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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
U.S. President Joe Biden nominated Arati Prabhakar, Ph.D., to be his science advisor. If confirmed by the Senate, Prabhakar will become the first woman, first person of color and the first immigrant to hold the position.
Precision BioSciences and Novartis are teaming up to develop a potential cure for hemoglobinopathies such as sickle cell disease and beta-thalassemia.
Athira Pharma is putting a positive spin on its topline data from a Phase II trial of fosgonimeton, emphasizing positive subgroup analysis, but it missed the primary endpoint.
The bill would curb the pricing of insulin by capping monthly co-pays for diabetics who use both commercial insurance plans, as well as the government-backed Medicare.
FDA
On Wednesday, the FDA approved Merck’s pneumococcal 15-valent conjugate vaccine for children 6 weeks through 17 years of age.
Galapagos announced that it had acquired CellPoint and AboundBio in an all-cash transaction, greatly expanding its drug portfolio.
Novartis’ win in the patent dispute over its drug, Gilenya, was short-lived after a U.S. appeals court reversed its 2020 ruling vs. HEC Pharm’s attempt to create a generic version.
TC BioPharm is developing a new approach to chimeric antibody receptor (CAR) T-cell therapies with the potential to eliminate off-target effects, and possibly help more patients.
Decentralized clinical trials may cost more upfront, but can have huge returns on the back end, according to speakers at Informa Connect’s Decentralized Clinical Trials meeting.
9 Meters Biopharma is discontinuing a Phase III clinical trial for larazotide, a treatment for celiac disease as interim results were not statistically significant.