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 FDA lifted the clinical hold on Dyne Therapeutics’ clinical study of DYNE-251 in Duchenne muscular dystrophy (DMD) patients amenable to skipping exon 51. A Phase I/II trial is expected by mid-year.
Even though the COVID-19 pandemic appears to be under control, it’s clear that it’s not over, with the rise of more subvariants. Read on for more details.
Following the Supreme Court’s decision to overturn Roe v. Wade, abortion rights activists are calling for the FDA to consider making abortion medication Mifeprex an over-the-counter option for patients.
The transaction, expected to close in the third quarter of this year, includes TeneoTwo’s proposed drug for relapsed and refractory B-cell non-Hodgkin lymphoma TNB-486.
Seagen announced positive data from its Phase II trial in colorectal cancer, and the FDA provided positive feedback supporting a Phase IIIb trial for ANeuroTech’s MDD drug.
The FDA lifted its clinical hold on Vertex Pharmaceuticals’ Phase I/II clinical trial of VX-880, a pancreatic islet cell replacement therapy for people with Type I Diabetes (TID).
BioSpace connected with Theodore Laetsch, M.D., lead investigator of the pediatric larotrectinib trial (SCOUT), to gain more insight into the drug, the trial and how patients’ lives are being affected.
During the past two years, life sciences companies have made a commitment to Diversity, Equity and Inclusion - but have they taken internal actions?
Quris has developed an alternative to testing on animal models, and each one is smaller than the head of a pin. It holds the potential to increase the currently terrible odds in drug development.
Otsuka and Lunbeck report positive Phase III results in agitation in Alzheimer’s, Acer’s vEDS program hits Phase III and BridgeBio’s primary hyperoxaluria type 1 program progresses.