News

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.
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.
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.
THE LATEST
This labor market report examines Q3 life science job market trends and the recruitment outlook for Q4 and beyond.
FDA
Recent FDA approvals of novel drugs based on less-than-stellar clinical evidence point to a trend toward regulatory flexibility—particularly in indications with very high unmet need.
The Japan-based pharma is acquiring Orchard Therapeutics for approximately $477.6 million, if all conditions are met. Orchard’s pediatric gene therapy has a PDUFA date set for March 2024.
Following a fatality due to the rare blood disease hemophagocytic lymphohistiocytosis, the regulator slapped a partial clinical hold on two studies of Innate Pharma’s investigational therapy lacutamab.
Despite the lack of a randomized controlled trial for US WorldMeds’ investigational drug, an FDA advisory committee found that the company provided adequate data to support its benefit in high-risk neuroblastoma.
Patients with treatment-resistant depression treated with Johnson & Johnson’s Spravato were significantly more likely to reach remission and stay relapse-free for up to 32 weeks.
Data from the Mayo Clinic shows limited eligibility for the anti-amyloid treatment. However, Michael Irizarry, Eisai’s deputy chief clinical officer, says some patients could still be eligible.
AbbVie, Amgen, Gilead, Merck and Novartis are among the 31 members that have formed the Partnership for the U.S. Life Science Ecosystem to push back against federal antitrust reforms.
The pharmaceutical giant aims to hire another 50 people by the end of this year to work on a new platform dedicated to harnessing data and AI insights in drug discovery.
The French pharma paid $500 million upfront, with up to $1 billion in future milestone payments, to co-develop and co-commercialize Teva’s Phase II anti-TL1A antibody for inflammatory bowel disease.