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.
Following a priority review, Scynexis Inc.'s oral antifungal, Brexafemme (ibrexafungerp), has won FDA approval for the treatment of vaginal yeast infections, also known as vulvovaginal candidiasis. The one-day oral treatment, which kills a broad range of Candida species, including azole-resistant strains, represents the first approved drug in a new antifungal class in more than 20 years as well as being Scynexis’ first commercial product.
LONDON – Pulmocide Ltd. has closed a $92 million oversubscribed series C, providing the means to take its inhaled antifungal drug, PC-945, through a global phase III registration study in invasive pulmonary aspergillosis.
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.
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.”
Parasitic worms, or helminths, are a major global health issue. At the same time, "parasites have been a prolific area of biomedical research to emerge," De'Broski Herbert told his audience at the 2021 annual meeting of the American Association of Immunologists.
Novavax Inc. backed off its guidance of submitting an EUA for its COVID-19 vaccine in June, pushing the anticipated date to this fall. “We expect to complete regulatory filings in the third quarter,” Stan Erck, Novavax’s president and CEO, told investors on a May 10 conference call. “We hope to have market authorizations in multiple countries in the third quarter, as early in the quarter as possible.”
Vaccitech plc and Werewolf Therapeutics Inc. opened the last day of April with contrasting IPOs. Both priced mid-range, with Vaccitech raising $110.5 million, similar to Werewolf's $120 million haul. However, American depository shares of Vaccitech (NASDAQ:VACC), co-developer of Astrazeneca plc’s COVID-19 vaccine, fell 17.1% to $14.10 from a $17 open, while shares of cancer therapy developer Werewolf (NASDAQ:HOWL) boomed – until they didn't – climbing to $24 before closing about where they started, at $16.10.
Respiratory syncytial virus, which puts millions of otherwise healthy infants in the hospital each year, could soon face a new foe. Top-line results from a phase III test of the extended half-life monoclonal antibody nirsevimab, developed by Astrazeneca plc and Sanofi SA, found it reduced lower respiratory tract infections requiring medical attention due to the virus in both healthy preterm and term infants.
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. The collaboration has already discovered promising compounds with antimalarial activity from among 80,000 drug-like molecules in the Janssen Jumpstarter Compound Library, a collection of drug-like compounds designed to fast-track discovery of new medicines.
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