AGP Executive Report
Last update: 9 hours agoRegulatory Update (Pharma): Pharming says the U.S. FDA has accepted its resubmitted supplemental application for Joenja® (leniolisib) to treat children aged 4–11 with activated PI3Kδ syndrome (APDS), with a PDUFA target action date of 24 Oct 2026. Public Health (Ebola): The EMA is coordinating with the African Medicines Agency and African regulators on clinical trial designs and medical countermeasures for the ongoing Ebola outbreak in the DRC and Uganda, where no Bundibugyo-virus vaccines or treatments are currently authorised. Healthcare & Safety (Infectious Disease): Two NIH-linked researchers in the U.S. have been charged over an alleged attempt to smuggle mpox vials into the country from Congo, raising fresh concerns about biosafety and cross-border controls. Tech & Security (Healthcare-relevant AI): Anthropic expanded its Project Glasswing cybersecurity program to about 150 organisations, including healthcare-sector participants in the Netherlands, giving access to Claude Mythos Preview for vulnerability scanning. Local Health (Dermatology): A Dutch study reports that nearly 90% of dermatologists link TikTok skincare trends to patient skin problems.
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