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InnovationRx: ‘The FDA As We Know It Is Finished’

Apr 02, 2025 - forbes.com
The article discusses significant developments in the healthcare and biotech sectors. It highlights the Trump administration's controversial layoffs at major health agencies, including the FDA, CDC, and NIH, which have raised concerns among scientists and industry leaders about the potential erosion of scientific standards and the impact on drug development. Additionally, it covers Palantir's lawsuit against Guardian AI, a Y Combinator-backed startup, for alleged trade secret theft, and the appointment of Karen Knudsen as CEO of the Parker Institute for Cancer Immunotherapy.

In the biotech and digital health space, Isomorphic Labs, a Google DeepMind spinoff, raised $600 million to accelerate drug discovery with AI, while Airna secured $155 million to advance RNA editing therapies for genetic disorders. The article also mentions Gather Health's innovative primary care model for older adults and the FDA's clearance of Bright Uro's Glean Urodynamics System. Other notable points include the potential impact of the Trump administration's stance on mRNA vaccines, Novo Nordisk's investment in an obesity drug, and a promising stem cell therapy for spinal cord injuries.

Key takeaways:

  • The Trump administration's health agency layoffs, including the forced resignation of FDA's Peter Marks, have raised concerns about the erosion of scientific standards and the impact on drug development.
  • Palantir Technologies has filed a lawsuit against Y Combinator-backed startup Guardian AI for alleged trade secret theft by former employees.
  • Airna, an RNA editing startup, raised $155 million to pursue clinical trials for treating alpha-1 antitrypsin deficiency and develop other RNA editing therapies.
  • Google DeepMind spinoff Isomorphic Labs raised $600 million to accelerate drug discovery with AI, partnering with companies like Eli Lilly and Novartis.
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