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

September 1, 2020 Acad, Gov/Utilities Bio/Pharma/CRO Microscopy PR/Corporate

Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS

Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management of patients with HIV – from appropriate counseling on disease differences to targeted therapy Supports rapid molecular detection of acute HIV infection, which is critical in curbing further disease transmission Combines confirmatory HIV testing and HIV-1/HIV-2 differentiation into... Read more

August 28, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

Roche announces FDA approval of FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test

FoundationOne Liquid CDx analyses more than 300 cancer-related genes and multiple genomic signatures to help inform treatment decisions for all solid tumour cancers Using a simple blood draw, the test allows more patients with advanced cancer to benefit from the insights of comprehensive genomic profiling, for example when a tissue biopsy is not possible or... Read more

August 19, 2020 Uncategorized

Roche and Regeneron collaborate to significantly increase global supply of REGN-COV2 investigational antibody combination for COVID-19

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. The companies will collaborate on developing and manufacturing REGN-COV2. Regeneron will distribute REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S. Under this collaboration, the overall capacity of REGN-COV2 is expected to... Read more