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Good morning. Today, we talk about the big regulatory changes afoot in Europe, how telehealth upended the drug market, and more.
The need-to-know this morning
- Stoke Therapeutics appointed Ian Smith as its permanent CEO. He had been interim CEO since March.
- Invivyd reached an agreement with the FDA to conduct two clinical trials of its antibody treatment for the prevention of Covid-19 infection to support a potential approval. The studies will start before the end of the year and will report top-line results in the middle of 2026.
- AstraZeneca and Daiichi Sankyo said their antibody-drug conjugate Datroway prolonged survival in patients with advanced triple-negative breast cancer for whom immunotherapy was not an option.
- Abivax presented additional results from a study of its experimental drug, called obefazimod, for ulcerative colitis.
Europe nears sweeping pharma policy overhaul
European officials are racing to finalize a landmark overhaul of the E.U.’s pharmaceutical policies — the biggest in decades. It’s aimed at improving access to medicines, while keeping the continent attractive to drugmakers, STAT’s Andrew Joseph writes.
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