Ophthalmology company Polyactiva Pty Ltd closed a AU$40 million (US$25 million) series C round to advance late-stage clinical trials in the U.S. of its lead candidate, PA-5108.
Xlear Inc., of Salt Lake City filed a petition in U.S. district court that could terminate the Federal Trade Commission’s practice of demanding substantiation of health care claims.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accord, Astrazeneca, Capricor, GSK, Lundbeck, Novo Nordisk, OS Therapies, Quoin, Zambon.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amarin, Bend, Kineta, Recordati, Sarepta, Starton, Thermo Fisher, Tuhura, Xcell.
The U.S. FDA said June 25 it has required updates to the prescribing labels of COVID-19 mRNA vaccines Comirnaty and Spikevax to include new safety information on the risks of myocarditis and pericarditis.
Australia’s largest health insurance company, Medibank Private Ltd., is the first to reimburse for psychedelic treatment in Australia, funding Emyria Ltd.’s MDMA (3,4-methylenedioxy-methamphetamine) program for post-traumatic stress disorder (PTSD) offered through the Perth Clinic.