Category: Acad, Gov/Utilities
PerkinElmer SARS-CoV-2 RT-PCR Assay Receives FDA EUA for Asymptomatic Testing
Gold-standard testing of individuals without COVID-19 symptoms key to controlling the spread WALTHAM, Mass. –(BUSINESS WIRE)–Jan. 14, 2021– PerkinElmer, Inc. (NYSE:PKI) announced today that its PerkinElmer ® New Coronavirus Nucleic Acid Detection Kit received Emergency Use Authorization (EUA) Read more
Roche confirms US government agreement to purchase additional doses of Regeneron’s casirivimab and imdevimab
Basel, 12 January 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of Regeneron’s casirivimab and imdevimab antibody cocktail for use in non-hospitalised COVID-19 patients as part of Operation Warp Speed. The US government... Read more
Roche’s novel anti-TIGIT tiragolumab granted FDA Breakthrough Therapy Designation in combination with Tecentriq for PD-L1-high non-small cell lung cancer
Basel, 5 January 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA), in combination with Tecentriq® (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung... Read more
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
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
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
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
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