ICYMI: 5 BioSpace Options From 2025 That Stand the Check of Time
2025 has been a tumultuous yr for biopharma, to say the least. After assuming workplace in January, President Donald Trump instantly began saying coverage adjustments that had sweeping results on how the business operates, from issuing tariffs on pharmaceutical imports to insisting that drugmakers decrease their U.S. costs to be according to the remainder of the developed world. In the meantime, the Division of Well being and Human Companies has undergone large restructuring that has thrown drug regulation right into a state of change and confusion.
However, biopharma firms solid forward with novel therapies and increasing markets. Whereas many therapeutic areas made headlines all year long, the weight problems area was undoubtedly the busiest. Eli Lilly and Novo Nordisk nonetheless lead the pack as we shut out 2025, however the dynamics between the 2 frontrunners shifted notably this yr. On the similar time, dozens of biotechs are growing next-gen weight reduction choices and different Huge Pharmas are scrambling to safe pipelines that may give them a bit of the pie—a market that might high $150 billion.
BioSpace lined all of it, and selecting simply 5 tales to focus on right here was no straightforward feat. However learn on to be taught which we predict are most worthy of your consideration, particularly in the event you missed them the primary time round.
November 25
Eli Lilly made historical past this yr when it grew to become the primary pharmaceutical firm to hit a $1 trillion valuation. This milestone was achieved largely due to its blockbuster tirzepatide franchise—Zepbound for weight reduction and Mounjaro for diabetes—which within the third quarter suprassed the all-time king Keytruda after just some years in the marketplace. Tirzepatide’s steep development curve far outpaces the trajectory of Merck’s most cancers stalwart, now in its 11th yr in the marketplace.
On this story, BioSpace’s Annalee Armstrong charted these development curves, together with that of Lilly’s weight problems rival, Novo Nordisk, whose semaglutide medication have faltered after having first-to-market benefit. She additionally compiled income knowledge for Zepbound and Mounjaro to show alongside their semaglutide opponents—Wegovy for weight reduction and Ozempic for diabetes—creating an animated graphic that exhibits Lilly’s beautiful dash to market dominance.
The drugmaker’s dominance of the weight problems market is fueling predictions that years of development lie forward.
December 3
The FDA has seen an unprecedented quantity of turnover this yr, beginning with the huge DOGE cuts deployed throughout the Division of Well being and Human Companies within the spring after which persevering with as many staffers walked away from the chaos. Nowhere was the turnover extra manifestly apparent than on the highest ranges of company management.
After the pressured resignation of Heart for Biologics Analysis and Analysis Director Peter Marks in late March, Jef Akst created a visualization of FDA senior management and discovered that greater than half of the FDA’s leaders had departed the company within the earlier six months. Then in early December, after the sudden retirement of newly appointed Heart for Drug Analysis and Analysis Director Richard Pazdur, she redid the evaluation and located that the quantity was as much as virtually 90%. Solely three names on the organizational chart from a yr in the past stay immediately.
The lack of institutional information is profound, and the benefit with which the brand new administration has gone by means of regulators is however one instance of how the FDA and different businesses below Well being Secretary Robert F. Kennedy Jr.’s umbrella are disregarding regular bureaucratic processes. As regulatory guide Steven Grossman wrote for BioSpace, “The FDA is turning into deeply compromised and more and more liable to being completely remodeled in methods opposite to its mission, historical past and tradition.”
Whereas it’s common for sure positions to show over with a brand new administration, the variety of senior-level FDA staffers who’ve not too long ago left the company is unprecedented. The dearth of communication, transparency and human decency is as effectively.
August 4
Corporations navigating the U.S.’ regulatory paths face an uncommon problem this yr: FDA leaks. As Capricor Therapeutics CEO Linda Marbán informed BioSpace’s Heather McKenzie, “If you run a public firm, you’ve got to have the ability to reply when the buyers name you, and so in the event you don’t know first, you actually are kind of postpone your recreation.”
Marbán skilled this drawback firsthand when Capricor was contacted by a journalist concerning the ouster of Nicole Verdun, the director of the FDA’s Workplace of Therapeutic Merchandise, and informed that Verdun and her deputy, Rachael Anatol, “have been placed on administrative depart due to an argument about our file,” she informed BioSpace. The reporter additional defined to Marbán that Prasad needed to reject Capricor’s software however Verdun didn’t.
One other instance highlighted on this story is the summer time saga of Sarepta Therapeutics, when information of a 3rd demise related to firm’s gene remedy platform prompted the FDA to request the stoppage of all shipments of the Duchenne muscular dystrophy remedy Elevidys.
When requested how he and his sufferers first obtained updates about Elevidys throughout this time, Cincinnati Youngsters’s Hospital’s Chet Villa responded: “It’s the press and social media. There’s all the time been somewhat little bit of that, however the sheer quantity and the seriousness of the knowledge that’s being conveyed makes this a special time than standard.”
Since July, a number of biotechs have been pressured to pivot as earlier agreements with the FDA round proof required for approval have been reversed, a phenomenon that, in keeping with consultants, might portend a extra restrictive regulator.
March 5
On the finish of 2024, Congress did not renew the 12-year-old uncommon pediatric illness precedence evaluate program, sending ripple results throughout biopharma. Beforehand heralded as a large success for encouraging biopharma to develop new remedies for uncommon illnesses, nobody has fastidiously tracked the place the vouchers go, making it unattainable to grasp the total influence of this system’s expiry.
To resolve this query, Armstrong spent months combing by means of databases, federal data, outdated press releases and authorities reviews to trace down the place the vouchers went and discovered that the FDA gave out extra of them in 2024 than ever earlier than.
Her ensuing analysis helped inform lecturers and corporations as they lobbied for this system to be renewed. A invoice proposing to get the PRV program shifting once more obtained bipartisan help within the Home this month and now strikes to the Senate. If the invoice doesn’t undergo, firms with current designations will solely have till September 30, 2026, to get their medication authorised in an effort to earn a voucher.
A BioSpace evaluation of all 80 precedence evaluate vouchers which have been handed out throughout the three FDA applications that supply them discovered that 2024 was the busiest yr but. Corporations have disclosed spending $513 million on vouchers that have been earned in 2024 up to now.
July 2
The downfall of bluebird bio was positively huge information this yr, because the once-darling of the gene remedy world was offered for a mere $50 million after as soon as being valued at over $10 billion. Simply as surprising: the flailing biotech’s patrons weren’t a much bigger biopharma however two personal fairness companies, The Carlyle Group and SK Capital Companions.
To grasp what curiosity these firms had in bluebird, Armstrong spoke with an investor who purchased into bluebird on the finish—and earned himself a good return for it—alongside consultants in personal fairness who might communicate to the broader development which may now be enjoying out: “the PE-ization of pharma,” as PitchBook Senior Biotech Analyst Kazi Helal put it.
Personal fairness has lengthy been a participant in pharma-adjacent specialties like contract analysis organizations, contract producers and repair suppliers, however precise drugmakers have been more durable to crack, partly due to the character of the dangers concerned within the business and the lengthy timeline for potential returns. However that’s altering below strain of a protracted downmarket, Armstrong discovered, offering a gap for personal fairness companies at a time that biotech executives really want a bailout.
Bluebird bio has re-emerged after a non-public fairness buyout as Genetix Biotherapeutics, marking a return to its roots and a brand new path ahead for manufacturing.
