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 ramps up its pushback against compounded GLP-1s In a move that will please Novo Nordisk and Eli Lilly, the FDA sent warnings to 30 telehealth firms, accusing them of illegally marketing GLP-1 drugs. News CMS extends deadline for MFN pricing pilot scheme CMS has extended the deadline for its Medicaid drug pricing pilot, GENEROUS, to "provide interested drug manufacturers more opportunity to join." News US lawmakers take FDA to task over rare diseases record Lawmakers and patient advocates in the US are concerned that the FDA's regulation of rare disease therapies has been inconsistent and overly cautious. News In brief SOTU remarks, Trump asks Congress to "codify" MFN In a speech at least nominally focused on the economy and affordability, President Trump put surprisingly little emphasis on his drug pricing efforts. 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 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. News UK seeks views on indefinite CE marks for medical devices The UK has launched a consultation asking whether medical devices with CE marks issued in the EU and sold in GB should be recognised indefinitely. more
News FDA ramps up its pushback against compounded GLP-1s In a move that will please Novo Nordisk and Eli Lilly, the FDA sent warnings to 30 telehealth firms, accusing them of illegally marketing GLP-1 drugs.
News CMS extends deadline for MFN pricing pilot scheme CMS has extended the deadline for its Medicaid drug pricing pilot, GENEROUS, to "provide interested drug manufacturers more opportunity to join."
News US lawmakers take FDA to task over rare diseases record Lawmakers and patient advocates in the US are concerned that the FDA's regulation of rare disease therapies has been inconsistent and overly cautious.
News In brief SOTU remarks, Trump asks Congress to "codify" MFN In a speech at least nominally focused on the economy and affordability, President Trump put surprisingly little emphasis on his drug pricing efforts.
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 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.
News UK seeks views on indefinite CE marks for medical devices The UK has launched a consultation asking whether medical devices with CE marks issued in the EU and sold in GB should be recognised indefinitely.
