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Helixgate

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How a group of biotechs ran a covert campaign to push out the FDA commissioner

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Biohaven CEO Vlad Coric finally had the attention of the FDA, and most importantly, Commissioner Marty Makary.

In late April, after the company’s spinocerebellar ataxia drug had been rejected last year, Coric had won a …

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Amgen shores up Tavneos’ FDA defense with Duke data analysis

Amgen shores up Tavneos’ FDA defense with Duke data analysis

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After the FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos and called for its voluntary removal, the pharma recruited an independent data analysis from Duke researchers to help build the case for the drug’s continued market approval.​ ​Read More

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Chile offers new data on food warning label efficacy

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.

So much news today that I didn’t have space to write an item about hot tubs as a breeding ground for Legionnaires’ disease. Here’s the CDC report, if you’re curious.

Read the rest…

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Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.

So much news today that I didn’t have space to write an item about hot tubs as a breeding ground for Legionnaires’ disease. Here’s the CDC report, if you’re curious.

Read the rest…

Read More

Continue Reading

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Novartis’ $12B Avidity buy pays dividends with Phase 1/2 muscular dystrophy win

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The RNA-based medicine is one of a handful of antibody-oligonucleotide conjugates that Novartis acquired last October when it took over neuromuscular-focused Avidity Biosciences.

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