April 26 (Reuters) - The U.S. Food and Drug Administration approved Pfizer's (PFE.N), opens new tab gene therapy for hemophilia B on Friday, the second such therapy for the rare bleeding disorder that typically requires regular infusions of a blood-clotting protein.
KING OF PRUSSIA, Pa., Feb. 11, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced top-line results from the Phase 3 AEGIS-II trial evaluating the efficacy and safety of CSL112 (apolipoprotein A-I [human]) compared to placebo in reducing the risk of major adverse cardiovascular events (MACE) in patients following an acute myocardial infarction (AMI). The study did not meet its primary efficacy endpoint of MACE reduction at 90 days. As a result, there are no plans for a near-term regulatory filing. There were no major safety or tolerability concerns with CSL112.
New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate
CSL and Arcturus Therapeutics’ ARCT-154 Demonstrates
KING OF PRUSSIA, Penn., Dec. 14, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for garadacimab (CSL312) as a once-monthly prophylactic treatment for hereditary angioedema (HAE). The company also announced the European Medicines Agency (EMA) has accepted the submission for CSL's Marketing Authorization Application (MAA) for garadacimab. If approved, garadacimab would become the first treatment for HAE in the U.S. and EU to target activated Factor XII (FXIIa).
KING OF PRUSSIA, Pa. and LEXINGTON, Mass., Oct. 27, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL) and uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the companies have received the 2023 Prix Galien USA Award in the category of Best Product for Rare/Orphan Diseases for HEMGENIX® (etranacogene dezaparvovec-drlb).
Oct 12 (Reuters) - Shares of biotechnology firm CSL (CSL.AX) fell to a four-year low on Thursday, after rival Novo Nordisk's (NOVOb.CO) Ozempic drug showed early signs of success in delaying the progression of kidney disease in diabetes patients.
SUMMIT, N.J., Aug. 28, 2023 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), was selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to deliver one bulk lot of H5N8 A/Astrakhan antigen to the U.S. government. This acquisition of a bulk lot will increase BARDA's stockpile of vaccine to support rapid response in an associated influenza pandemic.
With plasma collection as its stock-in-trade, the struggles of CSL during the coronavirus lockdown were understandable. But a rebound—fueled by a surge in post-pandemic collections and an $11.7 billion acquisition of Swiss blood specialist Vifor—has rekindled the growth of Australia’s largest biotech.
Aug 15 (Reuters) - Australian biotech giant CSL (CSL.AX) on Tuesday forecast increased earnings in fiscal 2024 for all its segments on strong demand and cost cutting, after posting a consensus-beating 2023 profit fuelled by record plasma collections.