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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
AVROBIO is planning a Phase II/III registrational trial for its Gaucher Disease Type 3 (GD3) gene therapy candidate, AVR-RD-02, in 2023.
FDA
In the heated race for a new respiratory syncytial virus vaccine for older adults, Pfizer gained ground on GSK after winning priority review designation for its vaccine candidate.
Neurocrine’s NBI-827104 failed to meet the primary endpoint in a Phase II study for epileptic encephalopathy with continuous spike-and-wave during sleep, the company announced Tuesday.
Eli Lilly and Boehringer Ingelheim declared another victory Wednesday for Jardiance – this one for children and adolescents with Type 2 Diabetes.
Findings from the Phase II ARTEMIS-UC and Phase IIa APOLLO-CD trials show that Prometheus’ PRA023 is potentially safe and effective for treating ulcerative colitis and Crohn’s disease.
Novartis announced that its Kisqali with endocrine therapy offered almost a year of progression-free survival (PFS) for an aggressive form of HER+/HER2- metastatic breast cancer.
Apogee Therapeutics sprang onto the immunology/inflammatory scene Wednesday heavy on capital but light on salient details of the pipeline.
Karuna Therapeutics appointed Bill Meury as its new president and chief executive officer, succeeding its current head, Steve Paul.
Editas Medicine released positive proof of concept data Tuesday morning from the first patients dosed with its experimental CRISPR-based gene therapy for sickle cell disease.
Entact Bio launched with $81 million Tuesday to advance its protein enhancement platform.