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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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Vaccinex announced positive interim response data in a Phase Ib study assessing pepinemab in combination with Merck’s vaunted checkpoint inhibitor, Keytruda.
The FDA approved Kimmtrak for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma (mUM).
The FDA placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine due to concerns of unexpected adverse events.
Much has been made about the side effects of the COVID-19 vaccines, but a new study found a startlingly high number of adverse events associated with people who received placebos in clinical trials.
The U.S. Supreme Court blocked the mandate earlier this month, stating that OSHA had overstepped its authority.
The company’s focus is to find somebody with considerable pharmaceutical industry experience to help advance regulatory and commercialization initiatives for leronlimab.
The amount will be used to enhance research and development efforts for KYV-101 that has a strong potential to treat different types of autoimmune illnesses.
In addition to the induction of both mucosal and systemic immunity, advantages of an intranasal approach include the lack of needles, low cost and thermostability under normal refrigeration temperature.
Leyden Labs secured $140 million in a Series B financing round. Combined with $40 million from a Series A round in March 2021, the company has significant funding to advance its portfolio of candidates.
Biotech companies are partnering with other biotech companies to combine their cutting-edge technology platforms in hopes of opening up new avenues for drug development.