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In a letter to President Donald Trump, a group of biotech executives recommended former cancer regulator Richard Pazdur to lead the agency after the departure of Marty Makary.
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European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
IPO
After years of suffering from a bear market and more than 14 months of geopolitical turmoil shaking the macroenvironment, biotech appears to be moving on.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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The company, launched with help from ex-Novartis executives, is targeting glutamate signaling in the brain to help treat alcohol- and cocaine-use disorders, among other indications.
Novo will license UTB251, a triple hormone receptor agonist that in mid-2023 achieved 24% weight reduction at 48 weeks in a mid-stage study.
The investments come amid an ongoing insurance fraud probe into AstraZeneca’s former China head Leon Wang—and despite mounting pressure from President Trump for pharma companies to re-shore their manufacturing operations.
AbbVie claims that Genmab turned a blind eye to trade secret theft allegedly used to support the development of ProfoundBio’s investigational antibody-drug conjugates. Genmab acquired ProfoundBio in May 2024.
In attempt to keep R&D costs low, the vivarium business model has emerged as a crucial solution for drug developers.
It’s early days for xenotransplantation, but eGenesis, Eledon, United Therapeutics and more are working to develop solutions to make this approach a viable option and help ease the organ shortage crisis.
Biosimilars are essential healthcare equalizers, but their regulation is overly complicated due to lobbying by makers of branded biologics looking to maintain blockbuster revenue.
Since 2016, the FDA has approved three disease-modifying treatments for spinal muscular atrophy, with several companies—including Novartis, Scholar Rock and Biogen—progressing novel candidates through clinical trials.
Johnson & Johnson follows Eli Lilly in spending billions on U.S. manufacturing after President Donald Trump threatened major tariffs on pharmaceutical products. Pfizer has also promised a similar commitment.
This is the third indication for Fabhalta after Novartis won FDA approval of the small molecule in paroxysmal nocturnal hemoglobinuria and primary immunoglobulin A nephropathy.