Policy
Nader Pourhassan, who led CytoDyn for nearly 10 years, was convicted in December 2024 of misleading investors regarding the biotech’s investigational COVID-19 and HIV drug, which artificially inflated its share price.
FEATURED STORIES
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.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former U.S. Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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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.
The government alleged Actelion provided money to a nonprofit to cover copay costs for Medicare drugs, a violation of the False Claims Act.