December 21, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

Roche’s faricimab meets primary endpoint and shows strong durability across two global phase III studies for diabetic macular edema, a leading cause of blindness

Faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks in both studies More than half of participants in the faricimab personalised dosing arms had extended time between treatments to 16 weeks at year one – the first... Read more

December 14, 2020 Acad, Gov/Utilities Licensing, IP, and Legal

FDA approves Roche’s OCREVUS® (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis

Basel, 14 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for OCREVUS® (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). The... Read more

December 14, 2020 Acad, Gov/Utilities

GE Healthcare and St. Luke’s University Health Network Accelerate Breast Cancer Care with First One-Stop Clinic in the U.S.

St. Luke’s University Health Network in Pennsylvania to serve as national model for rapid diagnostic breast cancer centers One-stop breast clinics worldwide have revolutionized patient outcomes, with same-day results for 75 percent of patients and 80 percent patient satisfaction at the flagship clinic[1] CHICAGO, IL, December 14, 2020 – GE Healthcare (NYSE: GE) today announced... Read more

December 10, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

GE Healthcare Completes Portfolio of Macrocyclic MRI Contrast Agent Clariscan™ (gadoterate meglumine) with U.S. FDA Approval of Clariscan in 5mL Glass Vials

The U.S. FDA has approved 5mL glass vial packaging for Clariscan (gadoterate meglumine), completing its packaging portfolio. Clariscan is now approved for patients aged two years and under, making the 5mL vials an efficient option for helping to minimize potential contrast wastage with pediatric patients. Clariscan has been approved in more than 70 countries globally,... Read more

December 2, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

Roche announces FDA approval of Gavreto (pralsetinib) for people with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancers

Basel, 2 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto™ (pralsetinib) for the treatment of adult and paediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) who require systemic therapy,... Read more

December 2, 2020 Acad, Gov/Utilities PR/Corporate Product Launch

Roche receives FDA Emergency Use Authorization for new test to measure the level of SARS-CoV-2 antibodies

Basel, 2 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys® Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the... Read more

December 1, 2020 Acad, Gov/Utilities

FDA approves Xolair® (omalizumab) for adults with nasal polyps

Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation Xolair is now FDA-approved across three diseases and in two formulations, continuing to build on the medicine’s 17 years of patient experience since its initial approval for allergic asthma              Basel, 01 December... Read more

November 24, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

GE Healthcare Announces U.S. FDA approval of macrocyclic MRI Contrast Agent Clariscan™ (gadoterate meglumine) in Pre-Filled Syringes

U.S. FDA approves pre-filled syringe packaging for the macrocyclic gadolinium-based contrast agent, Clariscan™ (gadoterate meglumine). Clariscan has been approved in more than 70 countries globally, with more than seven million patient doses shipped, and now offers a wider range of packaging http://www.ge.com/news/press-releases/ge-healthcare-announces-us-fda-approval-of-macrocyclic-mri-contrast-agent Read more

November 24, 2020 Acad, Gov/Utilities Atomic Spectroscopy Microscopy

Microscopy at the MRC-University of Glasgow Centre for Virus Research

Meet four scientists using different types of light microscopy for virology research The MRC-University of Glasgow Centre for Virus Research (CVR) was established in 2010 and represents the UK’s largest grouping of human and veterinary virologists. The CVR is embedded within the Institute of Infection, Immunity and Inflammation at the University of Glasgow, which provides... Read more