Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bavarian, Duality, Replimune.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Biogen, Chengdu Kanghua, Hoth, Novo Nordisk.
Five years after the COVID-19 pandemic virtually locked down the U.S. government and society in general, the Patent Trial and Appeal Board (PTAB) is shedding the last vestiges of those days.
It’s not surprising that, of all the recommendations the U.S. CDC’s vaccine advisory board made at its June meeting, the first one Health and Human Services Secretary Robert Kennedy signed off on would essentially remove thimerosal from influenza vaccines in the U.S. What is surprising is the time it took for him to do so, given his long-held position on the preservative used in multidose vials and his insistence that a thimerosal presentation and vote be added to the agenda.
Amplia Therapeutics Ltd. is raising AU$27.5 million (US$18.12 million) to advance lead compound narmafotinib (AMP-945), a focal adhesion kinase (FAK) inhibitor, into new indications beyond pancreatic cancer.
Apnimed Inc.’s lead oral therapy for obstructive sleep apnea has delivered a second round of positive phase III data, bringing a potential U.S. FDA filing closer. Top-line results taken from the second pivotal late-stage study show AD-109 (aroxybutynin 2.5mg/atomoxetine 75 mg) hit its primary endpoint with clinically meaningful and statistically significant drops in airway obstruction at 26 weeks.
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