Elaine Chen , 2025-04-30 13:27:00
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Good morning, let’s get into all the updates from a busy earnings season so far.
The need-to-know this morning
- GSK and United Therapeutics reported earnings.
- Novartis is acquiring Regulus Therapeutics, developer of an experimental treatment for ADPKD, an inherited type of kidney disease, for $800 million upfront plus another $900 million contingent on the drug’s approval.
BridgeBio delivers a big beat with new heart drug
BridgeBio’s recently approved heart drug brought in $36.7 million in sales in the first quarter, blowing past expectations. (Analysts had estimated $12 million, but Wall Street’s “whisper number” was $17 million to $20 million.)
The new numbers show that the biotech is off to a promising start with its drug, called Attruby, launched last November. The company is becoming a more formidable player in the space just as Alnylam starts to launch its competing drug, which was approved last month.
For years, Pfizer was the only drugmaker with treatments for the disease, called ATTR-CM, but BridgeBio’s CEO said in an interview that there’s room for other products as more doctors become aware of the disease and patients get diagnosed earlier.
Pfizer CEO thinks pharma tariffs won’t be applied equally
From my colleague Adam Feuerstein: On the pharma giant’s earnings conference call yesterday, Pfizer CEO Albert Bourla offered a noteworthy take on the possibility of pharmaceutical tariffs.
The Trump administration is motivated at least partially by national security concerns, Bourla said, which could lead to different tariff rates for countries deeemed “friendly” or “adversary.”
“I think no country wants to have critical medicines produced outside of the country, particularly, they don’t want to have critical medicines produced in countries where tensions are high or can escalate,” said Bourla.
He added that China’s rapidly advancing biotech industry could also be viewed as a national security threat:
“The thing that I discuss with everyone in the administration, and I think that resonates a lot with Democrats and with Republicans, with everybody in the administration, including HHS and everywhere, is that China right now is progressing with the speed of light in their science. Biotech, it is dominant.
The U.S. has the dominant scientific position in biotech because we have created this ecosystem of biotech and pharma and academia and all of that. This is exactly what the Chinese have replicated in the last four years. And in the last four years, there was a significant setback [with IRA] for the U.S. that took down a lot of funding for private sector biotechs.”
A tariff scheme that largely spares Ireland but punishes China would be a win for pharma, said Evercore ISI analyst Umer Raffat, in a note to investors.
The next big vaccine developments to watch
In the short time that RFK Jr. has been HHS secretary, he’s already shown that that the intends to use his extensive powers over regulation, policy, and research funding to influence Americans’ thinking about vaccines.
But over the next couple of months, he’ll will have many more opportunities to pursue his decades-long campaign against vaccines. My colleague Helen Branswell compiled a list of the key developments to watch.
In addition to scrutinizing how the FDA handles its review of Novavax’s Covid vaccine and Moderna’s next-generation Covid vaccine, she’s also looking at how health agencies will respond to advisory committees, as well as the fate of government contracts with vaccine makers.
A new smoking cessation drug is going before FDA
Achieve Life Sciences will soon file for approval of its drug, called cytisinicline, that aims to help people quite smoking. If cleared by regulators, it would be the first new drug for smoking cessation in 20 years.
There are currently only two medications on the market to help people stop smoking — the more effective of which can come with unpleasant side effects like nausea that make people less likely to stick with the treatment.
Pharma companies have shied away from developing new smoking cessation drugs, in part because the FDA has historically taken a cautious approach to reviewing that type of medication.
My colleague Sarah Todd sat down with Achieve’s CEO to talk about the data it’s collected and the company’s strategy for getting approval. Read more.
More reads
- Q&A: In conversation with FDA Commissioner Dr. Marty Makary, Inside Medicine
- Health systems in limbo as HHS stays quiet on nondiscrimination rules for AI, algorithms, STAT
- Opinion: A dangerous new push to ban embryonic stem cell research funding is gaining momentum, STAT
