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Tag: roche

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 […]

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 • […]

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 […]

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 […]

Roche collaborates with Blueprint Medicines to bring a new treatment to people with RET-altered cancers

• Roche will obtain co-development and co-commercialisation rights for pralsetinib, an investigational, precision therapy in late-stage development for people with RET-altered non-small cell lung cancer, various types of thyroid cancer and other solid tumours. • Blueprint Medicines and Roche will collaborate on the development of pralsetinib. • Roche and Blueprint Medicines will co-commercialise pralsetinib in […]

Roche’s IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone met one of its co-primary endpoints

Phase III IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone compared to current standard-of-care (abiraterone and prednisone/prednisolone alone) plus placebo met its co-primary endpoint of radiographic progression free survival (rPFS) in patients with PTEN loss tumours Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III IPATential150 study met its co-primary […]

Roche’s Tecentriq in combination with chemotherapy (including Abraxane) meets primary endpoint of improved pathological complete response

…. regardless of PD-L1 status, as initial treatment for people with early triple-negative breast cancer • IMpassion031 data will be discussed with health authorities globally, including the US Food and Drug Administration and the European Medicines Agency • Tecentriq is the only approved cancer immunotherapy for the treatment of metastatic triple-negative breast cancer, a very […]

Roche announces 2-year risdiplam data from SUNFISH and new data from JEWELFISH in infants, children and adults with spinal muscular atrophy (SMA)

• SUNFISH Part 1 showed risdiplam significantly improved motor function after 24 months of treatment in people aged 2-25 years with Types 2 or 3 SMA • JEWELFISH study preliminary 12 month data in previously treated patients showed rapid and sustained increases in SMN protein levels • Safety in SUNFISH and JEWELFISH was consistent with […]

FDA approves Roche’s Tecentriq in combination with Avastin for people with the most common form of liver cancer

• 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 under FDA’s Project Orbis initiative and Real-Time Oncology Review pilot programme Roche […]

CHMP recommends EU approval of Roche’s Rozlytrek for people with NTRK fusion-positive solid tumours

…..and for people with ROS1-positive, advanced non-small cell lung cancer •Rozlytrek has shown durable responses across multiple tumour types, including cancer that has spread to the brain, and could become Roche’s first tumour-agnostic therapy in Europe Roche (SIX: RO, ROG; OTCQX: RHHBY) announced on May 29th, 2020 that the European Medicines Agency’s (EMA) Committee for […]

Roche’s OCREVUS (ocrelizumab) shorter 2-hour infusion time approved in Europe

• Reduces infusion time to 2 hours from the conventional 3.5 hours for patients with relapsing or primary progressive multiple sclerosis • EMA approval based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional OCREVUS dosing regimen Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced European Medicines Agency (EMA) […]

Roche initiates phase III clinical trial of Actemra/RoActemra plus remdesivir in hospitalised patients with severe COVID-19 pneumonia

Roche is also close to completing enrolment of a global randomised, double-blind, placebo-controlled phase III clinical trial of Actemra®/RoActemra® (tocilizumab) in hospitalised patients with severe COVID-19 pneumonia (COVACTA), with results expected this summer. Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the initiation of a global phase III, randomised, double-blind, multicentre study (REMDACTA) to evaluate […]

Roche acquires Stratos Genomics to further develop DNA based sequencing for diagnostic use

• Genomics insights generated through sequencing an individual’s DNA play a critical role in personalised healthcare and clinical diagnostics of the future • Roche is committed to developing a nanopore sequencer with the aim of providing the healthcare community and ultimately patients with faster and more accurate medical information to predict risk and detect disease […]

New longer-term data reinforce safety of Roche’s satralizumab

…in adults and adolescents with neuromyelitis optica spectrum disorder • Pooled data from two pivotal Phase III open-label extension (OLE) studies show satralizumab was well-tolerated as a monotherapy or in combination with baseline immunosuppressive therapy in people with neuromyelitis optica spectrum disorder (NMOSD) • Adolescents treated with the same dosing and frequency demonstrated a benefit-risk […]