli Lilly

The results of a key Alzheimer's drug trial on Wednesday have reignited decades-old hopes that targeting a particular protein helps arrest the progression of the fatal brain disease, giving a big boost to similar studies being run by Roche and Eli Lilly.

Analysis: Alzheimer's drug breakthrough big boost for Roche, Eli Lilly

Basel, 26 September 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Julie Brown has notified the Board that she will step down as a member of the Roche Board of Directors as she has accepted a management role at another pharmaceutical company. This change will be effective from today.

Change in the Roche Board of Directors

Roche's new compact and modular system is designed to simplify daily operations, increase lab productivity, and support the delivery of better patient care through automation of manual tasks. cobas® pure integrated solutions brings together three diagnostic technologies on a single platform to optimize space and resources in low- to mid-volume laboratories.

Roche granted FDA clearance for cobas pure integrated solutions for low- to mid-volume laboratories

The European Commission approves Roche's (RHHBY) Vabysmo for treating neovascular or wet age-related macular degeneration and visual impairment due to diabetic macular edema.

Roche's (RHHBY) Vabysmo Gets Approval for nAMD & DME in Europe

Roche Holding AG said Monday that its vision-loss treatment Vabysmo has been approved in the European Union after successful phase-3 study data.

Roche's vision-loss drug Vabysmo gets EU nod

Basel, 19 September 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) approved Vabysmo® (faricimab) for the treatment of neovascular or ‘wet' age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). These retinal conditions are two of the leading causes of vision loss worldwide, affecting more than 40 million people 1,2,3,4

European Commission approves Roche's Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss

Roche bottomed on June 16, reached my previously set target, and is forming a sound base from which it could attempt to break out. The stock is a leader in its industry despite underperforming the broader healthcare sector, which has been performing well in the past 3 months.

Roche Is Trying To Break Out (Technical Analysis)

AstraZeneca

Shares in pharmaceutical giants including Roche, Novo Nordisk, Eli Lilly and AstraZeneca were little changed Wednesday despite getting a ratings boost from analysts at Berenberg, who cited respective returns on research and development investment and the ability of those companies to withstand pressure coming from recent U.S drug price reform.

AstraZeneca, Eli Lilly and Roche among pharmaceutical companies upgraded for high returns on R&D investments, analysts say

The VENTANA PD-L1 (SP263) Assay helps determine which patients with non-small cell lung cancer may be eligible for treatment with Libtayo monotherapy1 based on the results of the Phase III EMPOWER-Lung 1 study. This additional approval will allow more patients with locally advanced and metastatic non-small cell lung cancer broader access to the immunotherapy Libtayo.

Roche's VENTANA PD-L1 (SP263) Assay receives CE IVD approval to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo

SEATTLE--(BUSINESS WIRE)--Good Therapeutics, a privately held company, today announced it has entered into a definitive merger agreement to be acquired by Roche (SIX: RO, ROG; OTCQX: RHHBY). With this acquisition, Roche will gain rights to Good Therapeutics' innovative, conditionally active, PD-1-regulated IL-2 program and an exclusive right to the platform technology for the development of PD-1-regulated IL-2 receptor agonist therapeutics. Under the terms of the merger agreement, Roche will ma

Good Therapeutics Announces Acquisition of Conditionally Active PD-1-regulated IL-2 Program by Roche

The VENTANA PD-L1 (SP263) Assay helps determine which patients with non-small cell lung cancer may benefit from treatment with Tecentriq immunotherapy based on the results of the Phase III IMpower010 study. 1 This label expansion strengthens Roche's industry-leading portfolio of companion diagnostics and builds on its commitment to improve personalised healthcare for better patient outcomes.

Roche's VENTANA PD-L1 (SP263) test gains CE label expansion as a companion diagnostic to identify non-small cell lung cancer patients eligible for Tecentriq

Basel, 23 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the Digital LightCyclerⓇ System, Roche's first digital polymerase chain reaction ( PCR) system. This next-generation system detects disease and is designed to accurately quantify trace amounts of specific DNA and RNA targets not typically detectable by conventional PCR methods.

Roche launches a digital PCR system, a powerful new diagnostics platform in the fight against cancer and other diseases

Roche has developed a COVID-19 test for researchers that detects the latest subvariant BA.2.75 and can differentiate it from BA.4 or BA.5 This new test is a highly accurate tool that specifically targets mutations found in the BA.2.75 subvariant - providing important epidemiological insights in monitoring the potential impact of therapeutics, vaccines, and public health interventions PLEASANTON, Calif. , Aug. 22, 2022 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) and its subsidiary TIB Molbiol have developed a  COVID-19 test for researchers that detects and differentiates the latest subvariant of interest BA.2.75.

Roche launches COVID-19 test that detects and differentiates the emerging variant of interest BA.2.75

Roche's (RHHBY) sBLA seeking approval for the use of Polivy in combination with R-CHP for previously untreated diffuse large B-cell lymphoma in adults has been accepted in the United States.

Roche's (RHHBY) sBLA For Polivy Combo Accepted by FDA

Basel, 16 August 2022 - Roche (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 Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). The FDA is expected to make a decision on approval by 2 April 2023. “The POLARIX study results suggest that Polivy plus R-CHP could transform the treatment of this aggressive malignancy, and we are working with the FDA to bring this combination to newly diagnosed DLBCL patients as soon as possible,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We hope it will become the new standard of care for the first-line treatment of DLBCL, potentially reducing the need for subsequent treatments and limiting patient burden.” DLBCL is an aggressive blood cancer. Although DLBCL often responds to initial treatment, it is not cured with the current standard of care in four out of 10 people. Most relapses occur within two years of starting treatment and the majority of those who require subsequent lines of therapy have poor outcomes. The sBLA is based on results from the pivotal phase III POLARIX trial, which is the first in two decades to show a clinically meaningful improvement in progression-free survival (PFS) compared to the current standard of care Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP). The risk of disease progression, relapse or death was reduced by 27% with Polivy plus R-CHP compared with R-CHOP after a median follow-up of 28.2 months (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57–0.95; p

FDA accepts supplemental Biologics License Application for Roche's Polivy combination for people with previously untreated diffuse large B-cell lymphoma

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 Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). The FDA is

FDA Accepts Supplemental Biologics License Application for Genentech's Polivy Combination for People With Previously Untreated Diffuse Large B-Cell Lymphoma

Basel, 15 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the Elecsys® IGRA SARS-CoV-2 test in countries that accept the CE Mark1. The Elecsys IGRA SARS-CoV-2 test supports the better understanding of immune response to SARS-CoV-2 infection and vaccination. The test will be an additional tool to make better-informed decisions around care, sanitary measures and treatment options. This will be particularly important for at-risk patient groups.

Roche launches new diagnostic test for the better understanding of immune response to SARS-CoV-2

Roche (RHHBY) obtains FDA approval for expanded indication of influenza drug Xofluza.

News for Roche Holding AG Stock (RHHBY)