Ascletis Pharma Inc. presented subgroup data from a phase II trial showing its subcutaneous PD-L1 antibody envafolimab (ASC-22) was able to functionally cure chronic hepatitis B, according to hepatitis B surface antigen decline following 24-week treatment.
Anthony Fauci has retired from his position as director of the National Institute of Allergy and Infectious Diseases (NIAID) and as chief medical advisor to the U.S. president. But Fauci, who has advised every president since Ronald Reagan, continues to share his encyclopedic knowledge with the HIV research community, as he has since the beginning of the HIV pandemic. Fauci co-founded the first National Conference on Human Retroviruses and related infections in 1993. At the Opening Session of the 30th edition of the Conference on Retroviruses and Opportunistic Infections (CROI), he highlighted the advances that have collectively extended the life expectancy of newly diagnosed patients by decades.
Zhimeng Biopharma Inc. found a global partner for its hepatitis B virus (HBV) program, licensing rights to GSK plc for CB-06, an oral small-molecule Toll-like receptor 8 agonist. Pending positive data from an ongoing phase I study, GSK will gain rights to develop, manufacture and commercialize the drug for chronic HBV infection, either for use in combination or as a sequential treatment with bepirovirsen.
Changchun Bcht Biotechnology Co. Ltd. has obtained marketing approval for its live attenuated zoster vaccine in China, making it the first approved shingles vaccine developed by a Chinese company. An injectable of 0.5 ml per dose, it is designed for adults ages 40 and older and will go up against GSK plc’s Shingrix vaccine.
Following Therapeutic Goods Administration approval of its first-generation donor-derived microbiome-based therapy, Biomictra, for recurrent Clostridioides difficile infection, Australia’s Biomebank is scaling up to meet increasing global demand for fecal microbiota products and is developing a more scalable second-generation synthetic product.
Raynovent Biotech Co. Ltd. has raised ¥370 million (US$54 million) in a series C round to further develop candidates in the field of respiratory and metabolic diseases.
Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, failed to meet the primary endpoint of noninferiority compared to Roche Holding AG’s valganciclovir in the phase III Aurora study for cytomegalovirus (CMV) infection in hematopoietic stem cell transplant recipients. The multicenter, randomized, double-blind, double-dummy, active-controlled study was to form the basis for a future label expansion for the therapy.
Pfizer Inc. has acquired rights to respiratory syncytial virus (RSV) drug candidate sisunatovir from Lianbio Co. Ltd. in a deal worth up to $155 million covering development and commercialization rights in mainland China, Hong Kong, Macau and Singapore. With this agreement, Pfizer now holds global development and commercialization rights to the candidate, an orally administered fusion inhibitor is designed to block RSV replication by inhibiting F-mediated fusion with the host cell.
CSL Ltd. subsidiary CSL Seqirus signed a licensing and development deal with Arcturus Therapeutics Inc. to in-license Arcturus’ late-stage self-amplifying mRNA vaccine platform technology. Arcturus will receive $200 million up front and is eligible to receive more than $1.3 billion in development milestones and over $3 billion in commercial milestones.
CSL Ltd. subsidiary Seqirus inked a $30.1 million deal with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop and evaluate two influenza A subtype H2Nx (avian flu) vaccines in a phase I trial.
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