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
Merck initiated a tender offer Monday to buy all outstanding shares of Imago Biosciences. This follows the November announcement of the buyout.
Affimed will not seek accelerated approval for AFM13 as a monotherapy in advanced-stage relapsed/refractory peripheral T cell lymphoma.
Amgen confirmed Monday it will acquire rare disease giant Horizon Therapeutics for $26.4 billion.
Wall Street is no longer enamored with NASH drug developers.
Combinations including Ibrutinib stood out in hard-to-treat hematological cancers at the 64th American Society of Hematology (ASH) annual meeting.
As 2022 comes to its conclusion, the FDA has a handful of Prescription Drug User Fee Amendments still to wrap up. Here’s a look at that and more.
UCB shared positive top-line results Friday from two Phase III studies of bimekizumab for adults with moderate to severe hidradenitis suppurativa.
Autolus Therapeutics is calling the Phase II FELIX trial, assessing its next-generation CAR-T therapy obe-cel for leukemia, a win after an interim analysis revealed an overall remission rate of 70%.
A combination of Exelixis’ cabozantinib and Roche’s Tecentriq missed the primary endpoint of overall survival in a Phase III study.
ImmunoGen entered into a clinical collaboration deal with Gilead Sciences Friday to evaluate the safety and efficacy of two drugs that, when used in concert, have the potential to treat AML.