September 15, 2020 Bio/Pharma/CRO Informatics & Software Lab Top-10 Product Launch

PerkinElmer Launches DA 7350™ Instrument and Cloud-Based Software for Quality Control in Food Production

Solution helps producers reduce waste, increase product consistency and productivity and lower costs WALTHAM, Mass. – Sept 15, 2020 – PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today introduced the DA 7350™ instrument and Process Plus™ cloud-based software to provide continuous quality control for food and food ingredient manufacturing processes.... 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 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 10, 2020 Bio/Pharma/CRO Chromatography

Roche provides update on phase III studies of etrolizumab in people with moderately to severely active ulcerative colitis

Etrolizumab met its primary endpoint of inducing remission versus placebo for people with ulcerative colitis in only two of three studies Etrolizumab failed to meet its primary endpoint versus placebo as maintenance therapy in people with ulcerative colitis Analyses of these data are ongoing to better understand the results Pivotal phase III study of etrolizumab... Read more

August 6, 2020 Bio/Pharma/CRO Licensing, IP, and Legal

Roche provides update on Phase III study of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer

Basel, 06 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpassion131 study, evaluating Tecentriq® (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-free survival (PFS) for the initial (first-line) treatment of people with metastatic... Read more

July 29, 2020 Bio/Pharma/CRO Clinical Research/Diagn. Microscopy

Roche provides an update on the phase III COVACTA trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 associated pneumonia

COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality The study is the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in... Read more

July 28, 2020 Bio/Pharma/CRO Lab Top-10 Licensing, IP, and Legal M&A, Partnerships

Thermo Fisher Scientific and Lyell Immunopharma Form Cell Therapy Manufacturing Partnership

Thermo Fisher Scientific and Lyell Immunopharma Form Cell Therapy Manufacturing Partnership Collaboration will include development of Thermo Fisher products and strategic manufacturing support WALTHAM, Mass., July 28, 2020 /PRNewswire/ — Thermo Fisher Scientific Inc., the world leader in serving science, and biotechnology company Lyell Immunopharma, are partnering to develop manufacturing processes designed to create more... Read more