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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The FDA had accepted the sBLA in September 2021 under priority review status.
The studies are of the U2 combination Ukoniq (umbralisib) and ublituximab for chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL).
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The FDA is calling the study a phase II trial and says the company must run a rodent genotoxicity study before it can continue.
Americans pay the highest drug prices in the world while importing drugs for lower prices from other countries has been locked down on a personal level and labeled as “unsafe.”
Pfizer hopes to step in to ensure that no trade secrets are disclosed when the regulatory agency begins to share that information.
Biogen and its partner Eisai Company released additional details about the Phase IV post-marketing study of the drug.
Cortexyme said it plans to provide additional updates pending further talks with the FDA.
Incyte’s decision follows consultation with the FDA, where it decided that it could not support any confirmatory studies that might be required in the future given the limited time frame.
The FDA placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine due to concerns of unexpected adverse events.