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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
Ipsen will seek a new approval for Onivyde as a treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) after posting positive Phase III progression survival data.
The FDA deemed AstraZeneca’s PT027 to have a favorable risk-benefit profile for treating asthma in patients aged 18 or older but was less keen on supporting the drug in younger populations.
The FDA greenlit Libtayo plus chemotherapy to treat patients with advanced NSCLC irrespective of EGFR, ALK or ROS1 aberrations. It is the drug’s second approval in this space.
Adaptimmune has had a manic Tuesday, touting improved efficacy numbers for its T-cell candidate while also dealing with economic repercussions of its terminated partnership with GSK.
GSK is planning a Phase III trial evaluating bepirovirsen as a potential functional cure for chronic hepatitis B infection, despite the most recently released data appearing less robust than the interim analyses.
Sanofi entered into a partnership with Insilico Medicine to develop drugs for up to six targets. The deal is worth a potential $1.2 billion.
Juvena Therapeutics pulled in $41 million in Series A financing to advance research into the therapeutic potential of secreted proteins to target chronic and age-related diseases.
Researchers from the University of Washington have developed an investigational vaccine that can safely elicit an immune response against the HER2 protein, a key marker in breast cancer.
A request for additional data may cause a 3-month delay for potential approval of BioMarin Pharmaceutical’s hemophilia A gene therapy.
Sanofi inked a research collaboration and license agreement with Stockholm, Sweden-based Salipro Biotech to develop therapeutic antibodies or small molecules that target membrane proteins.