Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection to treat Retinopathy of Prematurity (ROP) in preterm infants. The target action date for the FDA decision is February 11, 2023.
https://finance.yahoo.com/news/eylea-aflibercept-injection-sbla-treatment-110000734.html
Homologous boosting with the prototype Novavax COVID-19 vaccine induced robust antibody titers for Omicron BA.1, BA.2, and BA.5
Study 307 (Lot Consistency) achieved its primary endpoint, showing that three vaccine lots induced a comparable immune response thereby demonstrating the consistency of the manufacturing process
A durable immunogenicity response was observed following primary vaccination as well as boosting which matched the levels previously associated with protection
Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3, today announced that its Investigational New Drug (IND) application for belapectin in combination with a checkpoint inhibitor for the treatment of Head and Neck cancer has been filed with the U.S. Food and Drug Administration (FDA) Oncology division. Galectin Therapeutics also received a Study May Proceed letter for a Phase 2 clinical trial entitled “A Phase 2 Study of the Efficacy and Safety of Belapectin in Combination with Pembrolizumab (Keytruda®) as First-Line Treatment in subjects with Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck.”
https://finance.yahoo.com/news/galectin-therapeutics-receives-fda-approval-120000125.html
Company plans to commence an adequately powered Phase 2 study with approximately 276 patients with severe community-acquired pneumonia at 120 sites worldwide with patient enrollment expected as early as the beginning of 2023 --
-- Interim results expected approximately one year after patient enrollment begins --
-- CAL02 is being developed as an add-on to the clinically indicated antibiotic treatment and potentially offers unique therapeutic benefits to critically ill patients, including immediate decrease in inflammatory biomarkers, shorter duration of critical care management such as mechanical ventilation, and ultimately a reduced mortality risk --
Option exercised on undisclosed immune-oncology target following evaluation period by Moderna -
- Autolus receives option exercise fee, with potential for development milestone payments plus royalties -
https://finance.yahoo.com/news/moderna-exercises-option-license-proprietary-110000823.html
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on developing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide, today announced that BRUKINSA® (zanubrutinib) achieved superior Progression-Free Survival (PFS) versus IMBRUVICA® (ibrutinib) in a final analysis of the Phase 3 ALPINE trial, as assessed by an independent review committee (IRC) and investigator. BRUKINSA was generally well tolerated; safety findings at the final PFS analysis were consistent with prior reports.
https://finance.yahoo.com/news/beigene-announces-positive-topline-results-110000999.html
Moderna Inc said on Wednesday Merck & Co Inc had exercised an option to jointly develop and potentially sell an mRNA-based cancer vaccine.
The vaccine, mRNA-4157, is being tested along with Merck's blockbuster cancer immunotherapy Keytruda, in a mid-stage trial. Data on the vaccine is expected in the fourth quarter of this year.
Merck will pay $250 million to exercise the option, as agreed under a 2016 agreement, Moderna said
The vaccine is designed to generate T-cells, a key part of the body's immune response, based on the mutational signature of a patient's tumor.
https://finance.yahoo.com/news/1-merck-opts-jointly-develop-113551661.html
