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WHO lists Novavax’s updated Covid-19 vaccine NVX-CoV2601 for emergency use
The EUL for NVX-CoV2601 was granted based on non-clinical evidence which demonstrated that the vaccine produced functional immune responses against the XBB.1.5, XBB.1.16, and XBB.2.3 variants
Aro Biotherapeutics Secures $41.5M Series B Financing
Funds will support progression of Aro’s pipeline of Centyrin-siRNA programs, including ABX1100, a novel potential treatment for Pompe Disease
Sernova Receives Orphan Drug and Rare Pediatric Disease Designations for its Hemophilia A Program from FDA
Sernova announces research collaboration with Professor Antonia Follenzi, expert in hemophilia A at the University of Piemonte Orientale
Trillium Health Partners to become first in Canada to deploy AI in diagnostic imaging using Sectra Amplifier Services
International medical imaging IT and cybersecurity company Sectra (STO: SECT B) helps Trillium Health Partners (THP) in Canada adopt AI technology with new AI-as-a-service agreement via Sectra Amplifier Services. This will enable THP to introduce AI-powered workflows in its diagnostic imaging department, which will help identify serious health conditions sooner, allowing for earlier intervention and better health outcomes.
Mesoblast seeks FDA ODD, RPDD status for Revascor to treat congenital heart disease
The filings were based on the findings from a blinded, randomised, controlled prospective trial of Revascor in which a single dose significantly increased LV systolic and diastolic volumes
Novartis recalls two lots of Sandimmune oral solution in US over crystallisation issue
The Swiss pharmaceutical firm has recalled the Sandimmune Oral Solution after finding crystal formation in some bottles, which can result in incorrect dosing
DxVx to license OVM-200 anti-cancer vaccine candidate, hold trials in Asia
The therapeutic vaccine candidate is currently slated to enter into a Phase 1b trial following the completion of a Phase 1a clinical trial in the first half of this year
First-ever therapy for rare genetic disease in babies to save lives on the NHS
Sebelipase alfa is an enzyme replacement therapy, which works by replacing an enzyme missing in the body, alongside a restricted, low-fat diet
EC approves expanded label for Kaftrio combo in children with cystic fibrosis
The commission has approved Kaftrio in combination with ivacaftor to treat CF in patients aged two years and older who have at least one copy of the F508del mutation in the CFTR gene
Lupin Receives Tentative Approval from US FDA for Canagliflozin Tablets
Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor