October 22, 2021 Acad, Gov/Utilities Bio/Pharma/CRO Clinical Research/Diagn. PR/Corporate

Roche’s VENTANA PD-L1 (SP263) Assay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq® (atezolizumab)

Lung cancer remains the leading cause of cancer-related deaths worldwide, with more than 2.2 million people diagnosed globally last year.1 The VENTANA PD-L1 (SP263) Assay helps determine which non-small cell lung cancer patients may benefit from treatment with Tecentriq immunotherapy based on the results of the Phase III IMpower010 study. This new test expands Roche’s... Read more

October 15, 2021 Acad, Gov/Utilities

US FDA approves Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer

Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting Approval is based on the Phase III IMpower010 study showing adjuvant Tecentriq improved disease-free survival by more than one-third in PD-L1-positive Stage II-IIIA lung cancer, compared with best supportive care Basel, 15 October 2021 – Roche (SIX: RO, ROG; OTCQX:... Read more

October 15, 2021 M&A, Partnerships

Roche announces PathAI collaboration for artificial intelligence-based digital pathology applications for improved patient care

Artificial Intelligence technology shows promise in advancing pathology imaging, which can benefit cancer patients through more precise diagnosis leading to targeted treatment. Collaboration with PathAI expands pathologist access to innovative AI-powered technology to support companion diagnostic and drug development programs. Builds on Roche’s Digital Pathology Open Environment, expanding the company’s commitment to improving patient outcomes... Read more

October 14, 2021 PAI Top-10 Product Launch

New four-year data show Roche's ENSPRYNG significantly reduces debilitating relapses in people with neuromyelitis optica spectrum disorder

New data demonstrate ENSPRYNG’s robust and sustained longer-term efficacy in preventing relapses in people with neuromyelitis optica spectrum disorder (NMOSD) More than 70% of people treated with ENSPRYNG remained relapse-free after four years in the SAkuraStar (73%) and SAkuraSky (71%) open-label extension (OLE) studies, with a favourable safety profile ENSPRYNG is now approved in 58... Read more

October 14, 2021 PAI Top-10

Roche’s Gazyvaro shorter 90-minute infusion time approved in Europe for people with previously treated or untreated follicular lymphoma

Basel, 14 October 2021 Short duration infusion of Gazyvaro® (obinutuzumab) is administered with a target infusion time of 90 minutes, compared to the current standard infusion time of approximately three to four hours Results from the phase IV GAZELLE study showed no new safety signals with the shorter infusion of Gazyvaro Shorter infusions could be... Read more

October 13, 2021 Licensing, IP, and Legal

Data up to 8-years for Roche’s OCREVUS (ocrelizumab) show early and ongoing treatment significantly reduced risk of requiring a walking aid in relapsing multiple sclerosis and disability progression in primary progressive multiple sclerosis

35% reduction in risk of needing a walking aid in relapsing multiple sclerosis (RMS) after 7.5 years vs. initiation 2 years later in Phase III open-label extension (OLE) 29% reduction in 48-week confirmed disability progression in primary progressive MS (PPMS) after 8 years vs. initiation after double-blind period in Phase III OLE New 8-year safety... Read more

October 8, 2021 Acad, Gov/Utilities

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

Gantenerumab is an investigational antibody in Phase III development for early Alzheimer’s disease (AD) Gantenerumab is the first and only anti-amyloid antibody being investigated for subcutaneous administration in late-stage trials for the treatment of AD Ongoing Phase III GRADUATE programme with gantenerumab is anticipated to deliver a comprehensive data set with expected readout in the... Read more

October 5, 2021 Licensing, IP, and Legal Product Launch

Roche to present new data on OCREVUS in multiple sclerosis and ENSPRYNG in neuromyelitis optica spectrum disorder at ECTRIMS 2021

OCREVUS (ocrelizumab) data to show sustained reduction in disability progression through 8 years for primary progressive multiple sclerosis (PPMS) and 7.5 years for relapsing MS (RMS) Long-term safety analysis of all clinical trials will reinforce the consistently favourable benefit-risk profile of OCREVUS ENSPRYNG (satralizumab) data to show efficacy and safety sustained over four years of... Read more

September 30, 2021 Bio/Pharma/CRO Clinical Research/Diagn.

Phase II/III trial shows Ronapreve™ (casirivimab and imdevimab) significantly reduces viral load within seven days of treatment in patients hospitalised with COVID-19

Trial met primary endpoint, showing Ronapreve significantly reduced viral load in seronegative patients hospitalised with COVID-19 who did not require high-flow oxygen or mechanical ventilation at baseline Clinical data complement previous findings in hospitalised setting, including from United Kingdom (UK) University of Oxford-led RECOVERY trial Basel, 30 September 2021 – Roche (SIX: RO, ROG; OTCQX:... Read more