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
Following a nearly decade-long effort, Delcath Systems finally won the FDA’s greenlight for its Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma.
Following injection site reactions in a Phase I study, the company is developing a new formulation for its Friedreich’s ataxia candidate setting the asset’s clinical progress back significantly.
The company is ending its investigational drug GB0139’s run in idiopathic pulmonary fibrosis after the small-molecule inhibitor failed to slow lung function decline in a Phase IIb study.
Following its Scorpion Capital controversy in March, Harmony Biosciences is seeking to deepen its pipeline with an acquisition of Zynerba Pharmaceuticals’ cannabinoid therapies for neuropsychiatric disorders.
On the heels of J&J’s Talvey, Pfizer’s bispecific antibody Elrexfio has secured an accelerated approval as another off-the-shelf treatment option for patients with relapsed or refractory multiple myeloma.
The legal complaint, filed with the Scripps Research Institute, alleges that Dexcel Pharma Technologies’ plan to sell a generic version of Pfizer’s Vyndamax (tafamidis) infringes on three patents.
Valneva’s chikungunya vaccine candidate will have to wait three more months for a decision from the regulator, potentially giving rival Bavarian Nordic additional time to catch up.
J&J’s Janssen Pharmaceutical got the FDA’s greenlight Friday for its PARP inhibitor Akeega, which is now authorized to treat BRCA-mutated metastatic castration-resistant prostate cancer.
The clinical-stage company joins several others in the anti-CD47 space which have dropped studies amid poor results, including Gilead Sciences’ decision late last month to stop a Phase III trial.
Week in Review: Novo Nordisk Riding High, Novavax in the Black (For Now), Nektar Sues Lilly and More
Novo’s weight-loss drug Wegovy improves cardiovascular outcomes, Novavax posts surprise Q2 profit, while Nektar Therapeutics files lawsuit against Eli Lilly for misconduct in drug development deal.