News
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
With the appointment of new CEOs, CMOs and CSOs, biopharma and life sciences organizations shuffled their leadership positions as Q3 comes to a close.
AbbVie is buying DJS Antibodies for $225 million in cash to gain access to the British company’s potential fibrotic diseases drug and antibody discovery program.
Erasca announced that it was expanding its existing partnership with Pfizer to assess its ERAS-007 in combination with the Big Pharma’s Ibrance.
Roche and Austria-based Hookipa Pharma tied up a licensing and research and development collaboration valued at more than $950 million focused on KRAS-mutated cancers.
After the Data Monitoring Committee reviewed the case based on protocol modifications implemented earlier this year, it was determined that enrollment in the trial and dosing may continue.
BMS’s blockbuster checkpoint inhibitor Opdivo hit the primary endpoint in the Phase III CheckMate -76K trial for a particularly intractable form of melanoma.
Kyverna Therapeutics filed its first IND application this week to test the efficacy and tolerability of KYV-101, a CAR-T therapy for lupus nephritis.
The FDA’s Obstetrics Reproductive and Urologic Drugs Advisory Committee voted nearly unanimously to withdraw the approval of Covis’ preterm birth drug Makena.
While worthy advances have recently been made in sickle cell disease, companies such as Graphite Bio, bluebird bio, Vertex Pharmaceuticals and Editas Medicine have loftier ambitions.
Massachusetts-based PIC Therapeutics has closed a $35 million Series A financing round centered around the advancement of its lead asset, a novel therapeutic for advanced metastatic breast cancer.