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
Positive news continues for COVID-19 vaccine development and distribution, with Sanofi and GSK announcing the success of their candidate against the Omicron variant.
FDA releases new draft guidance that addresses Breakthrough Therapy designation and action plan for rare, neurodegenerative diseases.
A new report by PwC projects that the second half of this year will see a “flurry of deals activity across all areas of the sector.”
The Boston University School of Medicine has unraveled details about a known genetic component for the development of Alzheimer’s disease (AD): the APOE4 gene.
The life science industry is growing rapidly, and many companies have announced expansions and job creation. Still, others have been forced to cut costs and slash jobs. For that and more, continue reading.
With the submission of NDAs and BLAs, multiple companies are bidding for regulatory approval of drug candidates. BioSpace takes a look at several of the latest requests.
Biogen indicated it has terminated an observational study of its approved Alzheimer’s drug Aduhelm after only 29 people signed up for an expected enrollment of 6,000 patients.
Sarepta announced that the FDA has put the Phase II trial for its SRP-5051 (vesleteplirsen) for the treatment of patients with DMD on clinical hold following a serious safety signal.
The Roche Accelerator is designed to help companies bridge the gap between idea and proof-of-concept. It is one of several incubators recently founded by Western companies.
AbbVie has redeemed a Rare Pediatric Disease Priority Review Voucher for Rinvoq (upadactinib), following its FDA approval for adults with moderately to severely active ulcerative colitis in March.