Micurx Pharmaceuticals Inc. has won marketing approval from China's NMPA for its lead antibacterial, contezolid, for treating adults with complicated skin and soft tissue infection (cSSTI), marking the first NDA for the Shanghai drugmaker. Set to be marketed as Youxitai in China, Micurx discovered the new-generation oral oxazolidinone antibiotic, developing it over 12 years. It’s designed to treat multidrug-resistant gram-positive bacteria such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococci.
In their latest submission to Science, Weifeng Shi, director and professor at the Institute of Pathogen Biology at Shandong First Medical University in China, and George Gao, head of Chinese Center for Disease Control and Prevention, have warned that “the global spread of H5N8 avian influenza viruses is a public health concern.”
New three-year safety and efficacy data on Takeda Pharmaceutical Co. Ltd.'s dengue vaccine candidate, TAK-003, showed it to be 62% more effective than placebo in preventing virologically confirmed infections with the virus and 83.6% more effective than placebo in preventing hospitalizations caused by the mosquito-borne viral disease and due to any of the four dengue virus serotypes in patients ages 4 to 16.
A collaboration aimed at identifying and developing potential new antimalarial drug candidate drugs has been announced between Walter and Eliza Hall Institute for Medical Research in Melbourne, Australia, and Janssen Pharmaceutica, with assistance from Johnson & Johnson Innovation.
New phase IIb clinical trial data show the antigen R-21, a malaria vaccine candidate created by the University of Oxford that uses Novavax Inc.'s Matrix-M adjuvant, demonstrated 77% efficacy in children.
Four years after leaving the Nasdaq, Sciclone Pharmaceuticals Holdings Ltd. returned to the market March 3, issuing 116 million shares to raise HK$2.18 billion (US$281 million) on the Hong Kong Stock Exchange (HKEX). Shares were priced at HK$18.8 each.
HONG KONG – Lianbio Co. Ltd. has inked a deal for the development and commercialization of Reviral Ltd.’s sisunatovir, picking up rights to the respiratory syncytial virus (RSV) candidate in mainland China, Hong Kong, Macau and Singapore in exchange for an up-front cash payment of $14 million and development and commercial milestone payments of up to $105 million.
HONG KONG – Hansoh Pharmaceutical Group Co. Ltd. picked up the greater China rights to Scynexis Inc.’s lead candidate, ibrexafungerp. Hansoh will take charge of the development, regulatory approval and commercialization of the antifungal in exchange for a $10 million up-front payment and as much as $112 million in milestones.
HONG KONG – Ferring Pharmaceuticals’ microbiome-focused subsidiary Rebiotix Inc. and Mybiotics Pharma Ltd. have agreed to a multiyear strategic collaboration to develop live microbiota-based biotherapeutics to address bacterial vaginosis.
PERTH, Australia – Synthetic cannabinoid company Botanix Pharmaceuticals Ltd. announced top-line data from a phase IIa study showing that two different formulations of BTX-1801, a synthetic cannabidiol (CBD), eradicated Staphylococcus aureus (staph) in the nose, meeting study endpoints for safety and efficacy.