regulatory
U.S. Biotechs Reveal Tariff Exposure as Trade Inquiry Signals Imminent Pharmaceutical Tariffs
U.S. biotech, pharmaceutical tariffs, Section 232 investigation, supply chain exposure, trade policy, import costs, reshoring manufacturing, drug pricing, global supply chain, pharmaceutical ingredients, regulatory impact
Navigating the Biotech Winter: Strategies for Survival and Growth Amid Ongoing Industry Downturn
biotech downturn, layoff trends, funding challenges, strategic adaptation, innovation, mergers & acquisitions, workforce planning, precision medicine, artificial intelligence, regulatory landscape, survival strategies, growth opportunities
Biopharma Layoff Trends in Q1 2025 and Outlook for Q2
Biopharma layoffs, Q1 2025 layoffs, biotech job cuts, pharma workforce reductions, restructuring, patent cliffs, regulatory challenges, Q2 layoff forecast, pharmaceutical employment trends, biopharma industry changes.
Massive FDA Staff Cuts Jeopardize Drug and Device Review Processes, Threatening Critical User Fee Programs
FDA layoffs , Drug review delays , User Fee Programs , PDUFA , Regulatory challenges , FDA budget cuts , Medical device approval , Biopharma regulatory issues , RFK Jr. HHS layoffs , FDA operational disruptions
Biotech Restructuring and European Regulatory Setbacks
LifeMine Therapeutics, layoffs, PTC Therapeutics, Translarna, Duchenne muscular dystrophy, European Commission, regulatory decision
Incyte’s oral HS drug hits study goals, but fails to excite investors
povorcitinib, JAK1 inhibitor, hidradenitis suppurativa, Phase 3 trials, efficacy, investor reaction, regulatory submission
FDA Pauses BioNTech’s Malaria Vaccine Trial Amid Regulatory Scrutiny
BioNTech, malaria vaccine, FDA clinical hold, RNA vaccine, regulatory challenges
The Perfect Storm: Why 2025 Will Be the Year of GxP AI in Pharma
GxP AI, pharmaceutical manufacturing, regulatory compliance, data-driven innovation, quality management, drug development
EU PFAS Ban Threatens Pharmaceutical Packaging Industry: Challenges and Implications
PFAS ban, pharmaceutical packaging, EU regulations, supply chain disruption, chemical alternatives, environmental protection, drug safety
Stoke Therapeutics Announces Global Phase 3 EMPEROR Study Design for Zorevunersen in Dravet Syndrome
Dravet syndrome, zorevunersen, Phase 3 trial, EMPEROR study, seizure reduction, cognitive improvement, regulatory alignment