Tag Archives: Roche

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

Liver cancer: Roche’s Tecentriq in combination with Avastin approved by US FDA

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

ASCO20 Virtual Scientific Program: Roche to present new data from clinical trials of approved and investigational medicines across 21 cancer types

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

Roche’s phase III CAPSTONE-2 study showed superior efficacy of baloxavir marboxil in reducing influenza symptoms in people at high risk of complications from the flu

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

Roche’s Tecentriq in combination with Avastin receives FDA Breakthrough Therapy Designation as initial treatment for advanced or metastatic hepatocellular carcinoma

BASEL, 18-Jul-2018 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as an initial (first-line) treatment for people with advanced … Read the full press release

Roche: US FDA granted Breakthrough Therapy Designation to Hemlibra® for people with haemophilia A without factor VIII inhibitors

Designation based on phase III HAVEN 3 study demonstrating Hemlibra prophylaxis significantly reduced bleeds compared to no prophylaxis First medicine to show superior efficacy compared to prior factor VIII prophylaxis in an intra-patient comparison BASEL, 19-Apr-2018 — /EuropaWire/ — Roche … Read the full press release

Roche: Phase III IMpower131 study met its co-primary endpoint of progression-free survival of people with a type of advanced squamous lung cancer

BASEL, 20-Mar-2018 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpower131 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane [albumin-bound … Read the full press release

Shire CMO Howard Mayer, M.D.: no patient is currently being denied access to treatment with Hemlibra

DUBLIN, 16-Jan-2018 — /EuropaWire/ — At Shire, we’ve been committed to the hemophilia community and the lives of every patient afflicted with this disease for more than 70 years. We are very proud of this legacy and take our role as … Read the full press release

Roche to fully acquire Ignyta for US$ 1.7 billion in an all-cash transaction

Roche to acquire Ignyta for US$ 27.00 per share Ignyta’s investigational medicine entrectinib, a selective CNS-active tyrosine-kinase inhibitor being developed for tumours that harbor ROS1 or NTRK fusions, to expand Roche’s portfolio of oncology medicines BASEL, 27-Dec-2017 — /EuropaWire/ — … Read the full press release

Roche study combining Esbriet and nintedanib treatment: majority of the patients tolerated the combination treatment

New study combining Esbriet (pirfenidone) and nintedanib showing similar safety profile for the combination treatment to that expected for each treatment alone A second, retrospective, post-hoc, analysis suggests that treatment with Esbriet may be associated with a reduction of multiple … Read the full press release

Roche phase III BRIM8 study: 46% reduction in recurrence risk was observed in stage IIC-IIIB melanoma patients

BASEL, 14-Sep-2017 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced data for the phase III BRIM8 study, which was designed to investigate the efficacy and safety of Zelboraf® (vemurafenib) in the adjuvant (after surgery) treatment of people with … Read the full press release

Haemophilia A: data from Roche’s HAVEN 1 published in The New England Journal of Medicine (NEJM)

Positive phase III results for Roche’s emicizumab in haemophilia A published in The New England Journal of Medicine HAVEN 1 showed emicizumab reduced bleed rate by 87% compared with on-demand bypassing agents All 12 secondary endpoints in HAVEN 1 were … Read the full press release

Roche’s Lucentis is the first and only FDA-approved medicine to treat diabetic retinopathy

First and only medicine approved to treat all forms of diabetic retinopathy Granted Priority Review Designation by the FDA based on analysis of results from a National Institutes of Health (NIH)-funded collaborative group study BASEL, 24-Apr-2017 — /EuropaWire/ — Roche (SIX: … Read the full press release

FDA Approves Roche’s TECENTRIQ as initial treatment for certain advanced bladder cancer patients

First and only cancer immunotherapy approved in advanced bladder cancer as initial treatment for those unable to receive cisplatin chemotherapy BASEL, 24-Apr-2017 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) … Read the full press release

New Data on Roche’s OCREVUS To be Presented at AAN

Data presentations will include platform sessions and posters across relapsing multiple sclerosis and primary progressive multiple sclerosis BASEL, 24-Apr-2017 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data on OCREVUS™ (ocrelizumab) in people with relapsing … Read the full press release

Roche to present 60 abstracts featuring nine of its approved or investigational medicines at the 58th American Society of Hematology (ASH) in San Diego

New results from the phase III GALLIUM study which compared Gazyva/Gazyvaro (obinutuzumab) plus chemotherapy to Rituxan/ MabThera (rituximab) plus chemotherapy in previously untreated follicular lymphoma will be presented in the Plenary Scientific Session New results for Venclexta/Venclyxto(venetoclax) and investigational medicine … Read the full press release