Moderna Inc. blamed a switcheroo by the U.S. FDA for the refusal-to-file (RTF) letter on the seasonal influenza vaccine mRNA-1010. Shares of the firm (NASDAQ:MRNA) closed Feb. 11 at $40.51, down $1.49, having traded as low as $36.66 as investors learned of the RTF letter, which Moderna said is “inconsistent with feedback” the company was given by regulators during pre-phase III as well as pre-BLA-submission talks.
Henipaviruses like Nipah (NiV) and Hendra (HeV) are highly lethal, bat-borne zoonotic viruses from the Paramyxoviridae family that cause severe encephalitis and respiratory illness in humans and animals. These viruses are highly transmissible and have notable pandemic potential. Researchers are actively screening and testing numerous small-molecule compounds as potential treatments for henipavirus infections. A team at the University of Illinois Chicago and collaborators used a high-throughput screening approach to identify a focused library of analogues.
Scientists at Ghent University have created a mouse model that incorporates human versions of the receptors that recognize the fragment crystallizable region of immunoglobulin G, one of the most abundant antibodies in the blood and a key mediator of essential immune functions such as cellular activation, pathogen elimination and the regulation of inflammatory responses.
A recent publication in Cell Reports Medicine from researchers at the Washington University School of Medicine and the La Jolla Institute for Immunology presents a promising new strategy for H5N1 vaccination.
Looking to fill a treatment gap, the U.S. Biomedical Advanced Research and Development Authority (BARDA) is launching the first stage of a $100 million prize competition to support development of broad-spectrum, small-molecule antiviral therapies targeting viruses in the Togaviridae and Flaviviridae families.
Looking to fill a treatment gap, the U.S. Biomedical Advanced Research and Development Authority (BARDA) is launching the first stage of a $100 million prize competition to support development of broad-spectrum, small-molecule antiviral therapies targeting viruses in the Togaviridae and Flaviviridae families.
Scientists at Ghent University have created a mouse model that incorporates human versions of the receptors that recognize the fragment crystallizable (Fc) region of immunoglobulin G (IgG), one of the most abundant antibodies in the blood and a key mediator of essential immune functions such as cellular activation, pathogen elimination and the regulation of inflammatory responses. These human Fcγ receptors allow the humanized mouse to more accurately reproduce IgG-driven biology, enabling more reliable and safer preclinical assays before evaluating monoclonal antibodies in clinical trials with people.
Lixa Pty Ltd. has formed a partnership with the Global Antibiotic Research & Development Partnership and announced a AU$28 million (US$20 million) series B round to take Neox-121 to the clinic to fight antimicrobial resistance.
Certain chemical compounds can disable the bacterial immune systems that protect them from viruses, making the bacteria vulnerable to infection. Scientists at Indiana University have discovered a promising compound that works in different types of bacteria and could be used to develop potent and diverse phage therapies against bacterial infections, ultimately giving clinicians more options against antibiotic resistance.