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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There are plenty of great scientific research stories out this week. Here’s a look at just a few of them.
Lawsuit Charges FDA, NIH With Failing to Follow Established Law for Reporting of Clinical Trial Data
The lawsuit alleges that the government is letting a number of researchers off the hook of reporting clinical data.
Yesterday, the agency and Gottlieb doubled-down on the Action Plan and added to it. The FDA released two new draft Q&A guidance documents on biosimilar development and two final guidance documents on the same topics, as well as a proposed amendment to the definition of a biological product.
It seems like every time we turned around this year, there was an exciting or—on a more visceral level, “Hey, that’s cool!” science story. Here’s a look at the top 9 really cool life science discoveries of the year, from outer space, to peanut allergies, to tortoise genomes.
As the Trump administration has continued to show its lack of financial support of scientific research using fetal tissue, the National Institutes of Health is setting aside $20 million to fund research that could develop alternatives to the use of embryonic tissue.
Preparations to host Hemodialysis Congress, SIAL Middle East, International Date Palm Exhibition & IEEE Globecom Conference completed
It apparently began with a 2016 federal lawsuit. At that time, 20 state attorneys general filed a federal lawsuit alleging that six generic drug makers artificially inflated and manipulated prices for an antibiotic and an oral diabetes drug. The goal was to reduce competition.
Although a moderate presence in Europe, with about 25 biosimilars approved and on the market, they haven’t gained traction in the U.S. Even though at least 11 have been approved in the U.S., only about three are available, largely because of business tactics branded drug companies are using to slow down the competition to their typically very high-priced biologic drugs.
Many recent college graduates with science degrees wonder, “What other careers are available outside of a laboratory or research environment?” Concurrently, a large amount of mid-career and late-career professionals consider pursuing non-traditional science roles.
The U.S. Food and Drug Administration (FDA) released a new 2019 strategic Framework for how it plans to advance the use of so-called real-world data (RWD) to improve regulatory decisions. The agency has indicated that this is a strategic priority.