Welcome to the dedicated Spotlight On Policy page, your central resource for curated, expert-driven coverage of pharmaceutical and health system policy across the United States, the United Kingdom, Europe, and the wider global landscape. US Policy updates News Is Makary on the way out, and who might replace him? Marty Makary's position as FDA Commissioner is said to be in jeopardy, raising the threat of further chaos at the agency if he is ousted. News Danco fights back after US court curbs abortion pill access In another setback for abortion care in the US, an appeals court has issued an order restricting the distribution of mifepristone through the mail. News Amgen, AZ will pilot FDA's real-time clinical trial plan The FDA has published a plan to allow data from clinical trials to be reported to the agency as they occur in real time. News FDA clears first genetic hearing loss gene therapy Regeneron's Otarmeni is the first gene therapy for congenital hearing loss to be cleared by the FDA, and will be made available for free in the US. more EU Policy updates News EU agrees plan to tackle essential medicine shortages Lawmakers in the EU have reached a provisional agreement to strengthen the bloc's critical medicine supply chain and avert the risk of shortages. Market Access European biopharma at a crossroads If Europe can bridge its operational gaps while leveraging its scientific base, it can carve out a distinctive and sustainable leadership position. Market Access US pharma MFN and tariff dynamics: What EU and UK leaders ne... Europe and the United Kingdom are entering a period of direct exposure to US policy choices, and the implications are significant and immediate. News Novartis issues a life sciences warning in a 'G-Zero' world Novartis claims life sciences lie at the centre of a shift in geopolitics and policies in regions like Europe, Japan, and Canada are "self-defeating." more UK Policy updates News Clock starts ticking on UK's single patient record plan In today's King's Speech, the UK government unveiled the NHS Modernisation Bill, starting the process of introducing a single patient record. News Neurology, biomanufacturing start-ups bag UK AI funding The first recipients of the UK government's £500 million Sovereign AI fund have been announced, including two life sciences-focused start-ups. News UK says it has hit target on commercial trial set-up times The UK has made progress in its efforts to slash set-up times for clinical trials, one of the factors blamed for a decline in industry-backed studies. News NHS risks missing out on independent prescriber benefits Gaps in support could undermine a wave of new independent prescribers entering the NHS and a push for more community-based care, warns a new report. more
News Is Makary on the way out, and who might replace him? Marty Makary's position as FDA Commissioner is said to be in jeopardy, raising the threat of further chaos at the agency if he is ousted.
News Danco fights back after US court curbs abortion pill access In another setback for abortion care in the US, an appeals court has issued an order restricting the distribution of mifepristone through the mail.
News Amgen, AZ will pilot FDA's real-time clinical trial plan The FDA has published a plan to allow data from clinical trials to be reported to the agency as they occur in real time.
News FDA clears first genetic hearing loss gene therapy Regeneron's Otarmeni is the first gene therapy for congenital hearing loss to be cleared by the FDA, and will be made available for free in the US.
News EU agrees plan to tackle essential medicine shortages Lawmakers in the EU have reached a provisional agreement to strengthen the bloc's critical medicine supply chain and avert the risk of shortages.
Market Access European biopharma at a crossroads If Europe can bridge its operational gaps while leveraging its scientific base, it can carve out a distinctive and sustainable leadership position.
Market Access US pharma MFN and tariff dynamics: What EU and UK leaders ne... Europe and the United Kingdom are entering a period of direct exposure to US policy choices, and the implications are significant and immediate.
News Novartis issues a life sciences warning in a 'G-Zero' world Novartis claims life sciences lie at the centre of a shift in geopolitics and policies in regions like Europe, Japan, and Canada are "self-defeating."
News Clock starts ticking on UK's single patient record plan In today's King's Speech, the UK government unveiled the NHS Modernisation Bill, starting the process of introducing a single patient record.
News Neurology, biomanufacturing start-ups bag UK AI funding The first recipients of the UK government's £500 million Sovereign AI fund have been announced, including two life sciences-focused start-ups.
News UK says it has hit target on commercial trial set-up times The UK has made progress in its efforts to slash set-up times for clinical trials, one of the factors blamed for a decline in industry-backed studies.
News NHS risks missing out on independent prescriber benefits Gaps in support could undermine a wave of new independent prescribers entering the NHS and a push for more community-based care, warns a new report.