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 could hike user fees for ex-US drug programmes FDA mulls reduced fees for programmes with US-based phase 1 trials, and higher fees for those tested overseas, to incentivise US R&D. News FDA takes steps to limit non-human primate testing New draft guidance from the FDA says single-target antibodies will no longer need six-month toxicity testing in animals like macaques. News FDA doubles down on its push into AI The FDA has revealed the latest element in its adoption of AI, an agentic AI platform that agency staffers can use to streamline complex tasks. News UK and US agree zero tariffs on pharma – with price rises A deal between the UK and the US will maintain tariffs on imports into the US at 0%, but prices of medicines used by the NHS will go up. more EU Policy updates Market Access How are the US MFN and German MFG likely to impact pharmaceu... A comparison of the US MFN and German MFG. News Bayer gets EU approval for menopause drug Lynkuet Bayer now has approval on both sides of the Atlantic for Lynkuet, with the EU backing it for symptoms caused by both menopause and breast cancer. News Approvals extend use of Roche, AbbVie drugs in lymphoma Patients in the US and EU with follicular lymphoma have new treatment options, thanks to new approvals for CD20xCD3 bispecifics Lunsumio and Epkinly. Market Access Beyond the Bill: how do we make medicines affordable without... Two pharmaceutical giants have paused investment in the UK. More than a setback for British life sciences, it’s a warning sign for the future. more UK Policy updates News Slow recruitment still hitting UK trials, says pharma Despite efforts to improve the environment for UK clinical trials, the sector is still facing headwinds like low recruitment rates and rising costs. News UK and US agree zero tariffs on pharma – with price rises A deal between the UK and the US will maintain tariffs on imports into the US at 0%, but prices of medicines used by the NHS will go up. News Real-world trial of Lilly's tirzepatide starts in UK A real-world study exploring the long-term effects of Eli Lilly's weight-loss therapy tirzepatide in primary care settings has started in the UK. News Limited prostate cancer screening backed in UK A recommendation on prostate cancer screening has been delivered in the UK, upsetting patient groups whilst being endorsed by medical organisations. more
News FDA could hike user fees for ex-US drug programmes FDA mulls reduced fees for programmes with US-based phase 1 trials, and higher fees for those tested overseas, to incentivise US R&D.
News FDA takes steps to limit non-human primate testing New draft guidance from the FDA says single-target antibodies will no longer need six-month toxicity testing in animals like macaques.
News FDA doubles down on its push into AI The FDA has revealed the latest element in its adoption of AI, an agentic AI platform that agency staffers can use to streamline complex tasks.
News UK and US agree zero tariffs on pharma – with price rises A deal between the UK and the US will maintain tariffs on imports into the US at 0%, but prices of medicines used by the NHS will go up.
Market Access How are the US MFN and German MFG likely to impact pharmaceu... A comparison of the US MFN and German MFG.
News Bayer gets EU approval for menopause drug Lynkuet Bayer now has approval on both sides of the Atlantic for Lynkuet, with the EU backing it for symptoms caused by both menopause and breast cancer.
News Approvals extend use of Roche, AbbVie drugs in lymphoma Patients in the US and EU with follicular lymphoma have new treatment options, thanks to new approvals for CD20xCD3 bispecifics Lunsumio and Epkinly.
Market Access Beyond the Bill: how do we make medicines affordable without... Two pharmaceutical giants have paused investment in the UK. More than a setback for British life sciences, it’s a warning sign for the future.
News Slow recruitment still hitting UK trials, says pharma Despite efforts to improve the environment for UK clinical trials, the sector is still facing headwinds like low recruitment rates and rising costs.
News UK and US agree zero tariffs on pharma – with price rises A deal between the UK and the US will maintain tariffs on imports into the US at 0%, but prices of medicines used by the NHS will go up.
News Real-world trial of Lilly's tirzepatide starts in UK A real-world study exploring the long-term effects of Eli Lilly's weight-loss therapy tirzepatide in primary care settings has started in the UK.
News Limited prostate cancer screening backed in UK A recommendation on prostate cancer screening has been delivered in the UK, upsetting patient groups whilst being endorsed by medical organisations.
