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
With Monday’s FDA rejection of their long-acting glatiramer acetate formulation, Viatris and Mapi Pharma continue the biopharma industry’s recent losing streak in multiple sclerosis.
Early Phase IIb data from 66 patients showed Novartis’ BTK inhibitor remibrutinib has potential outside chronic spontaneous urticaria, leading to symptomatic relief in patients with hidradenitis suppurativa.
Fresh off its $259 million Series C funding round, Alumis unveiled mid-stage data Saturday for its TYK2 inhibitor ESK-001 demonstrating strong symptomatic improvement in moderate-to-severe plaque psoriasis.
Johnson & Johnson’s Protagonist-partnered oral psoriasis candidate was able to sustain its therapeutic benefit through one year, according to data presented on Saturday at the American Academy of Dermatology annual meeting.
Novo Nordisk’s blockbuster weight-loss drug Wegovy was approved on Friday by the FDA to reduce the risk of cardiovascular death, heart attack and stroke in adults who have cardiovascular disease and are obese or overweight.
In this deep dive, BioSpace examines what’s next for Leqembi, the true cost of anti-amyloid antibodies, and what other Alzheimer’s treatments are coming down the pipeline.
The approval, which Bristol Myers Squibb reported on Thursday, positions the company to compete with Astellas and Pfizer’s Padcev.
According to Fresenius Kabi, Tyenne is the first biosimilar to Genentech’s Acterma which has both IV and subcutaneous formulations approved by the FDA.
The company announced Thursday it terminated its BTK inhibitor evobrutinib for multiple sclerosis, which did not meet the primary endpoints in two late-stage trials.
MindMed’s stock price jumped over 50% Thursday as its LSD-based candidate for generalized anxiety disorder got a breakthrough therapy designation from the FDA.