Roche ’s Evrysdi (risdiplam) granted FDA priority review for treatment of pre-symptomatic babies under two months of age with spinal muscular atrophy (SMA)
Interim data submitted to the FDA show majority of pre-symptomatic babies treated withEvrysdi for at least one year were able to sit, stand and walk within timeframes typical of healthy babies, as well as maintain swallowingEvrysdi is approved in 70 countries and submitted in a further 31 with more than 4,500 patients treated to dateBasel, 25 January 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of a supplemental new drug application (sNDA) for the use of Evrysdi® (risdiplam) to treat pre-symptomatic babies under two months of age w...
Source: Roche Media News - January 25, 2022 Category: Pharmaceuticals Source Type: news
Roche ’s Evrysdi (risdiplam) granted FDA priority review for treatment of pre-symptomatic babies under 2 months of age with spinal muscular atrophy (SMA)
Basel, 25 January 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of a supplemental new drug application (sNDA) for the use of Evrysdi® (risdiplam) to treat pre-symptomatic babies under two months of age with spinal muscular atrophy (SMA). The sNDA submission incorporates interim data from the RAINBOWFISH study, which shows the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting, standing, walking and maintained the ability to swallow following 12 months of treatment. “Treating very youn...
Source: Roche Media News - January 25, 2022 Category: Pharmaceuticals Source Type: news
The Lancet publishes studies showing Roche ’s faricimab improved and maintained vision in two leading causes of vision loss, extending time between treatments up to four months
Two papers in The Lancet highlight one-year results from Roche ’s phase III trials evaluatingfaricimab inneovascular or “wet” age-related macular (nAMD) and diabetic macular edema (DME)Across four studies, about half of eligiblefaricimab patients were able to go four months between treatments, and approximately three-quarters could be treated every three months or longerReductions in central subfield thickness (CST) and resolution ofintraretinal fluid consistentlyfavouredfaricimab overaflibercept in DME, and meaningful and comparable CST reductions were seen innAMD in the first yearBasel, 24 January 2022 - Roche (SIX...
Source: Roche Media News - January 24, 2022 Category: Pharmaceuticals Source Type: news
The Lancet publishes studies showing Roche ’s faricimab improved and maintained vision in two leading causes of vision loss, extending time between treatments up to four months
Basel, 24 January 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that The Lancet has published two papers highlighting one-year results from four pivotal phase III studies of faricimab, an investigational bispecific antibody, in neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). [1,2] All four studies – which enrolled more than 3,000 people in total – met their primary endpoints, showing that people treated with faricimab up to every four months achieved non-inferior vision gains compare d to aflibercept given every two months. Notably, about half of eligible f...
Source: Roche Media News - January 24, 2022 Category: Pharmaceuticals Source Type: news
Roche launches the cobas ® pulse system, an industry first professional blood glucose management solution with mobile digital health capabilities to improve patient care
Rochelaunches thecobas® pulse system, an industry first professional blood glucose management solution with mobile digital health capabilities to improve patient careHandheld blood glucose management device designed around the specific needs of healthcare professionals working in a range of care settingsFirst diagnostic solution at the point of care to serve as a digital platform connecting developers of digital health software and applications to healthcare professionalsNew system simplifies workflows and equips healthcare professionals with valuable clinical insights to deliver better patient careBasel, 12 January 2022 ...
Source: Roche Media News - January 12, 2022 Category: Pharmaceuticals Source Type: news
Roche launches the cobas ® pulse system, an industry first professional blood glucose management solution with mobile digital health capabilities to improve patient care
Rochelaunches thecobas® pulse system, an industry first professional blood glucose management solution with mobile digital health capabilities to improve patient care (Source: Roche Media News)
Source: Roche Media News - January 12, 2022 Category: Pharmaceuticals Source Type: news
Roche introduces cobas infinity edge, a new open digital ecosystem for point of care professionals, driving improved patient outcomes and operational efficiencies in healthcare
Roche ’s new cloud-based platform connects patient test results, medical records and third-party applications, allowing professionals to monitor patients’ health, adjust treatment protocols, and make quick data-driven patient care decisions anytime, anywhere within and across clinical settings.The new digitalecosystem breaks down common information silos for point of care (POC) professionals, reducing costs and administrative burdens by connecting information securely and compliantly across devices, providers, and locations.Cobas® infinity edge is designed as an open platform, allowing healthcare professionals to easi...
Source: Roche Media News - January 11, 2022 Category: Pharmaceuticals Source Type: news
Roche introduces cobas infinity edge, a new open digital ecosystem for point of care professionals, driving improved patient outcomes and operational efficiencies in healthcare
Basel, 11 January 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today introduced cobas ® infinity edge, a secure and encrypted cloud-based platform for the integration and management of point of care data, available for use in clinical settings globally.More people are using digital technologies in health than ever before. Only 15% of healthcare organisations are fully equipped to make quick data-driven decisions due to lack of data integration, multiple incompatible IT systems, and other information silos. With longer life expectancies, and more people living with chronic conditions, healthcare systems face growing pressure ...
Source: Roche Media News - January 11, 2022 Category: Pharmaceuticals Source Type: news
Roche COVID-19 At-Home Test granted FDA Emergency Use Authorization to expand access to rapid self-testing solutions in the United States
Rapid test to support the American public ’s fight against the COVID-19 pandemic, with availability to purchase over-the-counter (OTC) at pharmacies and retailers nationwideThe COVID-19 At-Home Test uses a simple nasal swab sample to enable individuals to self-test at home and receive accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron.EUA granted through Roche ’s participation in the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Independent Test Assessment Program to bring rapid tests to the OTC marketBasel, 24 ...
Source: Roche Media News - December 24, 2021 Category: Pharmaceuticals Source Type: news
Roche COVID-19 At-Home Test granted FDA Emergency Use Authorization to expand access to rapid self-testing solutions in the United States
Basel, 24 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its COVID-19 At-Home Test. ¹ The test uses a simple anterior nasal swab sample that can be conveniently self-collected and self-tested by individuals aged 14 years and older, and by an adult for children aged 2-13 years old.² The test is able to produce accurate, reliable and quick results in as few as 20 minutes for SARS-C oV-2 and all known variants of concern, including Omicron. (Source: Roche Media News)
Source: Roche Media News - December 24, 2021 Category: Pharmaceuticals Source Type: news
Roche ’s Polivy combination reduced the risk of disease worsening or death by 27% in people with previously untreated aggressive form of lymphoma
Basel, 14 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the phase III POLARIX study showing that treatment with Polivy ® (polatuzumab vedotin) in combination with MabThera®/Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) significantly reduced the risk of disease progression, relapse or death (progression-free survival; PFS) by 27% compared with the current standard-of-care, MabThera /Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Safety outcomes wer...
Source: Roche Media News - December 14, 2021 Category: Pharmaceuticals Source Type: news
Roche launches the AVENIO Edge System to simplify and automate next-generation sequencing sample preparation, reduce human error and advance precision medicine
Basel, 13 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the AVENIO Edge System, a core component of Roche ’s strategy to advance sequencing technologies. Built on best-in-class foundational capabilities to deliver a fully-automated, integrated sequencing solution.The AVENIO Edge System is a pre-analytical platform for sequencing library preparation, target enrichment and quantification steps that deliver integrated, end-to-end control with reliable, consistent high-quality results.“Roche is committed to developing diagnostic solutions with the goal of providing the healthcare communit...
Source: Roche Media News - December 13, 2021 Category: Pharmaceuticals Source Type: news
Interim data from phase III HAVEN 6 study demonstrate favourable safety and efficacy profile of Roche ’s Hemlibra in people with moderate or mild haemophilia A
Basel, 13 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from an interim analysis of the phase III HAVEN 6 study, which show Hemlibra ® (emicizumab) demonstrated a favourable safety profile and effective bleed control in people with moderate or mild haemophilia A without factor VIII inhibitors.3 The data were presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition as an oral presentation on 12 December 2021. (Source: Roche Media News)
Source: Roche Media News - December 13, 2021 Category: Pharmaceuticals Source Type: news
Roche presents pivotal data at ASH 2021 for novel cancer immunotherapy mosunetuzumab
Basel, 11 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new pivotal data on its CD20xCD3 T-cell engaging bispecific antibody, mosunetuzumab, will be presented for the first time at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition from 11-14 December 2021. (Source: Roche Media News)
Source: Roche Media News - December 11, 2021 Category: Pharmaceuticals Source Type: news
New data from the phase II CITYSCAPE trial show encouraging results with Roche ’s novel anti-TIGIT tiragolumab plus Tecentriq
Basel, 10 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new follow-up efficacy, safety and patient-reported outcomes (PROs) data from the phase II CITYSCAPE trial, investigating the novel anti-TIGIT cancer immunotherapy tiragolumab plus Tecentriq ® (atezolizumab) compared with Tecentriq alone as an initial (first-line) treatment for people with PD-L1-positive metastatic non-small cell lung cancer (NSCLC). The full results are being featured as an oral presentation in the Proffered Paper session 2 (Abstract LBA2) at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2021, taking ...
Source: Roche Media News - December 10, 2021 Category: Pharmaceuticals Source Type: news
