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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
New real-world studies from Scotland and England shows that Omicron does not lead to as much hospitalization as Delta. This is consistent with the latest reports from South Africa that say Omicron causes milder disease.
The FDA has approved Novartis’ new drug for lowering bad cholesterol. Leqvio is the first and only siRNA treatment that can reduce low-density lipoprotein cholesterol.
PhaseBio’s move to suspend its Phase IIb trial of pemziviptadil is due to the effect of COVID-19 on manufacturing, associated drug supply, and the rate of enrollment in the study.
The U.S. Food and Drug Administration granted Emergency Use Authorization to Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets) for high-risk adults and pediatric patients 12 years and older to treat COVID-19.
With all eyes on a new year, life sciences companies and organizations are making last-minute appointments to strengthen their leadership teams and board with these Movers & Shakers.
Takeda hoped that its experimental therapy could become the first FDA-approved treatment for EoE. However, the FDA wants the company to initiate another clinical study with TAK-721.
The company aims to use the $100 million investment to support biotechnology firms involved in treating mental diseases and longevity projects.
The new Phase III study will include an enhanced version of the Viaskin Peanut patch, approximately 50% larger than the patch initially rejected by the FDA.
Allakos reported mixed results on two clinical trials, the Phase II ENIGMA 2 and Phase II/III KRYPTOS trials of lirentelimab.
Dr. Charles Lieber was convicted Tuesday by a federal jury after being found guilty of lying to the U.S. government about his questionable ties with the People’s Republic of China.