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
Researchers studied the behavior of protein cells in the brain and found a significant difference in those who have had dementia and those who have not, particularly in their ability to clean themselves.
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
In the CRL, the FDA indicated that the single registrational trial (106 Phase III) did not provide sufficient proof of efficacy to demonstrate benefit.
Research continues to reveal how COVID-19 affects different people with different health issues, both short-term and long-term.
With this new collaboration, Astellas will take advantage of Dynos’ next-gen AAV vectors to deliver its gene therapy.
The Phase III DISCREET study evaluated the efficacy of Otezla in adults who have been diagnosed with moderate to severe plaque psoriasis and genital psoriasis.
The approval was based on Phase II data from the PLEIADES study that showed patients treated with the combination therapy generated an overall response rate of 84.8%.
The radiopharmaceuticals being developed by Curie are composed of rationally designed conjugates in contrast to delicately chosen biological targets.
The FDA’s decision is based on positive results from two Phase III trials, the PROTECT and CONSTANT, on the drug’s efficacy.
The 12-month data showed that 50 mg of zuranolone was well-tolerated among adults with MDD.