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Compass, Vertex, Novo Nordisk, Gilead


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Good morning! At this time, we get deeper into the ousting of Nicole Verdun on the FDA, see promise from Vertex’s cell remedy for diabetes, and unpack the story of creating the newly permitted Gilead PrEP drug lenacapivir.

The necessity-to-know this morning

  • Novo Nordisk terminated its advertising relationship with Hims & Hers, accusing the telehealth firm of misleading advertising practices and promoting “illegitimate” compounded variations of the weight-loss drug Wegovy. 
  • Compass Pathways reported outcomes from a Section 3 research of its psilocybin-based drug for treatment-resistant melancholy.

FDA ouster tied to Duchenne remedy conflict

The sudden removing of Nicole Verdun, the FDA’s high cell and gene remedy regulator, adopted a dispute along with her boss, Vinay Prasad, over holding a public advisory committee assembly on a cell remedy for Duchenne muscular dystrophy made by Capricor Therapeutics, STAT stories. Prasad unilaterally canceled the assembly, escalating inner tensions and resulting in Verdun and her deputy being positioned on administrative go away and escorted out of FDA headquarters — an unusually harsh transfer that shocked company employees and business alike.

Although Verdun confronted administration complaints, she was broadly revered for balancing urgency with rigor. The shakeup comes amid mounting concern over inconsistent regulatory requirements for high-stakes gene therapies. Notably, a number of company staff have advised STAT that Prasad is uninterested within the administrative facets of working CBER — which means that extra professional managers within the division are important.

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