September 16, 2026
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National Biotech Reporter
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regulation

FDA starts program to get drugs in the clinic faster

The FDA is opening applications for a pilot program designed to speed up the timeline for drugmakers to enter the clinic.

Typically, companies must complete a time-consuming series of steps before getting approval to start human trials, such as conducting pharmacology and toxicology studies and generating manufacturing and chemistry data.

The pilot program seeks to speed up that process up by creating a network of “qualified research institutions” that will partner with companies to develop and review their applications for starting human trials. The agency will also offer rolling feedback on companies’ applications before the formal submission.

Read more from STAT's Margaret Manto.



politics

Democrats plan health care probes after midterms

If Democrats win control of the House or Senate in the upcoming midterm elections, we may soon see aggressive investigations into President Trump's health policies, including the drug-pricing deals he's made with pharma companies.

When a party takes control of a chamber, it's commonly turned to using oversight powers to focus on what the opposing party has done. One professor pointed out that many of Democrats' recent health care efforts, like the Medicare drug-price negotiation program, originally stemmed from oversight probes.

Read more from STAT's John Wilkerson.


politics

Warren wants the receipts

From STAT's Chelsea Cirruzzo: At a confirmation hearing yesteday, Sen. Elizabeth Warren demanded to see the drug-pricing deals struck between the Trump administration and pharma companies, accusing health secretary Robert F. Kennedy Jr. of hiding them.

She also suggested the deals are making far less of an impact on the drug industry than President Trump has promised.

“If these deals were in fact so good, so profitable for the United States, then I would expect that they would lower big pharma's profits. But what executives are telling their investors is not so much,” she said to Chris Klomp, who has been nominated to become the No. 2 federal health official.

The White House has signed deals with 26 drugmakers that may exempt their drugs from certain mandatory price reductions in Medicare and from tariffs. In turn, the companies would sell drugs to U.S. patients at prices comparable or lower to peer nations, as part of the Trump administration’s "most-favored nation" policy. But the details of these deals have remained secretive.

In April, Warren asked Kennedy at a congressional hearing to provide those contracts. But yesterday, she told Klomp that he has yet to provide them.

Mr. Klomp, was Secretary Kennedy lying when he said he would make those deals available to us?” she asked.

“I don't believe he was lying,” Klomp responded, adding that the contracts needed to be redacted of proprietary information, but “the results of everything,” or the savings generated by the deals, is available.

“There are no contracts that are available that I can see who made how much money on what deal. I have your general summary, but that's not what I asked the secretary for, and it's not what the secretary promised to deliver,” Warren responded.

She said the contracts will better shed light on how the deals are benefiting Americans.

“Earlier this month, biotech company Incyte Corporation wrote in its earnings report that it does not expect its deal with the Trump administration to “have a material impact on its future financial outlook,’” she said.“The companies are saying they are immaterial, and you still want the American people to believe that they will somehow have a really great deal for our country that will get great prices. Show me the receipts,” she said.

Klomp responded that he could not divulge trade secrets. “We’re not hiding anything,” he said.

“I know that you wouldn’t want to do something that would compromise the U.S. government's ability to continue negotiating, which we are actively negotiating with other countries,” he added.

“No, these are contracts that are already written,” Warren shot back before moving on.


More around STAT

More reads

  • Montana’s giving the biotech industry sweeping authority to sell unapproved drugs, Politico
  • Medicare to expand its pilot that pays for technology to manage chronic diseases, STAT


Thanks for reading! Until next time,

 
STAT