September 17, 2020 Licensing, IP, and Legal

Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020

New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers New integrated analyses from our tumour agnostic Rozlytrek® (entrectinib) clinical development programme Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating GavretoTM(pralsetinib) for the treatment of people with RET-mutant medullary... Read more

September 16, 2020 Acad, Gov/Utilities Bio/Pharma/CRO PAI Top-10 PR/Corporate

Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer

Next-generation biomarker cytology test supports World Health Organization’s goal to eliminate cervical cancer, which is nearly 100 percent preventable with proper screening, vaccination and treatment New indication allows this first FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs More... Read more

September 11, 2020 Licensing, IP, and Legal Product Launch

New data further reinforce Roche’s OCREVUS (ocrelizumab) as a highly effective treatment for people with multiple sclerosis

75% of patients with relapsing-remitting multiple sclerosis (RRMS) and suboptimal response to prior treatment had no evidence of disease activity two years after switching to OCREVUS in open-label Phase IIIb CASTING study 97% persistence and strong adherence to OCREVUS treatment and twice-yearly dosing schedule from real-world data OCREVUS is the first and only treatment approved... Read more

September 10, 2020 Product Launch

New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD)

ENSPRYNG lowered relapse severity in double-blind periods of SAkura Phase III studies. Pooled data from SAkura open-label extension (OLE) studies support continued effect of ENSPRYNG reducing risk of relapse in the longer term Ongoing data continues to show a favourable safety profile for ENSPRYNG ENSPRYNG was recently approved by the U.S. Food and Drug Administration... Read more

September 9, 2020 Clinical Research/Diagn. Licensing, IP, and Legal

Roche expands its multiple sclerosis portfolio with investigational BTK inhibitor fenebrutinib and initiates novel clinical trials for OCREVUS (ocrelizumab)

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS) Phase IIIb clinical trial programme of higher-dose OCREVUS (ocrelizumab) to evaluate impact on reducing disability progression in RMS and PPMS OCREVUS CHIMES... Read more

September 8, 2020 Acad, Gov/Utilities Microscopy PR/Corporate

Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients

Immunocompromised transplant patients are at risk of major complications when infected with BK virus cobas BKV test addresses critical need for hospitals and laboratories to have standardised and comparable results across institutions New Breakthrough Device test expands Roche molecular test menu for transplant patients, enabling simultaneous testing of BK virus with Cytomegalovirus and Epstein-Barr virus... Read more

September 7, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer

Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers Genentech and Blueprint Medicines will co-commercialise Gavreto in the United States FDA also granted Priority Review to Gavreto for the treatment of people with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer              Basel, 7 September 2020 – Roche (SIX:... Read more

September 4, 2020 Acad, Gov/Utilities Liq. Handling & Robotics Microscopy PR/Corporate

Roche receives FDA Emergency Use Authorization for the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems

First commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single sample As COVID-19 and influenza infections can hardly be differentiated based on symptoms, healthcare professionals can confidently provide the right diagnosis and best course of treatment for patients Test for use... Read more

September 3, 2020 Licensing, IP, and Legal Product Launch

Roche to present new data in multiple sclerosis and neuromyelitis optica spectrum disorder at MSVirtual2020

New data further reinforce OCREVUS (ocrelizumab) as a highly effective treatment option offering a favourable and consistent benefit:risk profile, with high treatment persistence and adherence Initiation of Phase IIIb OCREVUS higher dose clinical trial programme and Phase IV study evaluating OCREVUS in minority populations Initiation of Phase III clinical trial programme for fenebrutinib, an investigational... Read more

September 1, 2020 Uncategorized

Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE mark, allowing fast triage decisions at point of care

Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions Antigen test accurately screens individuals with known exposure to infected SARS-CoV-2 patients, providing fast answers regarding their infection status Affordable and small, instrument-free testing kit enables convenient use for healthcare professionals at different point of... Read more