Catching up on earnings this week

It's been a busy week for earnings so far. Here's a recap of the key announcements:

Novo Nordisk shares were up this morning after a strong report showed continued booming sales of Ozempic and Wegovy. Still, the company faces questions about whether its growth might be slowing, and about its next-generation obesity drugs.
GSK announced a share buyback this morning as it raised its long-term growth forecast, citing progress with its late-stage pipeline.
Amgen, which reported earnings last night, said the FDA has a ordered a hold on its early obesity candidate, dubbed AMG 513, posing another potential setback in the company's efforts to join the booming weight loss drug market. Amgen has not yet disclosed the mechanism of this Phase 1 candidate.
Merck lowered guidance for this year's earnings and withdrew a target for sales of its HPV vaccine, Gardasil. While these updates may have help explain why the company's shares dropped 9% yesterday, investors also have underlying concerns about the fate of Merck's blockbuster cancer drug Keytruda, my colleague Matt Herper writes.

politics

RFK Jr.'s nomination moves forward, and NIH resumes grant reviews

And a roundup of the news out of D.C.:

RFK Jr. is now expected to win Senate confirmation to become HHS secretary, after his nomination cleared the Senate Finance Committee yesterday and a key Republican senator, Bill Cassidy, supported his confirmation.

The committee voted for Kennedy along party lines, 14-13, sending his nomination to the Senate floor for a vote, probably next week.

Cassidy, a physician, had expressed misgivings about Kennedy last week. But in a speech following the vote, Cassidy said Kennedy won him over by assuring him he would have more control over his actions as HHS secretary. Kennedy made promises such as meeting with Cassidy multiple times a month and seeking Cassidy's input on HHS hiring decisions.

Some health experts, though, were skeptical that Cassidy's promises to keep a close eye on Kennedy will dissuade Kennedy from weakening vaccine recommendations or sowing doubt about their value. Read more.

Stocks of vaccine makers dropped yesterday on the news, with Moderna falling 7% and Pfizer falling 1%.

Elsewhere, there seems to be a relaxing of certain Trump administration restrictions at health agencies. The NIH hosted the first study section to review grant applications in over two weeks, following an abrupt pause by the Trump administration on Jan. 22. Members of other study sections scheduled for this week also heard from NIH officials that their planned meetings would proceed as scheduled.

rare disease

Why patients can't get ahold of a rare disease drug

My colleague Ed Silverman brings us a complex story that highlights how difficult it is for rare disease patients to clear the hurdles of testing, high costs, and insurance to get access to treatments that can help them. Here's the gist:

An Amgen drug called Ravicti, which is approved to treat urea cycle disorders, has also been shown in studies to help treat rare forms of epilepsy.

The epilepsy patients, however, can't afford the drug, which can cost up to $863,000, and insurance plans aren't willing to cover the medication for this off-label usage. Amgen has provided the drug for free to epilepsy patients who were enrolled in a trial, but that free access ends this year.

Amgen also has little incentive to seek FDA approval of the drug for the epilepsy indication, because a generic version of Ravicti to treat urea cycle disorders could soon become available.