Investigative

Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up?

September 21, 2023 / By / 3 Comments
Burst Biologics, Christopher Jones

The New York Times just broke a story on Burst Biologics and Weill Cornell that fits with long-standing troubling questions about regenerative biologics producers. The story also bears on the doctors and hospitals like Weill Cornell that were or are customers of the suppliers. Further, what is the FDA’s role in all of this? The …

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Questions on National Academies in vitro gametogenesis (IVG) meeting sponsorship

April 26, 2023 / By / 2 Comments
in vitro gametogenesis, IVG

Research on in vitro gametogenesis or IVG is jumping ahead and such work could one day lead to new infertility treatments. In vitro gametogenesis is the process of producing gametes (sperm and eggs) from stem cells. Those powerful stem cells, called iPS cells, can be made from ordinary adult cells like skin or blood cells. …

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FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics

November 23, 2022 / By / 3 Comments
Former FDA Commissioner Stephen Hahn.

An FDA FOIA dump of text messages of former Commissioner Stephen Hahn suggests that a Texas regenerative firm called Direct Biologics benefited from political pressure on him in mid-2020. Then he was asked again to help in early 2021. This was shortly before he resigned at the start of the Biden Administration. The push came from …

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