The EMA has changed its mind about an earlier decision that the risks of Leqembi (lecanemab) outweigh the benefits and is now recommending the Alzheimer’s disease drug is approved for a subgroup of patients. That follows an appeal by Eisai Co. Ltd. and a re-examination of the data, after details relating to 274 patients with two copies of the ApoE4 gene were removed from the file.
Arcturus Therapeutics Holdings Inc. has received IND clearance from the FDA to begin a phase I study of ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus.
Ifast Diagnostics Ltd. raised $6.5 million (£5 million) in seed funding to bring its rapid Antimicrobial Susceptibility Testing (AST) platform to the market. The company’s technology is vital in the fight against antimicrobial resistance and the funds will be used to conduct clinical trials to get the product to the market in the U.K., U.S. and EU, CEO Toby King, told BioWorld.
Westlake Pharmaceutical (Hangzhou) Co. Ltd. has prepared and tested new 3C-like proteinase (3CLpro; Mpro; nsp5) inhibitors reported to be useful for the treatment of coronavirus acute respiratory syndrome.
Modified vaccinia Ankara immunization in nonhuman primate models of lethal mpox virus infection, although effective to some extent, has been linked to breakthrough lesions and throat swab viremia.
Oregon Health and Science University (OHSU) and the Southern Research Institute have patented compounds reported to be useful for the treatment of alphaviral infections.
Phase III Scorpio-PEP study results showed Shionogi & Co. Ltd.’s oral antiviral ensitrelvir fumaric acid (Xocova) reduced risk of symptomatic COVID-19 infection in subjects who were exposed to the virus by infected household members.
Qiagen NV added to its growing roster of panels cleared by the U.S. FDA in 2024 with the agency’s nod for its Qiastat-Dx Meningitis/Encephalitis assay. The clearance validates Qiagen’s strategy of developing rapid tests specifically for the U.S. market and builds on the respiratory, gastrointestinal and central nervous system tests already available.
F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. have patented tricyclic compounds acting as UDP-2,3-diacylglucosamine hydrolase (LpxH) (bacterial) inhibitors and thus reported to be useful for the treatment of gram-negative bacterial infections.
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