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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Moderna has decided to drop the patent application to “allow more time for discussions with the NIH”, which will be aimed at an amicable resolution.
As the spread of the Omicron variant of COVID-19 picks up speed, vaccine makers are rushing to test their shots against the new mutation, with mixed results.
Biogen and Eisai reported that the Committee for Medicinal Products for Human Use of the European Medicines Agency had decided not to recommend the drug for its MAA.
With the holidays around the corner and people expected to gather, public health officials have expressed concerns over a possible increase in COVID-19 cases, particularly with the highly infectious Omicron variant on the rise.
U.S. District Judge Colleen McMahon rejected a bankruptcy plan that shielded the Sackler family from potential lawsuits related to the opioid crisis.
In a unanimous vote made by U.S. health officials, the advisers decided the safer Pfizer and Moderna vaccines should be given as boosters.
BeiGene and other China-based pharma companies have been nervously watching the Biden administration and its response to some companies in that region that have allegedly been involved with the Chinese military’s weapons programs and human rights violations.
A recent study estimates that in the U.S. alone the vaccines saved 1.1 million lives and prevented 10.3 million hospitalizations. For that and more COVID-19 news, continue reading.
As the Omicron variant of the SARS-CoV-2 virus sweeps much of the globe, scientists are digging into why this particular mutation is spreading even more rapidly than its predecessors.
Shares of BeiGene have fallen 16% in China in part due to concerns over potential U.S. sanctions against Chinese biotech companies.