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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.
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After the company’s investigational eye therapy recently failed two late-stage studies, Kodiak Sciences’ Chief Medical Officer and Chief Development Officer Jason Ehrlich has resigned from his roles.
The companies contend that their updated COVID-19 vaccines for the fall vaccination season can elicit strong immune responses against the virus’ currently dominant and emerging subvariants.
The company disclosed Thursday in a second-quarter report that it will continue advancing its chronic refractory gout treatment but is suspending further investments in its pipeline.
The German company on Thursday said it is launching three late-stage studies of its obesity drug candidate after the injectable showed up to 19% weight loss after 46 weeks in a mid-stage trial.
Some experts question the value of recently issued FDA guidance that aims to address gaps in the quality of unapproved laboratory tests for cancer.
After two prior setbacks, the regulator has finally approved Ipsen’s palovarotene to treat fibrodysplasia ossificans progressiva. It’s the first treatment for the ultra-rare bone disease.
Mifepristone’s legal saga continues as the U.S. 5th Circuit Court of Appeals ruled for steep restrictions on the drug’s access, though its effectivity is pending the Supreme Court’s review.
The company’s first-in-class small molecule imipridone, ONC201, showed strong efficacy results in two early-stage clinical trials of 71 pediatric patients with H3K27M-mutant diffuse midline gliomas.
The clinical trial testing Seagen’s tyrosine kinase inhibitor Tukysa, in combination with Genentech’s Kadcyla, met the primary endpoint of progression-free survival in HER-2 breast cancer patients.
The regulator informed bluebird bio that it will not convene an advisory committee meeting to discuss the company’s application for the gene therapy being developed for sickle cell disease.