News
In this episode of Denatured, you’ll hear from Jack Crawford, CEO of Demeetra, and Magnus Gustavsson, chief commercial officer at NorthX Biologics. We unpack the evolution of cell line development — CHO cells, targeted integration, transposases and the collaboration models speeding biologics from sequence to GMP.
FEATURED STORIES
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
Austin, Texas-based Aeglea Biotherapeutics reported what initially appears to be positive outcomes for its Phase III PEACE trial of pegzilarginase in Arginase 1 Deficiency (ARG1-D).
An investigational drug for Dravet syndrome is showing promise in treating the progressive form of genetic epilepsy.
The latest updates from Mesoblast Limited’s Phase III trial on rexlemestrocel-L show that the drug provides the highest benefit when used in patients with certain types of chronic heart failure.
The approval of Keytruda also now includes stage III melanoma following complete resection for pediatric patients 12 years and up.
A major factor behind the success of the smallpox eradication campaign was political commitment and leadership.
The U.S. Food and Drug Administration is wrapping up 2021 with a fairly busy schedule for the month of December. Here’s a look at the first half of the month.
This afternoon, the U.S. Food and Drug Administration expanded the Emergency Use Authorization for Eli Lilly’s monoclonal antibody treatment combination of bamlanivimab and etesevimab.
After Sobi agreed to be acquired by Advent International and GIC Special Investments, the deal has fallen through after AstraZeneca withheld its 8% stake from the buyout offer.
Two years into the COVID-19 pandemic, countries are reporting the fourth wave of rising cases, driven mainly by the Delta variant, although Omicron has everybody concerned. Here’s a look.
Researchers from Harvard University and the U.S. Department of Veterans Affairs (VA) found that the Moderna mRNA vaccine was slightly better than the Pfizer-BioNTech vaccine.