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 · 6h 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 · 9h ago↗ source
- US lawmakers push FDA to tighten rules on Chinese clinical data after three gene therapy deathsThree recent deaths in separate gene‑therapy trials in China have prompted two members of the U.S. House of Representatives to call on the FDA for new safeguards. Representatives John Moolenaar an…