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
This week’s Movers & Shakers includes Tessa and Adial bringing in new CEOs, while other companies strengthened their regulatory and medical teams with key appointments
Erytech Pharma is abandoning plans to submit a Biologics License Application to the FDA for Graspa in hypersensitive acute lymphoblastic leukemia.
AstraZeneca announced a series of wins in Japan with regulatory approvals for Tagrisso, Ultomiris and Lynparza, to treat non-small cell lung cancer, myasthenia gravis and breast cancer, respectively.
BioMarin’s Roctavian was granted conditional authorization in the European Union, making it the first gene therapy approved for severe hemophilia A. Now, the company is shooting for U.S. approval.
NIH researchers found that symptomatic herpes viruses were associated with neurological symptoms, but there was no evidence that herpes viruses are linked to Alzheimer’s disease.
Bay Area-based 3T Biosciences launched Thursday with a technology platform its leadership team believes can change the future of treatment for solid tumors and immune-mediated diseases.
Novartis announced Wednesday it is temporarily halting dosing in its ongoing Phase IIb VIBRANT-HD trial of branaplam in Huntington’s disease.
Sonoma Bio announced its plans to erect an 83,000-square-foot operations facility in Seattle, while Thermo Fisher opened a new viral vector manufacturing plant in Massachusetts.
Anthony Quinn has stepped down from his role as chief executive officer and transitioned to an advisory role. Jim Kastenmayer, general counsel, will assume the post on an interim basis.
In an interview with Reuters, AstraZeneca CEO Pascal Soriot said Tuesday that he isn’t sure if the company will continue developing vaccines. He also hinted at potential M&A action.