(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
Posted in Business, Healthcare, Industrial, Management, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged adults, allergic reactions, CHILDREN, FDA approval, Levi Garraway, Multiple Foods, Reducing, Roche, Xolair®
(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
(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
(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
Posted in Business, Healthcare, Industrial, Management, News, Science, Switzerland, Technology
Tagged breast cancer, HER2-Positive, Kadcyla, Levi Garraway, Long-Term Survival, Phase III KATHERINE, Prof. Dr. Sibylle Loibl, Roche
(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
(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
Posted in Business, Education, Financial, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged acquisition, Carmot Therapeutics, CT-388, Levi Garraway, metabolic disease, Obesity Treatment, Roche, Thomas Schinecker, USA
(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
Posted in Business, Education, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged diagnosis, Elecsys®, HBeAg Quant Test, Hepatitis B, Matt Sause, monitoring, Roche
(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
(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
Posted in Business, Healthcare, Industrial, Management, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged Elecsys NfL Test, FDA, Matt Sause, multiple sclerosis, Roche
(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
(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
Posted in Business, Environment, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Switzerland
Tagged Evrysdi, Levi Garraway, Pre-Symptomatic SMA Babies, RAINBOWFISH study, Richard Finkel, Roche, wellness
(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
Posted in Business, Healthcare, Industrial, Management, News, Pharma & Biotech, Science, Switzerland
Tagged Alnylam, Hypertension Treatment, partnership, RNAi Therapy, Roche, Teresa Graham, Yvonne Greenstreet MBChB, zilebesiran
(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
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
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
Posted in Healthcare, News, Pharma & Biotech, Switzerland
Tagged atezolizuma, Avastin®, bevacizumab, cancer du foie, Cancer Immunotherapy, carcinome hépatocellulaire à un stade précoce, CHC, early-stage hepatocellular carcinoma, étude IMbrave050, HCC, IMbrave050 study, immunothérapie anticancéreuse, Levi Garraway M.D. Ph.D., liver cancer, Roche, Tecentriq®
(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
Posted in Healthcare, Pharma & Biotech, Science, Switzerland
Tagged CHILDREN, infectious disease, influenza, influenza antiviral drug, Levi Garraway, oseltamivir, prevention, Roche, Xofluza treatment
(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
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
Posted in Healthcare, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged Alzheimer, beta-amyloid, biomarkers t, CT scan, diagnosis, Elecsys AD CSF Abeta42, Elecsys AD CSF assays, FDA, MRI, pTau181 assays, Roche, tau proteins, Thomas Schinecker
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
Posted in Business, Healthcare, Pharma & Biotech, Science, Switzerland, Technology
Tagged Alzheimer, beta-amiloide, biomarcadores t, Diagnóstico, Elecsys AD CSF Abeta42, Elecsys Ensayos AD LCR, Elecsys® beta-amiloide, Elecsys® Phospho-Tau, FDA, patología de Alzheimer, proteínas tau, pTau181 ensayos, resonancia magnética, Roche, Thomas Schinecker, tomografía computarizada
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
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
(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
Posted in Automotive, Aviation & Aerospace, Business, Electronics & Machinery, Industrial, International Trade, Metals and Minerals, News, Technology, United Kingdom
Tagged 3D printing, 3D printing machines, additive manufacturing, AS9100, casting, china manufacturing, CNC machining, Eastern Bell Capital, fabrication, FDM, Haier, Haizol, Hongtai Capital Holdings, Hybrid Racing, ISO13485, ISO9001, Jennifer Grant, manufacturers in China, metal manufacturing, MicroPort, MJF, molding, OEM, plastic manufacturing, prototyping, Roche, Rocker, Siemens, SLA, SLS, Stala Capital, stamping, Whirlpool, Woofoo Capital, ZEISS
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
Posted in Healthcare, Non Profit, Pharma & Biotech, Switzerland
Tagged acute bleeds, Bill Anderson, bleeding disorders, Cesar Garrido, Chugai, Dr Osamu Okuda, Haemophilia A, Humanitarian Aid Program, prophylactic treatment, prophylaxis, Roche, WFH Humanitarian Aid Program, World Federation of Hemophilia
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
Posted in News
Tagged acute bleeds, Bill Anderson, bleeding disorders, Cesar Garrido, Chugai, Dr Osamu Okuda, Dr. Osamu Okuda, Federación Mundial de Hemofilia, Haemophilia A, hemofilia A, hemorragias agudas, Humanitarian Aid Program, profilaxis, Programa de ayuda humanitaria, Programa de ayuda humanitaria de la FMH, prophylactic treatment, prophylaxis, Roche, trastornos hemorrágicos, tratamiento profiláctico, WFH Humanitarian Aid Program, World Federation of Hemophilia
(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
Posted in Artificial Intelligence (AI), Denmark, France, Healthcare, News, Pharma & Biotech, Science, Spain, Technology
Tagged Accu-Chek Insight, AI, aid, artificial-intelligence, ATTD 2022, automated insulin delivery, biphasic boluses, blood sugar level, DBL-hu, DBLG1, DBLG1 iController, DBLG1 System, Diabeloop, Diabetes, diabetes management, Erik Huneker, glucose control, glycemic control, HbA1c, Insulin Pump, postprandial hyperglycemia, Prof. Pierre-Yves Benhamou, real-life DBLG1 cohort, reduction of hypoglycemia, reduction of hypoglycemic episodes, Roche, Stéphanie JEGU, T1D, Time In Range, TIR, type 1 diabetes, WP7, WP72 study, YourLoops
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
Posted in Healthcare, News, Pharma & Biotech, Switzerland
Tagged affections rétiniennes, angiogenèse, anticorps bispécifique, DME, DMLA néovasculaire, exsudation et dégénérescence 2022, injections oculaires, Levi Garraway MD Ph.D., médecine oculaire, perte de vision, ranibizumab, RHIN, Roche, Susvimo, Susvimo Archway, Vabysmo, YOSEMITE, œdème maculaire diabétique
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
Posted in Healthcare, News, Pharma & Biotech, Switzerland
Tagged Angiogenesis, bispecific antibody, diabetic macular edema, DME, Exudation and Degeneration 2022, eye injections, eye medicine, Levi Garraway M.D. Ph.D., Neovascular AMD, ranibizumab, retinal conditions, RHINE, Roche, Susvimo, Susvimo Archway, Vabysmo, vision loss, YOSEMITE
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
Posted in Healthcare, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged American Society of Hematology, ASH, bleeding, blood clotting, blood disease, Chugai, Chugai Pharmaceutical, diagnostics, emicizumab, Genentech, haemophilia, Haemophilia A, HAVEN 6, Hemlibra®, Levi Garraway, pharmaceuticals, pharmacodynamics, pharmacokinetics, phase III HAVEN 6 study, prophylactic, Roche
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
Posted in Healthcare, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged advance sequencing technologies, AVENIO Edge System, diagnostic solutions, diagnostics, In Vitro Diagnostics, integrated sequencing, IVD, next-generation sequencing, NGS, Roche, sequencing library preparation, Thomas Schinecker
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
Posted in Healthcare, News, Pharma & Biotech, Switzerland, Technology
Tagged biomarker, cervical cancer, cervical cells, cervical pre-cancers, CINtec PLUS Cytology, Colposcopy Triage, HPV, HPV-positive women, human papillomavirus, impact, International Journal of Cancer, Pap cytology, Roche, testing
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
Posted in Artificial Intelligence (AI), France, Healthcare, Italy, News, Pharma & Biotech, Science, Spain, Technology
Tagged ACCU-CHEK, Accu-Chek Insight, algorithm, artificial-intelligence, Automated Insulin Delivery system, CE certificate, CGM, continuous glucose monitor, data, data visualization platform, DBLG1, DBLG1 System, Dexcom, Dexcom G6, Diabeloop, Diabetes, EASD 2021, Erik Huneker, glucose, HbA1c, Hypoglycemia, Insulin Pump, Pr. Pierre-Yves Benhamou, Roche, Stéphanie JEGU, T1D, therapeutic artificial intelligence, therapeutic artificial intelligence for diabetes management, Time In Range, TÜV Rheinland, type 1 diabetes, YourLoops
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
Posted in Healthcare, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged DMD, Duchenne muscular dystrophy, Endeavor, Evrysdi, gene therapy, Hammersmith Infant Neurological Examination, HINE-2, Levi Garraway, M.D. Ph.D, motor milestones, neuromuscular, RAINBOWFISH study, risdiplam, Roche, Sarepta, SMA, spinal muscular atrophy, SRP-9001, World Muscle Society (WMS) Virtual Congress
(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
Posted in Automotive, Aviation & Aerospace, Business, Industrial, International Trade, News, United Kingdom
Tagged casting, CNC machining, component assembly, consulting, custom part manufacturing, design, digital, distributors, Eastern Bell Capital, end to end manufacturing services, engineering manufacturing, fabrication, Haier, Haizol, Hongtai Capital Holdings, Hybrid Racing, industrial data, injection molding, interactive digital platform, Jennifer Grant, machine parts, Manufacturing, manufacturing processes, metal, MicroPort, molding, Outsourcing, patent creators, plastic, Product Development, project management, prototyping, Roche, Rocker, Siemens, sourcing, Stala Capital, stamping, Startups, subcontractors, suppliers in China, system integrators, user friendly portal, value-added resellers, Whirlpool, Woofoo Capital, ZEISS
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
Posted in Healthcare, Marketing, News, Pharma & Biotech, Switzerland
Tagged atezolizumab, Cancer Immunotherapy, chemotherapy, FDA, Levi Garraway, lung cancer, non-small cell lung cancer, NSCLC, Real-Time Oncology Review, Roche, sBLA, supplemental Biologics License Application, Tecentriq®, treatment, tumours
(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
Posted in Germany, Healthcare, Management, News, Pharma & Biotech, Technology
Tagged Amgen Inc., Bayer AG, Biomarker Development, Blinatumumab, Blincyto, Dominik Ruettinger, Dr. Christian Rommel, Early Clinical, Micromet Inc., oncology, pharmaceuticals, pRED, Prof. Dr. Dominik Ruettinger, RESEARCH, Roche, Surgical Oncology, therapeutic development, translational clinical research, tumor, tumor immunology, University of Munich
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
Posted in Healthcare, News, Pharma & Biotech, Switzerland
Tagged Anti-SARS-CoV-2 S, antibodies, antibody test, COVID-19, Elecsys Anti-SARS-CoV-2 S test, Elecsys Anti-SARS-CoV-2 serology test, Elecsys®, Emergency Use Authorisation, EUA, FDA, Roche, SARS-CoV-2, SARS-CoV-2 vaccine, Thomas Schinecker, vaccines
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
Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved for the treatment of unresectable or metastatic hepatocellular carcinoma Tecentriq combination improved overall survival and progression-free survival compared to the previous standard of care Application approved … Read the full press release
First clinical data from tiragolumab, Roche’s novel anti-TIGIT cancer immunotherapy, in combination with Tecentriq® (atezolizumab) in patients with PD-L1-positive metastatic non-small cell lung cancer (NSCLC) Updated overall survival data for Alecensa® (alectinib), in people living with anaplastic lymphoma kinase (ALK)-positive … Read the full press release
Posted in Healthcare, Pharma & Biotech, Science, Switzerland
Tagged Alecensa®, alectinib, anaplastic lymphoma kinase, ASCO virtual newsroom, ASCO20 Virtual Scientific Program, atezolizumab, cancer care, Cancer Immunotherapy, clinical data tiragolumab, Levi Garraway M.D. Ph.D., lung cancer, Roche, Tecentriq®
Baloxavir marboxil – an investigational oral, single-dose antiviral – is the first flu medicine with a novel proposed mechanism of action in nearly 20 years and to demonstrate significant efficacy in high-risk patients Influenza, or “flu,” represents a serious threat … Read the full press release
Posted in Healthcare, Pharma & Biotech, Switzerland
Tagged baloxavir marboxil, flu, influenza, Roche, Sandra Horning
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PHARMA & BIOTECH: The largest repository of EU/European pharma & biotech press releases spanning 12 years (2012-2024)
