Agilent Launches New NanoDis System for Nanoparticle Dissolution Testing

System addresses the pharmaceutical industry’s need for compliant, semi-automated testing of nanoparticle drug formulations SANTA CLARA, Calif., November 23, 2020  Agilent Technologies Inc. (NYSE: A) today announced the introduction of the NanoDis System for nanoparticle dissolution testing. Combining Agilent instrumentation and software to enable customers to meet 21 CFR Part 11 and other regulations through its... Read more

Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows Thermo Fisher and the Biopharmaceutical Analysis Training Laboratory (BATL) of Northeastern University aim to deliver cutting-edge analytical solutions and training programs SAN JOSE, Calif., Nov. 4, 2020 /PRNewswire/ — Thermo Fisher Scientific, the world leader in serving science, and the Biopharmaceutical... Read more

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