Policy
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
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Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
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Throughout her defense, she cast blame for Theranos’ troubles on her former partner and lover, Ramesh “Sunny” Balwani, as well as subordinates who she claimed misled her.
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The counterclaim by an alleged victim of MIT professor David Sabatini said she was coerced into sex and that Sabatini’s laboratory had a “toxic and sexually charged” environment.
Vyera Pharmaceuticals agreed to pay $40 million to settle federal allegations to radically increase the price of toxoplasmosis drug Daraprim and prevent generic competition.
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