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
Genmab announced Wednesday it is buying ProfoundBio and its pipeline of next-generation antibody-drug conjugates being developed for gynecologic cancers and other solid tumors.
With second-generation antibody-drug conjugates, Eli Lilly, Daiichi Sankyo and others look to reduce toxicity and improve the magnitude and duration of response.
The new Cambridge, Mass.–based facility is about 460,000 square feet. Labs occupy nearly 50% of the space.
Read the latest overview of people coming and going from executive positions at biopharma companies that BioSpace covers.
FDA
Plus, another big buy points to strength of CDMO market and a new treatment for pulmonary arterial hypertension
Under the agreement, Ipsen nabs exclusive global rights for development and commercialization of Sutro Biopharma’s STRO-003, an antibody-drug conjugate which is completing the final stages of preclinical development.
The biotech’s personalized neoantigen vaccine for colorectal cancer did not demonstrate a molecular response difference from the control arm. Gritstone blames trial protocol and plans for a Phase III study.
Roivant has chalked up a mid-stage victory for its Pfizer-partnered dual TYK2/JAK1 inhibitor, setting it up to start a Phase III trial in non-anterior non-infectious uveitis this year.
Verve Therapeutics is pausing enrollment in the Phase Ib Heart-1 study for its gene editor VERVE-101 after a patient developed grade 3 laboratory abnormalities, the company announced Tuesday.
Following promising Phase IIa data, Vertex Pharmaceuticals will now evaluate its oral drug candidate inaxaplin in a late-stage study of APOL-1 mediated kidney disease.