Roche announces collaboration with Atea Pharmaceuticals to develop a potential oral treatment for COVID-19 patients

Roche and Atea partner to jointly develop AT-527, an orally administered direct-acting antiviral (DAA) currently in Phase 2 clinical trials AT-527 has the potential to be the first novel oral antiviral to treat COVID-19 patients outside the hospital setting as well as in the hospital and may also be used in post-exposure prophylactic settings Oral,... Read more

Roche announces full FDA approval for Venclexta combinations for acute myeloid leukaemia

Approval supported by data from phase III confirmatory trials, VIALE-A and VIALE-C VIALE-A study showed Venclexta plus azacitidine significantly improved overall survival in newly diagnosed AML compared to azacitidine alone Supplemental New Drug Applications approved under the FDA’s Real-Time Oncology Review pilot programme and Project Orbis initiative              Basel, 19 October 2020 – Roche (SIX: RO,... Read more

Axxam and FUJIFILM Cellular Dynamics Announce Strategic Alliance to Deliver Integrated hiPSC Drug Discovery Solutions

MILAN (Italy) and MADISON (Wis., USA) –  October 6, 2020 – Axxam S.p.A., a leading provider of integrated drug discovery services across life sciences industries, and  FUJIFILM Cellular Dynamics, Inc., a leading developer and manufacturer of human induced pluripotent stem cell (hiPSC) models and therapies, announce a strategic alliance to improve the drug discovery process.... Read more

PerkinElmer Signals Notebook and PerkinElmer Signals Medical Review Cloud-Based Software Gain SOC 2 Attestation for Biopharmaceutical Research and Clinical Trial Data

Company’s Informatics Solutions Meet AICPA’s Trust Service Principles for Security, Confidentiality & Availability WALTHAM, Mass. –  September 30, 2020  –  PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced that the PerkinElmer Signals™ Notebook and PerkinElmer Signals™ Medical Review SaaS solutions have been granted SOC 2 Level 1 Attestation for... Read more

Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020

Data from the Phase III IMpassion031 study demonstrated that Tecentriq in combination with chemotherapy improved pathological complete response for patients with early triple-negative breast cancer (TNBC), when compared to placebo plus chemotherapy Final overall survival data from the Phase III IMpassion130 study were consistent with prior interim analyses in patients with metastatic TNBC, whose tumours... Read more

Roche’s phase III EMPACTA study showed Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with COVID-19 associated pneumonia

EMPACTA is the first global phase III trial to show efficacy with Actemra/RoActemra in COVID-19 associated pneumonia and the first with a focus on enrolling largely underserved and minority patients There was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo Roche plans to share these results with health authorities, including the... Read more

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

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

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

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