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
The future of Editas Medicine’s EDIT-101 will be determined later in November after a data readout is available. The data could inform the company whether there is a potential commercial path forward.
Surface Oncology announced it is pausing the development of its CD39-targeted antibody SRF617 and cutting around 20% of its workforce to focus on its lead anti-IL-27 program SRF388.
J.P. Morgan launched its new life science-focused private equity team, Life Sciences Private Capital, to support early- and growth stage biotech companies.
Verge Genomics dosed its first patient in a Phase I trial studying VRG50635, while Stealth Bio’s SBT-272 was granted Orphan Drug designation by the FDA.
Unity announced advances in diabetic macular edema via Phase II study results, potentially allowing its recipients to return to tasks of daily living, like driving.
Johnson & Johnson announced it was acquiring all outstanding shares of Abiomed for $16.6 billion to expand Abiomed’s cardiovascular technologies and increase patient access.
In a Phase III trial, Pfizer’s RSVpreF, a bivalent RSV vaccine, protected infants against severe medically attended lower respiratory tract illness when administered during the second or third trimester.
On Nov. 16, the FDA’s Cardiovascular and Renal Drug Advisory Committee will meet to discuss the relative merits of Ardelyx’s tenapanor in chronic kidney disease.
Monday, Actinium Pharmaceuticals released promising results Monday from a Phase III trial studying its lead radiotherapy candidate, Iomab-B, for patients with relapsed or refractory AML.
The implications of the Inflation Reduction Act of 2022 (IRA) are beginning to show as Alnylam drops the Stargardt indication for vutrisiran and Sanofi’s CEO reassures investors.