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Morning. Today, we dive into the Trump nominees for various top health postings in the federal government. Also, we talk about how Sarclisa trials highlighted racial disparities in clinical trial composition, and more.
The need-to-know this morning
- Merck said Winrevair, its treatment for pulmonary arterial hypertension, significantly reduced the risk of death, lung transplantation, or disease-related hospitalizations compared to a placebo — achieving the goal of a Phase 3 clinical trial.
- Alnylam Pharmaceuticals said the FDA has set an approval decision date of March 23 for vutrisiran, its treatment for the progressive heart disease known as ATTR-CM. At this time, the agency does not plan to convene an advisory committee meeting to review vutrisiran, the company said.
- Cassava Sciences said a Phase 3 study showed its experimental treatment sumifilam failed to slow the cognitive or functional decline compared to a placebo in people with Alzheimer’s disease. The company is also discontinuing a second Phase 3 study.
Weighing in on Trump’s health nominees
President-elect Trump’s intended nominations in health care could signal major shifts for some agencies, particularly the CDC. The presumptive new director, Dave Weldon, is a known vaccine safety skeptic, which is raising alarms given the CDC’s long history of eradicating disease with inoculation. A physician and former Florida congressman, he’s also pushed for “rights of conscience” on abortion.
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