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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.
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
Acer Therapeutics and Relief Therapeutics announced the FDA has denied their NDA for ACER-001 (sodium phenylbutyrate) for the treatment of urea cycle disorders.
Despite the refutation of research articles by Piero Anversa, they continue to serve as a basis for funding requests from scientists who hope to prove that the heart can regenerate cardiac muscle.
Mark Cuban Cost Plus Drug Company now boasts over 700 prescription generic drugs for a variety of conditions, ranging from acid reflux to dementia to autoimmune diseases like Rheumatoid Arthritis.
Three physicians filed a lawsuit against the FDA alleging the organization acted outside its authority and with their ability to practice medicine by discouraging the use of ivermectin to treat COVID-19.
The week began with positive updates in the vaccine development space against various infectious diseases from Emergent, Merck, Affinivax and Ocugen.
AstraZeneca and Ionis reported that their NEURO-TTRansform Phase III trial in hereditary transthyretin-mediated amyloid polyneuropathy hit its co-primary endpoints.
For years, PTC Therapeutics has attempted to win regulatory approval for its DMD drug, Translarna. Now, the company believes it has data that will support another filing for FDA approval.
Therorna brought in $42 million to advance its circular RNA platform, while Carbon Biosciences banked $38 million to develop therapies for genetic diseases, beginning with cystic fibrosis.
In the coming 12 months, Rain expects to have an interim readout for a Phase II study of its liposarcoma therapy, milademetan, and a pivotal readout for its Phase III trial of the same compound.
The government of France launched its Healthcare Innovation 2030 strategy that aims to turn the country into a European innovation leader within the next eight years.