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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.
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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.
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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.
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The expert group referred to as “Supermind” shared ideas on five areas over four-weeks last year. Here are some of the highlights.
Cellino is a closed loop cell therapy manufacturing company that aims to make stem cell-based regenerative therapies available to all eligible patients and researchers using cells in clinical research.
Shares of Mustang Bio have fallen more than 13% in premarket trading after announcing the FDA had placed a hold on the company’s Investigational New Drug application for its bubble boy gene therapy.
The Phase III MOMENTUM trial showed that momelotinib was able to meet its primary endpoint by week 24, specifically a TSS reduction of over 50% compared to the baseline figures.
As Omicron continues to dominate globally, research is coming in every day on this highly contagious variant of SARS-CoV-2.
Sixty-three percent of patients met the primary endpoint of a 2-point or greater improvement in disease severity without worsening of fibrosis.
The FDA cited data demonstrating that both treatments are not likely to be potent against omicron and should not be authorized for use in any U.S. state, territory, and jurisdiction for the time being.
The company submitted its application for AP-188 in early 2021, covering dosage details, formulation, and method of stroke rehabilitation.
BioSpace sat down with Niko Andre, M.D., Ph.D., global franchise head for hematology and immuno-oncology at AstraZeneca.
MaaT Pharma decided today to end the Phase Ib CIMON study for MaaT03, the company’s second drug candidate and first oral formulation in Phase 1b clinical trial, following positive interim engraftment data of the drug.