August 12, 2025

The need-to-know this morning

Bayer is licensing a KRAS G12D inhibitor from Kumquat Biosciences in a deal worth up to $1.3 billion.

oncology

Pfizer drug with Keytruda extends bladder cancer survival

Pfizer said this morning that its antibody-drug conjugate Padcev extended survival when combined with the cancer immunotherapy Keytruda in patients with invasive bladder cancer who could not take or refused the chemotherapy cisplatin.

A planned early analysis of the study found that giving Padcev and Keytruda both before and after removal of the bladder both lengthened the amount of time before the tumor returned and the overall amount of time patients lived compared to those who had surgery alone.

Pfizer did not release details of how the group of patients who took the combination compared with another group that used Keytruda alone.

oncology

Elicio's peptide vaccine shows early promise

Elicio Therapeutics' experimental peptide vaccine induced an immune response in a small study of patients with pancreatic and colon cancers, suggesting it may have potential to help prevent cancer relapse, though more studies are needed.

The study recruited 25 patients who had completed standard treatment and were at a high risk of relapse. Researchers found that the vaccine induced an immune response and elevated levels of two types of T-cells in over 70% of participants. The study also determined that those who experienced an increase in their T-cell count of over ninefold had significantly better outcomes than their counterparts who did not.

pharma

In DTC world: questions surround a company with ties to Trump Jr.

Bloomberg reported that BlinkRx, a company that has Donald Trump Jr. on its board, just released a new service to help pharma companies quickly create direct sales platforms. This comes after President Trump demanded firms sell drugs directly to consumers as part of his "most-favored nation" policy.

Trump has ordered major pharma companies to implement direct-to-consumer distribution models for "high-volume, high rebate" drugs as part of his plan to lower U.S. drug prices in line with what other countries pay. Experts have questioned, though, whether that model would actually increase access and affordability.

BlinkRx denied that there's a conflict of interest, saying it "did not speak to anyone at any level of government about the order," Bloomberg reported.

regulation

A memo to Prasad: try to fade into the background

As Vinay Prasad returns to the FDA after his sudden ouster, my colleague Matt Herper writes that he should try to listen more, embrace dissent, and fade into the background.

"FDA officials tend to make their best decisions when they ignore politics and listen to their staff. And they make their worst ones when they do the opposite," Matt writes.

vaccines

NIH director says the public lacks trust in mRNA tech

Jay Bhattacharya, head of the National Institutes of Health, said that the U.S. government recently canceled $500 million in contracts to help develop messenger RNA vaccines because the public doesn't trust the platform.

"As far as public health goes, the mRNA platform for vaccines is no longer viable," Bhattacharya said on right-wing provocateur Steve Bannon's podcast that aired over the weekend. "You can't have a platform where such a large fraction of the population distrusts the platform, if you're going to use it for vaccines, and expect it to work."

Notably, Bhattacharya's rationale does not align with the explanation offered last week by his boss, health secretary Robert F. Kennedy Jr., who said vaccines made using this platform were not effective and were unsafe.