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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
Novartis believes Gyroscope’s investigational Phase II gene therapy for geographic atrophy has the potential to become the first therapy that demonstrates sustained efficacy for GA patients.
Ten studies are halted completely. Oral formulations of the drug will continue. Gilead stated that it is confident about the future of the drug’s potential and is working to resolve the vial quality problem.
Pioneers of synthetic biology have rallied together under the development of Senti Biosciences Inc, co-founded and led by Timothy Lu, associate professor of biological engineering, electrical engineering, and computer science at the Massachusetts Institute of Technology.
Amgen said the expansion would bring 150 construction jobs to the area.
Under the terms of the deal, Sanofi is paying Amunix $1 billion up front and up to $225 million in various development milestone payments.
In the last week, Omicron is credited for 73% of new COVID-19 infections and is accounted for 12.6% of positive cases, making it the most rapidly spreading variant the country has seen yet.
Pfizer has paused screening and dosing of a Phase Ib study of its experimental gene therapy treatment for Duchenne muscular dystrophy following the unexpected death of a patient.
The government charged Chicago-based Daniel V.T. Catenacci, a medical school professor who served as the lead investigator of the company’s cancer drug bemarituzumab.
After last week’s avalanche of clinical trial news associated with the American Society of Hematology Annual Meeting, there are far fewer announcements, but some companies are getting their news out ahead of the holidays.
ViiV Healthcare announced that the FDA approved Apretude, a long-acting injectable pre-exposure prophylactic option to reduce the risk of sexually acquired HIV-1.