Policy
After withdrawing its nomination for Dave Weldon last week, the Trump administration is now reportedly considering Texas Republican Michael Burgess to head the Centers for Disease Control and Prevention.
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Marty Makary, likely FDA commissioner under President Trump, appeared before Congress this week as the agency he’s set to lead continues to be rocked by sweeping changes and about-faces.
Konstantina Katcheves, Senior VP of Innovative Global Business Development at Teva Pharmaceuticals brings insights from the World Economic Forum to SCOPE 2025.
In the current legal and political landscape, it is all about survival for DEI initiatives.
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BioSpace remembers COVID-19 five years after the pandemic was declared, Novo Nordisk’s CagriSema again misses expectations as the company joins a lawsuit filed by drug compounders against the FDA, Viking secures ample supply of its investigational obesity medication, J&J strikes out in depression, and Makary and Bhattacharya near confirmation.
Days after suffering a rejection in Australia, the Alzheimer’s drug hit another roadblock in the U.K., which found the drug not cost-effective.
Analysts at Jefferies see Makary as a positive for the rare disease space, given his support for accelerated approvals and openness to “customizing regulatory pathways for rare diseases.”
The Senate hearing for FDA Commissioner nominee Marty Makary comes after President Trump’s NIH pick, Jay Bhattacharya, was grilled by the legislative body on Wednesday.
The last few years have been tough for the insulin market, with recent policies and high-level pressure forcing companies to lower drug prices.
Pfizer reacts to Donald Trump’s tariff threats on big pharma, another regulatory meeting is canceled under RFK Jr., AbbVie and Eli Lilly strike mid-sized deals in obesity and molecular glues, priority review vouchers set to take a hit and immuno-oncology matures.
Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that will apply to all EU member states as well as Norway, Liechtenstein and Iceland.
In the five weeks since Donald Trump returned as U.S. president, the FDA, NIH and CDC have been thrown into disarray, with meetings regarding vaccines and rare diseases canceled or indefinitely postponed—all without a clear reason why.
The back-to-back high-level disruptions in vaccine policy under Robert F. Kennedy Jr. comes as the U.S. records its first death from measles since 2015.
While many industry players and observers have high hopes for the EPIC Act, some say budgetary headwinds could make it difficult for the current administration to make meaningful repeals or amendments to the IRA.