Policy
Jim O’Neill was deputy secretary at the Department of Health and Human Services and also acting director of the CDC after the abrupt ouster of Susan Monarez in August 2025.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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The U.S. Food and Drug Administration has a busy week planned for drug review. Here’s a look at this week’s schedule.
Now that global responses are fully mobilized, what is being done to identify and develop drugs and vaccines against this novel coronavirus?
Eisai indicated it was voluntarily withdrawing the drug, but in a statement noted it disagreed with the FDA’s interpretation of the data and believes the drug’s benefits outweigh the cancer risk.
Did the price of a newly-approved treatment for a rare autoimmune disease and pressure from U.S. Sen. Bernie Sanders lead to the approval of a rival treatment? That’s what Florida-based Catalyst Pharmaceutical is attempting to show in court.
Vela Diagnostics Submitting Novel Coronavirus Diagnostic Test to FDA for Emergency Use Authorization
Vela Diagnostics has developed the ViroKeyTM SA201 COVID-19 RT-PCR Test, a new diagnostic test for the detection of the COVID-19 coronavirus. Vela Diagnostics is currently in discussions with the U.S. Food and Drug Administration for clearance of the test under the emergency use authorization.
The therapy was also granted Rare Pediatric Disease designation for neuronopathic Gaucher disease, the most severe form of the condition.
Steve Hoerter, president and chief executive officer of Deciphera, said the acceptance of the NDA brings the company one step closer to its goal of providing a new treatment option for patients with advanced GIST.
A number of new medications stand a shot at early regulatory approval thanks to the U.S. Food and Drug Administration’s priority review program.
In November 2019, the U.S. Food and Drug Administration (FDA) released new draft guidance that would help generic drug companies bring biosimilars to insulin to the market more quickly. And now there are reports that two of the three primary biopharma companies that sell insulin in the U.S. are trying to change that draft guidance.
While fears of a potential coronavirus or flu pandemic continue to grow across the globe, the White House is calling for a 16% cut to the budget of the U.S. Centers for Disease Control, as well as a 10% cut to the Department of Health and Human Services.