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Good morning. Some exciting news on the newsletter front — my colleague Brittany Trang will be writing a new weekly newsletter, called AI Prognosis, about AI’s growing impact in health care, scientific research, and medical innovation. AI is expanding and changing faster than formal regulations and expert guidance can keep up, and Brittany will be there to help decode all of the developments. The newsletter is slated to launch in February, sign up here.
Now, onto the biotech news today.
What Makary’s past may tell us about his future at FDA
President-elect Trump’s pick to lead the Food and Drug Administration, Marty Makary, has made a name for himself by challenging status quo ideas in health care. But what kind of an FDA commissioner might Makary be?
To get some clues, my colleague Lizzy Lawrence took a deep look into his past, from his early days studying clinical best practices and medical errors to his transformation into a loud critic of the government’s Covid-19 response.
Speaking with his colleagues and others in the public health world, Lizzy learned that some consider Makary to be a fearless truth-teller and an independent thinker with a deep respect for science and evidence, while others consider him a contrarian for contrarian’s sake, opining on matters outside of his expertise for political clout.
Pfizer guidance leaves room for debate
From my colleague Matt Herper: Pfizer this morning said it expects its sales and earnings for 2025 to bracket the forecasts of sell-side analysts and investors, leaving room for debate on a company whose stock has struggled since its highs during the Covid pandemic.
The drug giant, which makes breast cancer drug Ibrance, pneumococcal vaccine Prevnar, and the heart drug Vyndaqel, said it expects sales next year to fall between $61 billion and $64 billion, and that diluted earnings per share, a key measure watched by investors, would range between $2.80 and $3.00 per share.
Financial analysts polled by Visible Alpha had expected earnings per share of $2.89 and sales of $63.2 billion. Pfizer has struggled to live up to the expectations investors built up after it developed the first Covid vaccine with BioNTech. Investors are probably more concerned with Pfizer’s long-term financial health and, in particular, its research pipeline than its 2025 sales.
Congress nears deal to rein in PBMs
After two years of debate, Congress has nearly reached a deal to rein in pharmacy benefit managers as part of a government funding package lawmakers are planning to pass before the end of the year, according to sources.
Measures expected to be included in the package would prohibit PBMs from linking their payments to drug prices in Medicare, increase transparency, and regulate how PBMs get paid for drugs by Medicaid programs.
As part of this government funding package, lawmakers are also expected to extend pandemic-era telehealth flexibilities in the Medicare program for two years.
Read more from STAT’s Rachel Cohrs Zhang.
This morning, we’ve also published an opinion piece by David Balto, an antitrust lawyer who served as the policy director of the FTC’s Bureau of Competition in the late 1990s. He argues that PBMs should be worried under a second Trump administration. Read that here.
Who was the best biopharma CEO of 2024?
As we near the end of the year, it’s yet again time for my colleague Adam Feuerstein to announce his annual pick for the Best Biopharma CEO.
Spoiler — he doesn’t name a best CEO. He didn’t think any one stood out enough individually over the others. Still, he compiled a list of CEOs whose accomplishments he thought were worth shouting out.
The list includes Amylyx co-CEOs Joshua Cohen and Justin Klee, former Karuna CEO Steven Paul, and Bristol Myers Squibb CEO Chris Boerner, as well as several others.
Read on to see why Adam thought these CEOs were worth mentioning.
Gameto says first baby born using new stem-cell tech
From my colleague Megan Molteni: Earlier this month, the first baby created with a new “lightweight” form of IVF was born in Lima, Peru. The birth was announced yesterday by Gameto, a New York City-based startup that is developing an ovary-in-a-dish derived from human induced pluripotent stem cells.
As I wrote about last year, Gameto’s technology is aimed at reducing the number of hormone injections IVF-seekers have to take — which are costly, painful, and come with numerous side effects — by maturing eggs outside the human body instead.
The company has already launched its lead product, Fertilo, in five countries including Peru and Australia, where such IVF practices are unregulated. In the U.S., the FDA has designated Fertilo as a biologic, Gameto’s CEO Dina Radenkovic told me this week.
The company, which raised $33 million in a series B in May, is expecting to launch a Phase 3 trial in early 2025, pending the go-ahead from the FDA. If it goes forward, it would be the first pivotal trial of induced pluripotent stem cells in the U.S.
“Women’s health often feels like taking a Time Machine and going backwards,” Radenkovic said. “So I’m incredibly excited for this biomedical first to happen in women’s health.”
More reads
- Merck drops TIGIT asset and LAG-3 program, discontinuing several phase 3 trials, Fierce Biotech
- Taxi drivers are steering neuroscience toward better understanding Alzheimer’s, STAT
- New model enables simpler, cheaper estimate of heart failure risk, STAT