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 seeks input into 'opaque' priority voucher scheme FDA seeks public input on controversial priority voucher scheme amid concerns about its transparency and legality. News FDA publishes advice on animal testing alternatives New draft guidance from the FDA is urging pharma companies to accelerate efforts to transition from animal testing to non-animal alternatives. News US court says pharma giants must face False Claims suit An appeals court in the US has said AbbVie, AstraZeneca, Novartis, and Sanofi must defend claims they defrauded federal and state governments. News US judge rules Kennedy's vaccine changes 'unlawful' A US judge has stymied attempts by HHS Secretary Kennedy to change immunisation policy, stopping this week's vaccine advisory panel from going ahead. more EU Policy updates 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 EMA and FDA agree 'principles' for AI in drug development The FDA and EMA have come up with guiding principles that they say will underpin future guidance on the use of AI technologies in drug development. more UK Policy updates News First MHRA/NICE aligned guidance due in June The aligned regulatory pathway for UK drugs regulator MHRA and reimbursement authority NICE gets underway on 1st April. News UK puts £50m behind expanded clinical trials drive The UK has awarded nearly £50m in funding for equipment to help the NHS carry out commercial clinical trials, with a focus on primary care capacity. News NHS "isn't delivering equitable care for rare diseases" A Genetic Alliance UK report claims the NHS is failing to meet the needs of many of the 3.5 million people in the country who live with rare diseases. News Joy as NICE changes tack on first NHS vitiligo treatment NHS patients in England with vitiligo will soon be able to access Incyte's Opzelura, the first drug shown to reverse the skin-lightening disorder. more
News FDA seeks input into 'opaque' priority voucher scheme FDA seeks public input on controversial priority voucher scheme amid concerns about its transparency and legality.
News FDA publishes advice on animal testing alternatives New draft guidance from the FDA is urging pharma companies to accelerate efforts to transition from animal testing to non-animal alternatives.
News US court says pharma giants must face False Claims suit An appeals court in the US has said AbbVie, AstraZeneca, Novartis, and Sanofi must defend claims they defrauded federal and state governments.
News US judge rules Kennedy's vaccine changes 'unlawful' A US judge has stymied attempts by HHS Secretary Kennedy to change immunisation policy, stopping this week's vaccine advisory panel from going ahead.
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 EMA and FDA agree 'principles' for AI in drug development The FDA and EMA have come up with guiding principles that they say will underpin future guidance on the use of AI technologies in drug development.
News First MHRA/NICE aligned guidance due in June The aligned regulatory pathway for UK drugs regulator MHRA and reimbursement authority NICE gets underway on 1st April.
News UK puts £50m behind expanded clinical trials drive The UK has awarded nearly £50m in funding for equipment to help the NHS carry out commercial clinical trials, with a focus on primary care capacity.
News NHS "isn't delivering equitable care for rare diseases" A Genetic Alliance UK report claims the NHS is failing to meet the needs of many of the 3.5 million people in the country who live with rare diseases.
News Joy as NICE changes tack on first NHS vitiligo treatment NHS patients in England with vitiligo will soon be able to access Incyte's Opzelura, the first drug shown to reverse the skin-lightening disorder.
