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 FDA prior knowledge guide seeks to speed cell, gene therapy The FDA has laid out a framework to use 'prior knowledge' on manufacturing, non-clinical, and clinical data to support cell and gene therapy filings. News SCOTUS won't hear pharma's IRA complaints The US Supreme Court has refused to consider lawsuits from pharma groups challenging Medicare's drug pricing negotiation powers. News After refusing to resign, CDER head Høeg is fired The turmoil at the FDA continues with the news that Tracy Beth Høeg has been fired as acting head of CDER, to be replaced by Michael Davis. News SCOTUS retains telemedicine access to abortion pill The Supreme Court of the US has ruled that abortion pill mifepristone can continue to be prescribed remotely and delivered by mail-order – for now. more EU Policy updates News European study shows inequality in access to new medicines Trade organisation EFPIA says disparities in access to new medicines in Europe may be exacerbated by the US's Most-Favoured Nation (MFN) policy. 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. more UK Policy updates News £600m funding call opens for UK biomedical research centres £600m in funding is being allocated for an expansion in the network of biomedical research centres, a pillar of the UK's life sciences strategy. News DHSC lauds benefits of single patient record ahead of debate The NHS digital single patient record (SPR) could result in 20,000 fewer A&E visits in England per year and save £20m a year, says the UK government. News Pharmacy First prescribing expanded to ease GP pressure From the autumn, pharmacists in England will be able to prescribe a wider array of medicines under the Pharmacy First programme. News Review advises against broad NHS prostate cancer screening The UK's National Screening Committee has concluded that the harms of widespread prostate cancer screening would outweigh its benefits. more
News FDA prior knowledge guide seeks to speed cell, gene therapy The FDA has laid out a framework to use 'prior knowledge' on manufacturing, non-clinical, and clinical data to support cell and gene therapy filings.
News SCOTUS won't hear pharma's IRA complaints The US Supreme Court has refused to consider lawsuits from pharma groups challenging Medicare's drug pricing negotiation powers.
News After refusing to resign, CDER head Høeg is fired The turmoil at the FDA continues with the news that Tracy Beth Høeg has been fired as acting head of CDER, to be replaced by Michael Davis.
News SCOTUS retains telemedicine access to abortion pill The Supreme Court of the US has ruled that abortion pill mifepristone can continue to be prescribed remotely and delivered by mail-order – for now.
News European study shows inequality in access to new medicines Trade organisation EFPIA says disparities in access to new medicines in Europe may be exacerbated by the US's Most-Favoured Nation (MFN) policy.
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 £600m funding call opens for UK biomedical research centres £600m in funding is being allocated for an expansion in the network of biomedical research centres, a pillar of the UK's life sciences strategy.
News DHSC lauds benefits of single patient record ahead of debate The NHS digital single patient record (SPR) could result in 20,000 fewer A&E visits in England per year and save £20m a year, says the UK government.
News Pharmacy First prescribing expanded to ease GP pressure From the autumn, pharmacists in England will be able to prescribe a wider array of medicines under the Pharmacy First programme.
News Review advises against broad NHS prostate cancer screening The UK's National Screening Committee has concluded that the harms of widespread prostate cancer screening would outweigh its benefits.
