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 sees Exelixis, BioInvent, ImmunoGen and Oxford BioTherapeutics coming together to develop antibody-based therapies for cancer.
Biogen has terminated its asset purchase agreement with Karyopharm Therapeutics, putting a halt to the development of KPT-350 (BIIB100), which was being evaluated as a treatment for ALS.
An FDA advisory committee voted Wednesday to recommend both the Pfizer-BioNTech and Moderna COVID-19 vaccines for children as young as six months old.
Dr. Soon-Shiong and ImmunityBio are on the final leg of what they hope will be the FDA approval of their drug N-803 (anktiva) for the treatment of bladder cancer.
Clover dosed the first participants in a Phase III study of its COVID-19 booster shot, while Global Access Diagnostics, Orbit Discovery, Proximie and more provide business and pipeline updates.
Representation of women in biotech is nearing parity, but this is not reaching the executive level, where there is still stark disparity.
FDA
A recent study found that over a span of ten years, the FDA approved cancer drugs approximately eight months earlier than the same drugs were greenlit by the European Commission (EC).
Since 2020, the life sciences industry has worked to rebound from the COVID-19 pandemic. But one sector’s growth has far outpaced the others–the biotech industry.
Jazz Pharmaceuticals, Redx Pharma and Omega Therapeutics are pushing forward with their cancer treatments with Investigational New Drug approval and IND application submission.
Industry lobbyists urge Congress to approve a plan that will allow companies not yet generating revenue from their assets to sell NOL carryforwards to larger companies.