Tag Archives: Roche

Roche Launches Advanced Diagnostic Test for B-Cell Lymphoma Detection

(IN BRIEF) Roche has introduced the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, the first clinically approved in-situ hybridisation (ISH) test of its kind. Designed to enhance sensitivity in diagnosing B-cell lymphoma, the assay helps differentiate cancerous … Read the full press release

Roche Announces Retirement of Head of Pharma Partnering and Successor Appointment

(IN BRIEF) Roche (SIX: RO, ROG; OTCQX: RHHBY) reveals the retirement of James Sabry, the Head of Roche Pharma Partnering, after fourteen years of service. Effective 1 July 2024, Boris Zaïtra, currently Head of Group Business Development, will take on … Read the full press release

Roche and Amgen Collaborate on Breakthrough Lp(a) Test for Cardiovascular Disease Risk

(IN BRIEF) Roche Diagnostics has announced that its Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). Developed in collaboration with Amgen, this innovative test aims to identify individuals at risk … Read the full press release

Roche’s Xolair Nears FDA Approval for Reducing Allergic Reactions to Multiple Foods

(IN BRIEF) Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) under Priority Review. The sBLA is for the reduction of allergic reactions, including anaphylaxis, caused by … Read the full press release

Roche Achieves Top Sustainability Rankings in Pharmaceuticals Index for 15th Consecutive Year

(IN BRIEF) Roche (SIX: RO, ROG; OTCQX: RHHBY) has once again secured its position as one of the leading sustainable companies in the Pharmaceuticals sector within the Dow Jones Sustainability Indices (DJSI). In the latest rankings, Roche secured the third … Read the full press release

Roche Presents Promising Data on Innovative Lymphoma Treatments at ASH Annual Meeting

(IN BRIEF) Roche, a global pharmaceutical company, has shared compelling data from its CD20xCD3 T-cell engaging bispecific antibody program during the 65th American Society of Hematology (ASH) Annual Meeting & Exposition held in December 2023. The data includes extended follow-up … Read the full press release

Roche’s Kadcyla Demonstrates Long-Term Survival Benefit in HER2-Positive Early Breast Cancer

(IN BRIEF) Roche has released positive long-term follow-up data from the Phase III KATHERINE study, evaluating Kadcyla® (trastuzumab emtansine) as adjuvant therapy for people with HER2-positive early-stage breast cancer (eBC) who have residual invasive disease following neoadjuvant treatment. The study … Read the full press release

Roche Reports Positive Phase III Results for Inavolisib Combination Therapy in PIK3CA-Mutated Breast Cancer

(IN BRIEF) Roche has announced promising results from the Phase III INAVO120 study, which evaluated inavolisib in combination with palbociclib (Ibrance®) and fulvestrant as a first-line treatment for individuals with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced, or metastatic … Read the full press release

Roche to Acquire Carmot Therapeutics for USD 2.7 Billion, Expanding Its Portfolio in Obesity Treatment

(IN BRIEF) Roche, a leading pharmaceutical company, has announced its definitive merger agreement to acquire Carmot Therapeutics, a privately owned US-based company specializing in obesity treatment and related metabolic diseases. The acquisition includes Carmot’s portfolio of clinical stage subcutaneous and … Read the full press release

Roche Introduces Elecsys® HBeAg Quant Test for Accurate Hepatitis B Diagnosis and Monitoring

(IN BRIEF) Roche has unveiled Elecsys® HBeAg quant, a new immunoassay designed to detect the presence and quantity of the hepatitis B e antigen (HBeAg) in human serum and plasma. This diagnostic tool simplifies the process for both clinicians and … Read the full press release

Roche Launches HEV Infection Detection Tests to Support Global Disease Management

(IN BRIEF) Roche has introduced the Elecsys®Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for detecting hepatitis E virus (HEV) infections in regions accepting the CE mark. These tests aim to assist clinicians in diagnosing the cause of patients’ symptoms, determining … Read the full press release

Roche’s Elecsys NfL Test for Multiple Sclerosis Earns Breakthrough Device Designation from FDA

(IN BRIEF) Roche, a leading healthcare company, has announced that its Elecsys Neurofilament Light Chain (NfL) test for Multiple Sclerosis (MS) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The Elecsys NfL test is designed … Read the full press release

Roche’s OCREVUS Subcutaneous Injection Shows Promise in Phase III Study for Multiple Sclerosis Treatment

(IN BRIEF) Roche has announced positive late-breaking data from the Phase III OCARINA II study, which demonstrates the effectiveness of OCREVUS as a twice-yearly, 10-minute subcutaneous injection for patients with relapsing or primary progressive multiple sclerosis (RMS or PPMS). The … Read the full press release

Roche’s Evrysdi Shows Promise in Pre-Symptomatic SMA Babies, Potentially Changing the Course of the Disease

(IN BRIEF) Roche has reported positive outcomes from the RAINBOWFISH study, an investigation into the efficacy and safety of Evrysdi® (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA). The study, which included 26 infants aged from birth to six … Read the full press release

Roche and Alnylam Partner to Develop Promising RNAi Therapy for Hypertension Treatment

(IN BRIEF) Roche and Alnylam have entered into a partnership to jointly develop and commercialize zilebesiran, an investigational RNAi therapeutic for the treatment of hypertension. Hypertension affects a significant number of adults worldwide and is a major risk factor for … Read the full press release

Roche and Eli Lilly join forces to improve Alzheimer’s diagnosis

(IN BRIEF) Roche has announced a collaboration with Eli Lilly to support the development of its Elecsys Amyloid Plasma Panel (EAPP) which is an innovative blood test that aims to facilitate the earlier diagnosis of Alzheimer’s disease. The EAPP test … Read the full press release

Roche’s Tecentriq and Avastin Combination Offers New Hope for Early-Stage Liver Cancer Patients

Ad hoc announcement pursuant to Art. 53 LR (PRESS RELEASE) BASEL, 19-Jan-2023 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY), a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives, announced that their combination treatment … Read the full press release

L’association Tecentriq et Avastin de Roche offre un nouvel espoir aux patients atteints d’un cancer du foie à un stade précoce

Annonce ad hoc conformément à l’art. 53LR (COMMUNIQUÉ DE PRESSE) BÂLE, 19-Jan-2023 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY), un pionnier mondial des produits pharmaceutiques et des diagnostics axé sur l’avancement de la science pour améliorer la vie des … Read the full press release

Roche’s Xofluza: The Breakthrough Influenza Drug Approved for Children in Europe

(PRESS RELEASE) BASEL, 12-Jan-2023 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY), a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives, has announced that the European Commission has approved Xofluza (baloxavir marboxil), a … Read the full press release

Xofluza de Roche: el fármaco innovador contra la gripe aprobado para niños en Europa

(COMUNICADO DE PRENSA) BASEL, 12-Jan-2023 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY), un pionero mundial en productos farmacéuticos y diagnóstico centrado en el avance de la ciencia para mejorar la vida de las personas, ha anunciado que la … Read the full press release

Roche Diagnostics: Globally, up to 75 percent of people living with Alzheimer’s disease have not been diagnosed

The company announces FDA clearance for its Alzheimer’s disease Cerebrospinal Fluid (CSF) assays The Elecsys® Alzheimer’s disease (AD) CSF assays will be available on the cobas fully automated immunoassay analyzers, enabling patients to get broad access to high quality testing in a timely … Read the full press release

Roche Diagnostics: a nivel mundial, hasta el 75 por ciento de las personas que viven con la enfermedad de Alzheimer no han sido diagnosticadas

La compañía anuncia la aprobación de la FDA para sus ensayos de líquido cefalorraquídeo (LCR) para la enfermedad de Alzheimer Los ensayos Elecsys® para la enfermedad de Alzheimer (EA) en LCR estarán disponibles en los analizadores de inmunoensayo totalmente automatizados … Read the full press release

Roche announces a regulatory milestone for its cobas SARS-CoV-2 Qualitative PCR test for use on the fully automated cobas 6800 and 8800 analyzer systems

The cobas SARS-CoV-2 Qualitative test is one of the first COVID-19 PCR tests performed on an automated, high throughput platform to receive FDA 510(k) clearance. This FDA clearance will ensure that the healthcare community has access to timely, reliable and accurate COVID-19 PCR testing … Read the full press release

Roche annonce une étape réglementaire importante pour son test PCR qualitatif cobas SARS-CoV-2 à utiliser sur les systèmes d’analyseurs cobas 6800 et 8800 entièrement automatisés

Le test qualitatif cobas SARS-CoV-2 est l’un des premiers tests PCR COVID-19 effectués sur une plateforme automatisée à haut débit à recevoir l’autorisation FDA 510(k). Cette autorisation de la FDA garantira que la communauté des soins de santé a accès … Read the full press release

Haizol Now Offer 3D Printing Services to Customers Worldwide

(PRESS RELEASE) LONDON, 6-Jun-2022 — /EuropaWire/ — Haizol launch a new capability to add to their vast array of services, now offering 3D printing to customers worldwide. They have partnered with some of the best manufacturers in China for additive manufacturing to … Read the full press release

Roche extends until 2028 its commitment to the WFH Humanitarian Aid Program aimed at helping people with haemophilia

The renewed commitment will provide continued preventative (prophylactic) treatment to as many as 1,000 people with haemophilia A in locations where there is little to no access to haemophilia treatment Prophylactic treatment aims to prevent bleeds and allow people with haemophilia to achieve quality of life … Read the full press release

Roche extiende hasta 2028 su compromiso con el Programa de ayuda humanitaria de la FMH destinado a ayudar a las personas con hemofilia

El compromiso renovado proporcionará tratamiento preventivo (profiláctico) continuo a hasta 1000 personas con hemofilia A en lugares donde hay poco o ningún acceso al tratamiento de la hemofilia. El tratamiento profiláctico tiene como objetivo prevenir las hemorragias y permitir que las personas … Read the full press release

Diabeloop presents new real-life results of DBLG1® System: Confirmed improvement in Time In Range +18.4 percentage points; Reduction of time spent in hypoglycemia to only 0.9%

(PRESS RELEASE) PARIS, 28-Apr-2022 — /EuropaWire/ — ATTD 2022 – Diabeloop, pioneer in therapeutic artificial intelligence for diabetes management, presents today new results from a real-life cohort in Germany. The data show a constant improvement in Time In Range (70-180 … Read the full press release

Roche présentera de nouvelles données sur deux ans pour ses Vabysmo et Susvimo lors du salon Angiogenesis, Exsudation and Degeneration 2022 le 12 février

Dans les études YOSEMITE et RHINE sur l’œdème maculaire diabétique, au moins 60 % des patients Vabysmo éligibles pourraient prolonger le traitement à tous les quatre mois à deux ans, contre 50 % à la première année Près de 80 % des … Read the full press release

Roche to present new two-year data for its Vabysmo and Susvimo at Angiogenesis, Exudation and Degeneration 2022 on 12 February

In the YOSEMITE and RHINE studies in diabetic macular edema, at least 60% of eligible Vabysmo patients could extend treatment to every four months at two years, compared to 50% at year one Almost 80% of eligible Vabysmo patients could extend treatment to every … Read the full press release

Roche’s announces favourable safety profile and effective bleed control for its Hemlibra in people with moderate or mild haemophilia A without factor VIII inhibitors

People with moderate or mild haemophilia A have significant unmet clinical needs, as this population may not use preventative treatments due to missed or delayed diagnoses of bleeding episodes and a lack of treatment guidelines1,2 New data indicate that Hemlibra has a favourable safety profile in … Read the full press release

Roche announces a further progress in its strategy to advance sequencing technologies

Next-generation sequencing (NGS) enables a better understanding of genetic mechanisms linked to specific diseases and is helping drive personalised healthcare Preparing DNA for sequencing libraries is complex and prone to human error, which can interfere with accurate sequencing results The new AVENIO … Read the full press release

IMPACT trial: Roche’s CINtec PLUS Cytology shows higher sensitivity in detecting cervical pre-cancers in HPV-positive women compared to Pap cytology

Every year, over 604,000 women worldwide are diagnosed with cervical cancer and approximately 342,000 die from this preventable disease, caused by Infection with high-risk human papillomavirus (HPV). As recently published in the International Journal of Cancer, the IMPACT (IMproving Primary screening And Colposcopy … Read the full press release

Significant improvement in increasing Time In Range and reducing hypoglycemia among people equipped with Diabeloop DBLG1

EASD 2021 – Diabeloop, a pioneer in therapeutic artificial intelligence for diabetes management, is presenting new real-world data(1) of its Automated Insulin Delivery system, DBLG1. The personalized device fine-tunes insulin delivery using a state-of-the-art algorithm. Thousands of European patients have … Read the full press release

Spinal muscular atrophy: New data for Evrysdi will be presented by Roche at the World Muscle Society (WMS) Virtual Congress 20 – 24 September 2021

New data show pre-symptomatic babies with spinal muscular atrophy (SMA) treated with Evrysdi maintained the ability to swallow Evrysdi has demonstrated consistent clinically meaningful efficacy in adults, children, and babies two months and older and is now approved in 58 countries worldwide Further … Read the full press release

Haizol, metal manufacturing giant, launch a brand new website which is both user friendly and interactive

(PRESS RELEASE) LONDON, 17-Sep-2021 — /EuropaWire/ — Haizol, an industrial data and engineering manufacturing service, have launched a brand new interactive digital platform. The new site is a user friendly portal where customers can get instant access to quotes for … Read the full press release

Roche on Tecentriq’s US FDA Priority Review grant: New treatment options are urgently needed in early-stage non-small cell lung cancer

Application is being reviewed under the US FDA’s Real-Time Oncology Review pilot programme Based on results of the Phase III IMpower010 study, presented at ASCO, that showed adjuvant Tecentriq improved disease-free survival by more than one-third in PD-L1-positive early-stage lung cancer, compared with … Read the full press release

Prof. Dr. Dominik Ruettinger to lead Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division

(PRESS RELEASE) BERLIN, 26-Jul-2021 — /EuropaWire/ — Bayer, a global enterprise with core competencies in the life science fields of health care and nutrition, has announced that Prof. Dr. Dominik Ruettinger has been appointed as the new Head of Research … Read the full press release

Roche unveils new Anti-SARS-CoV-2 serology test to quantitatively measure antibodies in people exposed to SARS-CoV-2

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test  targets antibodies against the spike protein. This is the focus of vaccines in development … Read the full press release

Roche unveils automated digital pathology algorithm to aid non-small cell lung cancer diagnosis

uPath PD-L1 (SP263) image analysis uses automated pre-computing and one-click scoring to enable quicker and accurate detection and measurement of tumour cell staining positivity Roche advances personalised healthcare with development of image analysis algorithms using artificial intelligence Faster, more accurate … Read the full press release