The week in pharma: action, reaction and insight – week to August 22

By Barbara Obstoj-Cardwell

The US Food and Drug Administration (FDA) granted approval for a second treatment for metabolic dysfunction-associated steatohepatitis (MASH), Denmark-based Novo Nordisk’s Wegovy. US drugmaker PTC Therapeutics suffered a setback, as the FDA issued a complete response letter (CRL) on its new drug application (NDA) for vatiquinone, intended for the treatment of Friedreich’s ataxia (FL). USA-based Ionis gained FDA approval for its investigational hereditary angioedema (HAE) drug Dawnzera (donidalorsen). On the licensing front, Germany’ Merck KGaA entered into a collaboration with privately held US biotech Skyhawk Therapeutics on novel RNA-targeting selected neurological diseases.