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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
The FDA presented briefing documents Monday outlining what it called “uncertainties” in the data presented by Veru regarding its COVID-19 antiviral. An advisory committee will meet Wednesday.
AbbVie’s investigational neurotoxin, designed to prevent postoperative atrial fibrillation, missed the primary endpoint in a Phase II trial, the company announced Monday.
Sensorium Therapeutics, which closed a $30 million Series A Tuesday, is embracing the complexity of neuropsychiatric diseases with nature-inspired psychoactive medicines.
Verve Therapeutics’ base editing program has been forced into a detour after the FDA placed a hold on its investigational new drug application. Beam has also posted its own regulatory update.
Biopharma’s efforts to conquer immunoglobulin A nephropathy were on full display at ASN’s Kidney Week as Ionis, Chinook and Vera all reported positive data.
Eye specialist Oyster Point Pharma announced is being acquired by Viatris Inc. after Oyster’s board of directors unanimously signed off on the deal, Oyster Point announced Monday.
GSKs Blenrep misses the mark in the Phase III DREAMM-3 trial for relapsed or refractory multiple myeloma (RRMM), possibly putting the drug’s continued approval at risk.
The only patient in an FDA-sanctioned clinical trial assessing a CRISPR-based therapy for a rare form of Duchenne muscular dystrophy has died, according to study sponsor Cure Rare Disease.
Eli Lilly’s and Boehringer’s Jardiance met its primary outcome in the Phase III EMPA-KIDNEY study, the largest and broadest SGLT2 inhibitor trial in chronic kidney disease.
Akebia Therapeutics has submitted a Formal Dispute Resolution Request with the FDA regarding the rejection of vadadustat in anemia due to chronic kidney disease.