South Korean biopharmaceutical company Celltrion Inc. submitted a BLA to the U.S. FDA on March 10 to gain approval for its Xolair (omalizumab; Novartis AG) biosimilar, CT-P39, across major indications of asthma, food allergy and chronic spontaneous urticaria.
South Korean biopharmaceutical company Celltrion Inc. submitted a BLA to the U.S. FDA on March 10 to gain approval for its Xolair (omalizumab; Novartis AG) biosimilar, CT-P39, across major indications of asthma, food allergy and chronic spontaneous urticaria.
Several presentations at the 31st Conference on Retroviruses and Opportunistic Infections (CROI 2024) held in Denver from March 3 to 6, 2024, focused on childhood HIV and highlighted the lack of pediatric data. The epicenter of this pandemic in the youngest is in the southern region of the African continent. However, there are few studies for children with HIV, mostly for the northern hemisphere.
Work at Bellbrook Labs LLC has led to the identification of cyclic GMP-AMP synthase (MB21D1; cGAS) inhibitors reported to be useful for the treatment of autoimmune diseases.
The research on novel vaccines against SARS-CoV-2 with improved characteristics continues. These ideal features include rapid development to target variants of concern, easy manufacturing, and an excellent safety profile while inducing humoral and cellular immune responses.
Creative Medical Technology Holdings Inc.'s Immcelz (CELZ-101) has been awarded orphan drug designation by the FDA. Immcelz is aimed at preventing allograft rejection in patients undergoing pancreatic islet cell transplantation.
Neuraminidase (NA) is an essential surface protein of influenza viruses with potential as an effective drug and vaccine target. However, knowledge of the NA antigenic landscape remains limited, and most current influenza vaccines induce antibodies against the surface glycoprotein hemagglutinin.
Imunon Inc. has released promising results from a live virus challenge study conducted by the Wistar Institute with IMNN-101 against the SARS-CoV-2 variant XBB.1.5. This study was conducted using the clinical vector that Imunon intends to bring into its phase I study during the second quarter, and showed IMNN-101 immunogenicity and protective activity in a live viral mouse challenge.
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is awarding Glyprovac LLC US$467,000 to develop a maternal vaccine that targets Escherichia coli, a bacterial species responsible for a large portion of neonatal sepsis infections.
Dyadic International Inc.'s Dutch subsidiary, Dyadic Nederland BV, has entered into a strategic partnership agreement and collaboration with Rabian BV to develop efficacious, scalable, and affordable rabies prophylactics and vaccines utilizing Dyadic's C1 protein production platform.
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