BEIJING – China will kickstart a phase III trial Feb. 3 to determine whether patients with 2019-nCoV can be treated with Gilead Sciences Inc.’s NUC inhibitor, remdesivir, which was originally developed for Ebola, four days after a U.S. patient was said to have recovered by using the drug candidate.
Salt Lake City-based Co-Diagnostics Inc. has finished the principle design work for a polymerase chain reaction (PCR) screening test for the novel coronavirus that has sickened nearly 3,000 with an acute respiratory illness and killed more than 80 people in Wuhan, China.
BEIJING – With promising phase II data in hand – and newly designated FDA orphan drug status – Suzhou, China-based Tennor Therapeutics Suzhou Co. Ltd. is gearing up to move into pivotal testing with TNP-2092 to treat prosthetic joint infections.
LONDON – After a second day of deliberation, the World Health Organization (WHO) held off declaring that the novel coronavirus infection raging in Wuhan is an international health emergency, saying the low number of cases outside China means it is not time to escalate the response to this level.
HONG KONG - South Korean biopharmaceutical company Quratis Inc. and Indonesia’s state-run company, Bio Farma PT, have entered a term sheet agreement to develop and commercialize Quratis’ tuberculosis (TB) vaccine, QTP-101, for adults and adolescents.
HYDERABAD – India, home to a quarter of the global tuberculosis (TB) cases, plans to enhance its capacity to fight TB drug resistance and bolster susceptibility testing under a new initiative launched by the Geneva-based nonprofit Foundation for Innovative New Diagnostics (FIND).
Briefing documents released ahead of Wednesday’s meeting of the FDA’s Antimicrobial Drugs Advisory Committee, slated to review Shionogi & Co. Ltd.’s cefiderocol for treatment of complicated urinary tract infections (cUTIs), spotlighted a finding of increased mortality among critically ill cefiderocol-treated patients in the company’s Credible-CR study.
HONG KONG – Kobiolabs Inc., a microbiome-based venture from Seoul, South Korea, has secured a KRW26.6 billion (US$22.2 million) investment. Founded in 2014, the venture has achieved KRW193 billion of enterprise value.
HONG KONG – Taiwan's National Health Insurance Administration has added Gilead Sciences Inc.'s Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide), a once-daily single tablet for the treatment of adults with HIV-1, to its list of reimbursed medicines.
WASHINGTON – Hot on the heels of July's FDA approval of Recarbrio (imipenem, cilastatin and relebactam) in complicated urinary tract infections (cUTIs), Merck & Co. Inc. rolled out pivotal phase III data at the Infectious Disease Society of America's IDWeek 2019 that could support expanding its label to another high-need group, people with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP).
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