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 bladder cancer-focused biotech is looking to be one of the first companies out of the gate with an initial public offering in 2024.
Regulatory authorities worldwide are tightening their monitoring mechanisms and launching their own investigations after reports of secondary malignancies potentially linked to chimeric antigen receptor T cell therapies.
Taiwanese contract development and manufacturing organization Bora will purchase Minnesota-based Upsher-Smith Laboratories, expanding operations into the U.S. for the first time.
The FDA’s Complete Response Letter identified problems with the drug candidate’s chemistry, manufacturing and controls, parent company Shin Nippon Biomedical Laboratories announced Thursday.
The Swiss pharma’s Phase III trial of ligelizumab in patients with peanut allergies has been terminated, according to a ClinicalTrials.gov update on Tuesday.
The San Diego-based startup, specializing in allogeneic engineered Treg and CAR-Treg cell therapies, plans to be in Phase I clinical trials in multiple indications in 2024.
The sweeping changes are meant to “reduce hierarchies” and “accelerate decision-making” as Bayer weathers several business crises and continues to suffer from the fallout of its disastrous Monsanto acquisition.
In a changing landscape, top companies are increasingly embracing remote work.
When combined with Tecentriq and chemotherapy, tiroagolumab increased median survival to 15.7 months compared to 11.1 months for patients with esophageal squamous cell carcinoma on chemo alone.
The team comes together to discuss the dominant themes of what was an incredibly busy week of events in San Francisco during JPM 2024.