STAT+: Pharmalittle: We’re reading about the FDA speeding up trials, a Supreme Court hearing on ‘skinny labels,’ and more
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- FDA will pilot real‑time data review for AstraZeneca and Amgen trials using Paradigm Health’s platform, aiming to slash regulator‑company data exchange time.
- Pfizer settled patent disputes with Dexcel Pharma and other generics, extending Vyndamax’s U.S. patent protection to June 1 2031 and preserving $6.4 billion in sales.
- Supreme Court justices signaled that “skinny labeling” survives, potentially allowing narrower drug labels and affecting generic competition.
- Marty Makary announced that reviewers will see safety signals and clinical endpoints directly on Paradigm’s platform, tightening oversight of AI‑enhanced trial monitoring.
Why it matters: Patients gain quicker access to innovative therapies as the FDA cuts trial timelines; Pfizer secures $6.4 billion in Vyndamax sales through 2031, while the Supreme Court’s skinny‑labeling decision narrows generic competition, driving higher drug prices.
