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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Shares of Kura Oncology have plunged nearly 30% in premarket trading after the FDA placed a partial clinical hold on the company’s Phase Ib leukemia study following the report of a patient’s death.
The FDA approved Takeda’s Livtencity (maribavir) for adults and children 12 years or older with post-transplant cytomegalovirus (CMV) infection.
A preprint in bioRxiv from Penn State showed SARS-CoV-2 was detected in 33% (94) of the 283 white-tailed deer tested in Iowa between November 23, 2020 and January 10, 2021.
Tonix expects to begin enrollment in the trial for TNX-1900, an intranasal potentiated oxytocin, during the second half of 2022.
The U.S. FDA is making up for Covid-lost time this year, doubling the goal for FY 2021 domestic surveillance inspections for food and medical manufacturing facilities.
The U.S. CDC has issued new travel warnings as surges of COVID-19 continue throughout the country and the world. For that and other COVID-19 news, read below.