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 data for Reproxalap, Aldeyra Therapeutics’ drug for treating allergic conjunctivitis and dry-eye disease, could potentially pave the way for an alternative to over-the-counter eye drops.
The stock deal aims to strengthen Coherus Biosciences’ position in the field of cancer therapeutics and expand its product portfolio.
The Bespoke Gene Therapy Consortium intends to bring AAV-based gene therapies to patients whose diseases are often ignored by commercial interests.
With Roche’s FDA approval on Thursday, both companies’ bispecific antibodies will hit the market this summer for relapsed or refractory diffuse large B-cell lymphoma.
In the latest HEALEY trial readout, Clene’s CNM-Au8 significantly reduced plasma neurofilament light chain levels in ALS patients, which could be a strong and reliable signal of its clinical benefit.
In a unanimous 21-0 vote, an FDA advisory committee recommended an updated monovalent formulation of the COVID-19 vaccine targeting the now-dominant XBB.1.5 subvariant.
After an FDA advisory committee unanimously recommended Leqembi’s full approval, questions linger around amyloid-related imaging abnormalities and a potentially cumbersome patient registry.
The FDA has four target action dates this week, including ones for Argenx’s subcutaneous efgartigimod in generalized myasthenia gravis and Sarepta’s gene therapy for Duchenne muscular dystrophy.
The pharma company alleges that BeiGene’s Brukinsa patent, issued on Tuesday, infringes on its patent for Imbruvica to treat patients with slow-growing blood cancer.
The Japanese biopharma is diving deeper into targeted protein degradation, paying $35 million upfront for access to Cullgen’s uSMITE platform.