regulation
Which biotechs are affected by the government shutdown?
With the federal government shut down, the Food and Drug Administration is expected to feel a smaller hit than other agencies because it has user fee funding to fall back on. Commissioner Marty Makary tried to calm employees' fears about firings in a video earlier this week, saying he was able to "ensure an exemption because we are in the business of public safety."
However, the FDA will not be accepting new drug applications during the shutdown.
That could affect Moderna, Avidity Biosciences, Viridian Therapeutics, Cogent Biosciences, and Vera Therapeutics, which were all expected to complete their filings before the end of this year.
politics
Trump backs off of tariff threat, yet again
Last week, President Trump told pharma companies that if they don't start building infrastructure in the U.S., then they would face a 100% tariff starting Oct. 1 (yesterday). But a White House official told STAT yesterday that the tariffs have not gone into effect and that the administration would now "begin preparing" tariffs on companies that don't build in the U.S. or make a drug pricing agreement with the administration.
The official didn't share a new timeline.
Trump in the past few months has repeatedly threatened steep tariffs on imported pharmaceuticals but has yet to follow through on those threats. The latest postponement signals that these months of tough talk may ultimately be aimed at leveraging more voluntary commitments from drugmakers, such as the agreement Pfizer made earlier this week.
Read more from STAT's Daniel Payne.
biotech
Here are the key events to watch for the rest of the year
My colleague Adam Feuerstein is back with his regular update on the key stock-moving events to watch this quarter.
They include a presentation from Akeso and Summit Therapeutics on full Chinese results from their Phase 3 HARMONI-6 study of the cancer drug ivonescimab.
Bristol Myers Squibb is expected to post results from a Phase 3 study of its newly approved schizophrenia drug Cobenfy for a different indication — psychosis related to Alzheimer's disease.
Novo Nordisk is also due to report results of two Phase 3 studies testing its GLP-1 drug Wegovy in Alzheimer's.
Read on for the full list of events.
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