The need-to-know this morning
- Take a look at Abbvie earnings here, and Novartis earnings here.
- The European Commission has asked regulators to examine additional safety data on the Alzheimer's treatment Leqembi before rendering an approval decision, the drug's makers, Biogen and Eisai, said.
- Review staff at the European Medicines Agency recommended the approval of eight new medicines at its most recent meeting. The list is here.
- Daiichi Sankyo said CEO Sunao Manabe will step down in April, and will be succeeded by Hiroyuki Okuzawa.
pain
FDA approves Journavx, Vertex's non-opioid painkiller
Vertex Pharmaceuticals yesterday won approval for Journavx, a closely watched non-opioid pain drug for moderate to severe acute pain. The drug, which targets the NaV1.8 sodium channel, showed pain relief that was superior to placebo in trials — but it didn't outperform opioids in controlling pain, STAT's Jonathan Wosen writes.
Still, there's a pressing need for non-addictive pain treatments — and analysts predict up to $2 billion in peak sales.
"I think it's the socially responsible thing to prescribe something like this instead of opioids," Wolfe Research analyst Andy Chen told STAT. "I just don't think payers are going to enjoy the headline saying that, 'Oh, Mr. Payer is declining approval for [the] medication, and payers prefer that patients use opioids.' That would just be very bad PR."
Speaking of PR, curiously, the FDA issued this press release about the drug's approval despite the Health and Human Services Department's communications freeze.
Read more.
EXCLUSIVE
Biden's team quietly appointed new vaccine advisers
Before leaving office, the Biden administration appointed eight new members to the Advisory Committee on Immunization Practices (ACIP), part of an apparent effort to preserve its scientific integrity amid concerns about the Trump administration's stance on vaccines, STAT's Helen Branswell and Sarah Owermohle report.
The move, in theory, could make it more difficult for the Trump administration to shape the panel with its own appointees — but not impossible.
"I would think that you could almost guarantee that there's going to be some interference with the committee's work," an attorney and vaccine law professor at George Washington University told STAT. "I think that there will be anti-vax folks that see it as an opportunity to capture the committee, to reconstitute its membership."
Such an effort could be led by Robert F. Kennedy Jr., if he is confirmed as President Trump's pick as health secretary. On the second day of his confirmation hearings, RFK Jr. yesterday refused to say that vaccines don't cause autism, STAT's Rachel Cohrs Zhang and Matthew Herper write.
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