source
- Regenxbio gene therapy refiling plan derailed by FDA hold over spine MRI findingsThe FDA has put a clinical hold on Regenxbio’s RGX-121 over asymptomatic spine MRI findings, derailing the biotech’s plans to refile for approval of the once-rejected gene therapy candidate.Fierce Biotech · 7h ago↗ source
- Roche pens $2.5B pact for Hanmi’s clinical-stage obesity drug targeting less-explored mechanismRoche has taken its obesity strategy into uncharted territory via a $190 million upfront payment for a clinical-stage urocortin-2 analog from South Korea’s Hanmi Pharm.Fierce Biotech · 11h ago↗ source
- Merck and Moderna report positive topline results for personalized cancer vaccineA third death was reported in China’s expedited clinical trials, raising safety concerns for fast‑track studies in the region. Merck and Moderna announced positive topline data from their personal…