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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Researchers from A*STAR’s SBIC have discovered how changes in BCAA metabolism influence the development and progression of tumours, and pave the way for new approaches to prevent and treat certain cancers
The partial government shutdown is 31 days old, yet the U.S. Food and Drug Administration has maintained a steady list of drug approvals throughout that time. However, that approval rate could change next month.
China government officials told the Xinhua News Agency that the researcher who became world famous for using CRISPR on human embryos “will be transferred to public security authorities,” and the individuals involved in the research will be “severely dealt with according to the law.”
Last year was a record year for biotech initial public offerings (IPOs), but 2019 is off to a slow and rocky start because of the government shutdown, which today is in its 31st day.
The U.S. Food and Drug Administration (FDA) approved South Korea’s Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab).
Yesterday, the Endocrinologic and Metabolic Drugs Advisory Committee had a split vote, 8 to 8, on whether the overall benefits of Zynquista (sotagliflozin) outweiged the risk in order to support approval. This sends things back to the agency to make a final decision, which has a target action date of March 22, 2019.
Immunomedics was hoping for a green light from the U.S. Food and Drug Administration for its triple-negative breast cancer treatment, sacituzumab govitecan. However, this morning the company announced that approval will not likely be coming any time soon.
The Food & Drug Law Institute (FDLI) is pleased to announce the addition of two new members to the Board of Directors: Cathy Burgess, Partner, Alston & Bird; and Carla Cartwright, Director, Global Regulatory Policy, Johnson & Johnson.
The U.S. government has been pushing to increase access to experimental drugs over the last two years. On August 18, 2018, the RACE for Children Act was signed into law as part of the 2017 FDA Reauthorization Act, which amended the Pediatric Research Equity Act (PREA).
This follows a 2017 rejection by the agency, requesting more data. As Jefferies analyst Michael Yee wrote in a note to clients, Amgen is “back in the game.”