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In this episode of Denatured, you’ll be hearing from Miguel Forte, president of the International Society for Cell and Gene Therapy (ISCT), and John Ellis, co-founder & CEO of Trenchant Bios, speaking live from the ISCT annual meeting. We dive into mesenchymal stem cells and induced pluripotent stem cells, exploring the science behind them, the manufacturing challenges, and the potential for scalable, engineered next-generation therapies.
FEATURED STORIES
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.
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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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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A revised Paxlovid supply agreement with the U.S. government has pushed Pfizer to launch a “cost realignment” program including layoffs, though it is still unclear how many employees will be affected.
The first two weeks of October saw BMS’s $4.8 billion buyout of Mirati, Lilly’s $1.4 billion purchase of Point, Kyowa Kirin’s $387 million acquisition of Orchard and AbbVie’s $110 million Mitokinin deal.
The regulator’s approval of oral, once-daily etrasimod, to be marketed as Velsipity, was based on favorable Phase III safety and efficacy data showing significant clinical remission of ulcerative colitis.
Last year, the FDA declined to approve a drug that appears to reverse a rare and debilitating enzyme deficiency. Some experts say it’s emblematic of a need for more flexibility around therapeutics targeting rare diseases.
The biotech will pause its lirafugratinib program for a rare bile duct cancer to target a larger FGFR2-altered solid tumors population, citing the Inflation Reduction Act as a driving decision factor.
The biopharma’s data manipulation controversy continues with a recently leaked City University of New York report, which found signs of “egregious” and “deliberate” misconduct by a company advisor.
The German biotechnology company has teamed with Suzhou-based biotech MediLink Therapeutics to develop next-generation antibody-drug conjugates for cancer.
The FDA is gearing up for six decisions in the next two weeks, two of which involve highly anticipated medicines for rare diseases.
Shares of Akero Therapeutics took a hit after the company missed the primary endpoint in a Phase IIb study of efruxifermin in nonalcoholic steatohepatitis.
More than 54% of patients treated with mirikizumab achieved clinical remission at 52 weeks versus 19.6% of those on placebo. Eli Lilly will submit a marketing application in Crohn’s disease to the FDA in 2024.