Market Access The value of a partner, globally and locally A new podcast looks at recent trends related to drug approvals, as well as challenges and opportunities both small and large pharma companies face
News FDA announces generative AI pilot and rapid rollout plans The FDA has completed a pilot of a new GenAI technology for speeding up drug reviews– And it wants to move from pilot to implementation in two months
News FDA ramps up unannounced inspections of foreign facilities Trump orders the FDA to ease the commissioning of domestic manufacturing facilities, as the regulator announces more unannounced foreign inspections.
News Vinay Prasad will replace Marks as CBER director COVID-19 vaccine mandate critic Vinay Prasad has been named as director of the FDA's Center for Biologics Evaluation and Research (CBER).
News Senior FDA resignations gut drug advertising function Two senior officials at the FDA's drug promotion office have resigned, leading to speculation that a clampdown on some advertising may be on the way.
Market Access Working in the grey: FDA, CMS and data privacy For companies in the biotech space, it’s never been easy to navigate the legal and business risks inherent in a highly regulated, dynamic industry – and it’s only becoming more complicated
News Lilly bags FDA okay for Wegovy pill rival orforglipron Eli Lilly has claimed US approval for oral GLP-1 agonist orforglipron, setting up a market clash with Novo Nordisk's first-to-market Wegovy pill.
Sales & Marketing Sponsored Using AI-driven synthetic personas to take your insights fur... As AI continues to reshape the healthcare landscape, pharma teams are beginning to leverage synthetic personas.