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, 13 November 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European Commission in the near future.

CHMP recommends EU approval of Roche's Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data for its approved and investigational medicines will be presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition from December 5–8, 2020. Eleven Genentech medicines will be featured in more than 80 abstracts, including 22 oral presentations. With studies spanning 16 blood disorders, including non-Hodgkin's lym

Genentech to Present New Data Across 16 Blood Disorders at the American Society of Hematology 2020 Annual Meeting

Basel, 2 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. “Tecentriq in combination with Avastin is the first treatment to be approved in over a decade that has improved overall survival for people with previously untreated advanced or unresectable hepatocellular carcinoma,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We're delighted that people in Europe can now benefit from this combination and we look forward to working with individual countries within the EU to ensure people can access the combination as soon as possible.” “The results of the IMbrave150 study mark a breakthrough in the treatment of advanced liver cancer, one of the few cancers with a rising death rate and limited options in the first-line setting,” said Dr Arndt Vogel, Professor of Medicine at Hannover Medical School. “After many failures in the last 12 years, the combination of Tecentriq and Avastin shows improvement in overall survival compared to sorafenib and offers patients the opportunity for improved disease control with a high overall response rate.” The approval is based on results from the Phase III IMbrave150 study, which showed that Tecentriq in combination with Avastin reduced the risk of death (overall survival [OS]) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42–0.79; p=0.0006) and reduced the risk of disease worsening or death (progression-free survival [PFS]) by 41% (HR=0.59; 95% CI: 0.47–0.76; p

European Commission approves Roche's Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer

PLEASANTON, Calif., Oct. 29, 2020 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of expanded claims for the cobas® EGFR Mutation Test v2 as a companion diagnostic (CDx) for a broad group of therapies in the treatment of...

Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer

              Basel, 29 October 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. “Today's approval of Tecentriq in combination with Avastin for unresectable hepatocellular carcinoma means that people in China now have a cancer immunotherapy option which is changing the treatment landscape for this aggressive disease”, said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “With almost half of the world's hepatocellular carcinoma cases diagnosed in China, this approval marks a major advance for Chinese patients.” “In China, primary liver cancer ranks as the fourth most common malignancy and is the second leading cause of cancer death. With most patients diagnosed at the intermediate and advanced stages where surgery or other locoregional therapies are not an option, there is an urgent need for effective treatments for unresectable HCC”, said Prof. Shukui Qin, Leading Principal Investigator of the IMbrave150 study in China and Chairman of the Liver Cancer Expert Committee of the Chinese Society of Clinical Oncology (CSCO). “The IMbrave150 study demonstrated that the combination of Tecentriq and Avastin in this setting can significantly improve outcomes for patients. It is truly gratifying news that the combination is now approved in China and gives a new option to Chinese liver cancer patients.” Liver cancer is one of the most common cancers in China, accounting for nearly 400,000 diagnoses and approximately 368,000 deaths every year, equivalent to over 1,000 per day.1 Only 20% of people with HCC in China are diagnosed in the early stages, when curative treatments are still an option.2 The average 5-year survival rate for people in China with liver cancer is only approximately 15%.3 Roche is committed to tackling liver disease right across the disease journey, from the earliest stages through to advanced disease, with the ultimate goal of one day stopping chronic liver disease. The approval was based on results of the Phase III IMbrave150 study, which included analyses of a cohort of Chinese patients (n=194) from the same study. Data from this cohort were consistent with the global results. Among Chinese patients, Tecentriq in combination with Avastin reduced the risk of death (overall survival; OS) by 56% (hazard ratio [HR]=0.44; 95% CI: 0.25–0.76) and reduced the risk of disease worsening or death (progression-free survival; PFS) by 40% (HR=0.60; 95% CI: 0.40–0.90), compared with sorafenib. Tecentriq and Avastin were generally well-tolerated with manageable toxicities, and the safety profile was consistent with the known safety profiles of the individual medicines and with the underlying disease. Global results from the IMbrave150 study demonstrated that Tecentriq in combination with Avastin reduced the risk of death (OS) by 42% (HR=0.58; 95% CI: 0.42–0.79; p=0.0006) and reduced the risk of disease worsening or death (PFS) by 41% (HR=0.59; 95% CI: 0.47–0.76; p

Roche's Tecentriq in combination with Avastin approved in China for people with the most common form of liver cancer

Hanover Insurance Group

The Hanover Insurance Group, Inc.'s (THG) CEO Jack Roche on Q3 2020 Results - Earnings Call Transcript

Roche (RHHBY) signs a contract with privately-held Atea Pharmaceuticals for jointly developing AT-527, an oral treatment for COVID-19 patients.

Roche (RHHBY) Inks Deal to Develop Oral Coronavirus Treatment

The Swiss pharma giant will have exclusive rights to the antiviral outside of the U.S..

Roche Secures Covid-19 Treatment In $350 Million Deal With Boston-Based Atea

Basel, 22 October 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Atea Pharmaceuticals, Inc. announced today that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute AT-527, Atea's investigational oral direct-acting antiviral, to people around the globe. AT-527 acts by blocking the viral RNA polymerase enzyme needed for viral replication, and is currently being studied in a Phase 2 clinical trial for hospitalised patients with moderate COVID-19. A Phase 3 clinical trial, expected to start in Q1 2021, will explore the potential use in patients outside of the hospital setting. In addition, AT-527 may be developed for post-exposure prophylactic settings. AT-527, while being a potential oral treatment option for hospitalised patients, also holds the potential to be the first oral treatment option for COVID-19 patients that are not hospitalised.  Additionally, the manufacturing process of small-molecule DAAs allows the ability to produce large quantities of a much needed treatment. If successful, AT-527 could help treat patients early, reduce the progression of the infection, and contribute to decreasing the overall burden on health systems. The collaboration aims to accelerate the clinical development and manufacturing of AT-527, to investigate its safety and efficacy, and to provide this potential treatment option to patients around the world as quickly as possible. If AT-527 proves safe and effective in clinical trials and regulatory approvals are granted, Atea will be responsible for distributing this treatment option in the U.S, with the option to request Genentech's support, and Roche will be responsible for distribution outside the United States. "The ongoing complexities of COVID-19 require multiple lines of defence. By joining forces with Atea, we hope to offer an additional treatment option for hospitalised and non-hospitalised COVID-19 patients, and to ease the burden on hospitals during a global pandemic." said Bill Anderson, Chief Executive Officer of Roche Pharmaceuticals. "In jointly developing and manufacturing AT-527 at scale, we seek to make this treatment option available to as many people around the world as we possibly can." “Roche shares our passion for delivering innovative new medicines to address great unmet medical needs. The COVID-19 pandemic has highlighted the urgent need for a novel, oral antiviral to treat this highly infectious and often deadly virus,” said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals. “AT-527 is expected to be ideally suited to combat COVID-19 as it inhibits viral replication by interfering with viral RNA polymerase, a key component in the replication machinery of RNA viruses. Importantly, the manufacturing process for our small molecule direct-acting antiviral allows us to produce AT-527 quickly and at scale.” About AT-527 AT-527 is an investigational, oral, purine nucleotide prodrug, which has demonstrated in vitro and in vivo antiviral activity against several enveloped single-stranded RNA viruses, including human flaviviruses and coronaviruses. This highly selective purine nucleotide prodrug was designed to uniquely inhibit viral RNA dependent RNA polymerase, an enzyme that is essential for the replication of RNA viruses. Antiviral activity and safety of AT-527 has been demonstrated in Phase 2 clinical studies of hepatitis C patients, and in preclinical in-vitro assays with SARS-CoV2 virus.  AT-527 is not yet licensed or approved for any indication in the United States or any other country. About Roche's response to the COVID-19 pandemic As a leading healthcare company we are doing all we can to support countries in minimising the impact of COVID-19.  We have developed a growing number of diagnostic solutions that help to detect and diagnose  the infection in patients, as well as providing digital support to healthcare systems, and we continue to identify, develop and support potential therapies which can play a role in treating the disease. We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future. Our diagnostics solutions: Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Our portfolio includes:

Roche announces collaboration with Atea Pharmaceuticals to develop a potential oral treatment for COVID-19 patients

ROCKVILLE, Md.--(BUSINESS WIRE)--NeoImmuneTech and Roche announce a second clinical collaboration to evaluate NT-I7 and atezolizumab in non-small cell lung cancer.

NeoImmuneTech Announces a Second Clinical Collaboration with Roche to Evaluate NT-I7 (efineptakin alfa) in Combination with PD-L1 checkpoint inhibitor in First-line Non-small Cell Lung Cancer

AbbVie

Roche (RHHBY) and partner AbbVie obtain full FDA approval for leukemia drug, Venclexta, in combination with Vidaza or Dacogen or low-dose cytarabine (LDAC).

Roche (RHHBY), AbbVie's Leukemia Drug Venclexta Get Full FDA Nod

              Basel, 19 October 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has granted full approval of Venclexta® (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta was previously granted provisional approval in this setting under the FDA's accelerated approval programme in November 2018. Today's FDA approval converts Venclexta's accelerated approval in this setting to a full approval. “Today's full approval is supported by the significant results that showed that Venclexta in combination with azacitidine extended overall survival for people with newly diagnosed acute myeloid leukaemia who cannot tolerate intensive induction chemotherapy,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We are very pleased that this application was reviewed under the FDA's Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this treatment option more rapidly to patients in the United States and other countries.” The approval is primarily based on the results of two phase III studies, VIALE-A and VIALE-C. Results of the VIALE-A study, which were published in the New England Journal of Medicine in August 2020, showed Venclexta plus azacitidine significantly reduced the risk of death by 34% (overall survival; OS) compared to azacitidine alone (median OS=14.7 months vs. 9.6 months; HR=0.66; 95% CI: 0.52-0.85; p

Roche announces full FDA approval for Venclexta combinations for acute myeloid leukaemia

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted full approval of Venclexta® (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta wa

Genentech Announces Full FDA Approval for Venclexta Combinations for Acute Myeloid Leukemia

Revenge Of The Clones: Roche Takes A Hit From Biosimilars, But Worthwhile Value Remains

Roche Holding AG (RHHBY) CEO Severin Schwan on Q3 2020 Results - Earnings Call Transcript

Shares of Roche GS (SIX: ROG) fell 3.49% today after the Swiss drugmaker reported lower-than-expected drug sales.  Fundamental analysis: Covid-19 helping sales Roche said that increased demand for coronavirus tests helped elevate its Q3 revenues and compensate for plummeting drug sales.

Roche stock price hits a 6-month low as drug sales miss estimates

Roche's (RHHBY) performance in the first nine months gets negatively impacted by coronavirus-related disruptions. Nevertheless, the diagnostics division maintains momentum.

Roche's (RHHBY) 9M20 Sales Affected by COVID-19 Outbreak

Roche said any lingering affects of a logistics glitch in Britain should be "cleared out" by the weekend, after the Swiss drugmaker delivered 80 tonnes of diagnostics equipment to the National Health Service (NHS) to help solve the problem.

Roche sees problems from warehouse glitch in Britain 'cleared out' by weekend

Few people like talking about cancer, but with 20/20 GeneSystems stock investors have a chance to profit off its mass-scale mitigation. The post Improve the Fight Against Cancer with 20/20 GeneSystems Stock appeared first on InvestorPlace.

Improve the Fight Against Cancer with 20/20 GeneSystems Stock

Commenting on the Group’s sales in the first nine months, Roche CEO Severin Schwan said: “Roche is at the forefront of the fight against COVID-19 with a growing portfolio of diagnostics solutions, the development of new medicines and a number of partnerships across the industry. With the recent launch of the rapid antigen test, we further strengthened our position as a leading supplier of COVID-19 tests. At the same time, we continue to deliver solutions for patients suffering from other severe diseases. I am particularly pleased about the FDA approvals in the third quarter for three new medicines: Enspryng and Evrysdi for rare diseases, and the cancer medicine Gavreto. After the pandemic-related decline in the second quarter, sales stabilised in the third quarter due to continued strong demand for our new medicines and COVID-19 tests. Based on our current assessment, we confirm the outlook for the full-year.” Roche’s contributions to the fight against the COVID-19 pandemic in the third quarter:

First nine months of the year with 1% sales growth at constant exchange rates, significant impact of COVID-19 pandemic

              Basel, 13 October 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it intends to launch a high-volume SARS-CoV-2 Antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. The test is planned to be made available at the end of 2020 for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA). The Elecsys® SARS-CoV-2 Antigen test is a highly accurate laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of SARS‑CoV‑2. The test is performed by healthcare professionals and uses nasopharyngeal or oropharyngeal swab samples from patients with signs and symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2. The Elecsys SARS-CoV-2 Antigen immunoassay runs on all cobas e immunochemistry analysers which are widely available around the world. These fully automated systems can provide test results in 18 minutes for a single test (excluding time for sample collection, transport, and preparation), with a throughput of up to 300 tests per hour from a single analyser, depending on the analyser1. A laboratory based automated antigen assay allows for cost and error reduction due to removal of manual handling as well as fast turn-around times and high test throughput. Thomas Schinecker, CEO Roche Diagnostics, stated, “We are aware that governments and healthcare systems are under intense pressure to increase SARS-CoV-2 testing capacity to effectively manage the spread of the virus. A high-volume antigen test is a valuable addition to the testing portfolio for helping diagnose SARS-CoV-2 infection. Being able to quickly and correctly identify if someone has a SARS-CoV-2 infection is critical to informing patient management decisions and containing the spread of COVID-19. Roche remains committed to supporting governments, healthcare professionals and patients to fight this pandemic with the help of our diagnostics solutions.” The test will be another addition to the comprehensive Roche diagnostic portfolio of solutions to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. These solutions include both tests to detect an acute SARS-CoV-2 infection and tests measuring the body’s immune response upon infection or vaccination. The following table provides an overview of Roche’s current COVID-19 test portfolio for the detection of an acute SARS-CoV-2 infection or immune response:

Roche to launch laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients

British American Tobacco

Nestle SA

Novo Nordisk

Novartis

SAP SE

Sanofi

Unilever

Vanguard FTSE Developed Markets ETF

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10 Best European Stocks for an Income-Rich Recovery

Veeva Systems

BARCELONA, Spain--(BUSINESS WIRE)-- #lifesciences--Roche selects Veeva Vault applications across clinical, regulatory, and quality.

Roche Selects Veeva Development Cloud Applications

NAARDEN, The Netherlands & BRIGHTON, England--(BUSINESS WIRE)--Forbion portfolio company, Enterprise Therapeutics’ novel TMEM16A potentiator portfolio has been fully acquired by Roche.

Forbion Portfolio Company, Enterprise Therapeutics’ First-in-Class TMEM16A Potentiator Program for Treatment of Cystic Fibrosis and Other Respiratory Diseases Acquired by Roche

BRIGHTON, England--(BUSINESS WIRE)--Enterprise Therapeutics’ First-in-Class TMEM16A potentiator program for treatment of cystic fibrosis and other respiratory diseases acquired by Roche

News for Roche Holding AG Stock (RHHBY)