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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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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.
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Taysha said the data for TSHA-101 is the “first-ever to support the bicistronic vector approach in humans delivering both HEXA and HEXB genes in the endogenous ratio.”
Biogen is selling its nearly 50% stake in Samsung Bioepis for $2.3 billion. The move will provide Biogen with additional capital while preparing to cut additional costs through a rumored employee layoff.
The FDA had accepted the sBLA in September 2021 under priority review status.
Moderna invested heavily in mRNA technology to manufacture some 900 million doses of the COVID-19 vaccine. Now, the company has created an mRNA-based vaccine to prevent HIV.
The company initiated the use of splenic nerve simulation last month as part of a small clinical trial at the NHS Greater Glasgow & Clyde Health Board in Scotland.
Alzamend Neuro is looking to commence a Phase II multiple ascending dose study of lead compound, AL001, in Alzheimer’s disease during the second quarter of this year.
The studies are of the U2 combination Ukoniq (umbralisib) and ublituximab for chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL).
The FDA is calling the study a phase II trial and says the company must run a rodent genotoxicity study before it can continue.
Americans pay the highest drug prices in the world while importing drugs for lower prices from other countries has been locked down on a personal level and labeled as “unsafe.”
Pfizer hopes to step in to ensure that no trade secrets are disclosed when the regulatory agency begins to share that information.