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I started the morning reading this story of how a botched football kick may have saved someone’s life. The need-to-know this morning Novartis shares were down in early trading after the company reported a drop in sales and operating profit in the first quarter, with generic competition hitting drugs like Entresto hard.
The company affirmed its guidance for the year, with net sales expected to grow in the low single digits, and core operating profit forecasted to decline slightly. The FDA has taken further actions to withdraw the approval of Amgen’s rare-disease drug Tavneos and remove it from the market.
Tavneos was approved in 2021, but new information indicates the drug is ineffective and the application used to support approval contained “untrue statements of material fact,” the FDA said. Amgen has refused to withdraw Tavneos voluntarily, insisting the drug is safe.
The piece highlighted corporate earnings, regulatory action, and a new collaboration in gene editing, alongside a human-interest anecdote.
The article was presented as a morning briefing for subscribers.
The company maintained its full-year guidance, projecting low single-digit net sales growth and a slight decline in core operating profit.
The agency stated that new information demonstrates ineffectiveness and that the application supporting approval contained “untrue statements of material fact.” Amgen declined to voluntarily withdraw the drug and has maintained that Tavneos is safe.
No further technical or timeline details were provided in the excerpt.
The referenced human-interest item and invitation to subscribe indicate that fuller articles and additional details are behind the STAT+ paywall.