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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After Judge Denise Cotes banned Martin Shkreli from future involvement in the industry, a second judge handed down a similar order and ordered him to pay a $1.39 million fine.
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Health authorities in Malawi discovered an outbreak of wild poliovirus type 1 on Thursday. The announcement comes after a case was detected in a young child in Lilongwe.
The COVID-19 pandemic and the virus that causes it, SARS-CoV-2, has been resilient, unpredictable and confounding from the very beginning.
The U.S. Centers for Disease Control and Prevention is under fire for failing to publish large swaths of hospitalization data related to the COVID-19 pandemic.
A new packaging and labeling manufacturing facility has derailed the potential approval of Malinckrodt’s investigational hepatorenal syndrome (HRS) treatment, terlipressin.
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Prescription drug costs have continued to rise, with more than 150 drug manufacturers raising their prices in January.
The end of February picks up significantly from early this year for the U.S. Food and Drug Administration and its PDUFA dates.
Patient enrollment for the clinical trial, which was testing Atara’s autologous chimeric antigen receptor (CAR) T-cell immunology therapy called ATA2271, has been paused.