Of all the stories we published this year, these deep dives by BioSpace editors stand out as relevant re-reads going into the New Year.
2025 has been a tumultuous year for biopharma, to say the least. After assuming office in January, President Donald Trump immediately started announcing policy changes that had sweeping effects on how the industry operates, from issuing tariffs on pharmaceutical imports to insisting that drugmakers lower their U.S. prices to be in line with the rest of the developed world. Meanwhile, the Department of Health and Human Services has undergone massive restructuring that has thrown drug regulation into a state of change and confusion.
Nevertheless, biopharma companies forged ahead with novel therapies and expanding markets. While many therapeutic areas made headlines throughout the year, the obesity space was undoubtedly the busiest. Eli Lilly and Novo Nordisk still lead the pack as we close out 2025, but the dynamics between the two frontrunners shifted notably this year. At the same time, dozens of biotechs are developing next-gen weight loss options and other Big Pharmas are scrambling to secure pipelines that will give them a piece of the pie—a market that could top $150 billion.
BioSpace covered it all, and choosing just five stories to highlight here was no easy feat. But read on to learn which we think are most worthy of your attention, especially if you missed them the first time around.
November 25
Eli Lilly made history this year when it became the first pharmaceutical company to hit a $1 trillion valuation. This milestone was achieved largely thanks to its blockbuster tirzepatide franchise—Zepbound for weight loss and Mounjaro for diabetes—which in the third quarter suprassed the all-time king Keytruda after just a few years on the market. Tirzepatide’s steep growth curve far outpaces the trajectory of Merck’s cancer stalwart, now in its 11th year on the market.
In this story, BioSpace’s Annalee Armstrong charted those growth curves, along with that of Lilly’s obesity rival, Novo Nordisk, whose semaglutide drugs have faltered after having first-to-market advantage. She also compiled revenue data for Zepbound and Mounjaro to display alongside their semaglutide competitors—Wegovy for weight loss and Ozempic for diabetes—creating an animated graphic that shows Lilly’s stunning sprint to market dominance.
December 3
The FDA has seen an unprecedented amount of turnover this year, starting with the massive DOGE cuts deployed across the Department of Health and Human Services in the spring and then continuing as many staffers walked away from the chaos. Nowhere was the turnover more glaringly obvious than at the highest levels of agency leadership.
After the forced resignation of Center for Biologics Evaluation and Research Director Peter Marks in late March, Jef Akst created a visualization of FDA senior leadership and learned that more than half of the FDA’s leaders had departed the agency in the previous six months. Then in early December, after the sudden retirement of newly appointed Center for Drug Evaluation and Research Director Richard Pazdur, she redid the analysis and found that the number was up to almost 90%. Only three names on the organizational chart from a year ago remain today.
The loss of institutional knowledge is profound, and the ease with which the new administration has gone through regulators is but one example of how the FDA and other agencies under Health Secretary Robert F. Kennedy Jr.’s umbrella are disregarding normal bureaucratic processes. As regulatory consultant Steven Grossman wrote for BioSpace, “The FDA is becoming deeply compromised and increasingly at risk of being permanently transformed in ways contrary to its mission, history and culture.”
August 4
Companies navigating the U.S.’ regulatory paths face an unusual challenge this year: FDA leaks. As Capricor Therapeutics CEO Linda Marbán told BioSpace’s Heather McKenzie, “When you run a public company, you have to be able to respond when the investors call you, and so if you don’t know first, you really are sort of put off your game.”
Marbán experienced this problem firsthand when Capricor was contacted by a journalist about the ouster of Nicole Verdun, the director of the FDA’s Office of Therapeutic Products, and told that Verdun and her deputy, Rachael Anatol, “were put on administrative leave because of an argument about our file,” she told BioSpace. The reporter further explained to Marbán that Prasad wanted to reject Capricor’s application but Verdun did not.
Another example highlighted in this story is the summer saga of Sarepta Therapeutics, when news of a third death associated with company’s gene therapy platform prompted the FDA to request the stoppage of all shipments of the Duchenne muscular dystrophy treatment Elevidys.
When asked how he and his patients first received updates about Elevidys during this time, Cincinnati Children’s Hospital’s Chet Villa responded: “It’s the press and social media. There’s always been a little bit of that, but the sheer volume and the seriousness of the information that’s being conveyed makes this a different time than usual.”
March 5
At the end of 2024, Congress failed to renew the 12-year-old rare pediatric disease priority review program, sending ripple effects across biopharma. Previously heralded as a massive success for encouraging biopharma to develop new treatments for rare diseases, no one has carefully tracked where the vouchers go, making it impossible to understand the full impact of the program’s expiry.
To get to the bottom of this question, Armstrong spent months combing through databases, federal records, old press releases and government reports to track down where the vouchers went and learned that the FDA gave out more of them in 2024 than ever before.
Her resulting research helped inform academics and companies as they lobbied for the program to be renewed. A bill proposing to get the PRV program moving again received bipartisan support in the House this month and now moves to the Senate. If the bill does not go through, companies with existing designations will only have until September 30, 2026, to get their drugs approved in order to earn a voucher.
July 2
The downfall of bluebird bio was definitely big news this year, as the once-darling of the gene therapy world was sold for a mere $50 million after once being valued at over $10 billion. Just as shocking: the flailing biotech’s buyers weren’t a bigger biopharma but two private equity firms, The Carlyle Group and SK Capital Partners.
To understand what interest these companies had in bluebird, Armstrong spoke with an investor who bought into bluebird at the end—and earned himself a decent return for it—alongside experts in private equity who could speak to the broader trend that might now be playing out: “the PE-ization of pharma,” as PitchBook Senior Biotech Analyst Kazi Helal put it.
Private equity has long been a player in pharma-adjacent specialties like contract research organizations, contract manufacturers and service providers, but actual drugmakers have been harder to crack, in part because of the nature of the risks involved in the industry and the long timeline for potential returns. But that is changing under pressure of a prolonged downmarket, Armstrong learned, providing an opening for private equity firms at a time that biotech executives really need a bailout.
