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.

CEO Mark McKenna told BioWorld Asia that San Diego-based Prometheus Biosciences Inc. has "cracked the code" in inflammatory bowel disease (IBD) – progress underscored by the firm's deal with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, which brings an undisclosed up-front payment and as much as $420 million more if development, regulatory and commercial milestones are reached in three programs.

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).

BEIJING – The ongoing trade war between the U.S. and China has helped put the biotechnology field on the U.S. foreign investment restriction list, causing a chilling effect on the market.

BEIJING – China's position as a global power in active pharmaceutical ingredients (API) could be jeopardized by the ongoing and worsening trade war with the U.S. Perhaps more worrisome for the pharma industry, any disruption to Chinese supply chains could have a serious impact on drug manufacturing and accessibility globally.

BEIJING – Despite tensions between the U.S. and China, especially in the tech sector, Oncologie Inc. maintains its plans to pursue drug development in both markets. The clinical-stage startup, led by U.S. scientists and funded with Chinese capital, has stationed itself in both Boston and Shanghai to focus on developing innovative cancer therapies simultaneously in China and the U.S.

Japan's Sumitomo Dainippon Pharma Co. Ltd. plans to pay $3 billion to acquire Roivant Sciences Ltd.'s ownership interests in five biopharma companies, plus options to acquire up to six more from the prolific company-builder. The deal, slated to close in October, would give Sumitomo Dainippon controlling interests in Myovant Sciences Inc., Urovant Sciences Inc., Enzyvant Therapeutics Inc. and Altavant Sciences Inc., as well as an equity stake of more than 10% in Roivant itself.

BEIJING – Multinational antibody specialist Hifibio Therapeutics Inc. said it closed a $67 million series C financing round to advance its drug candidates for cancer and autoimmune disorders.