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
Three IPO aspirants have stepped up at the start of the new year: CinCor Pharma, Amylyx and Applied UV
This California biotech just bagged another partner for its endeavor to cure autoimmune disease with cell therapy.
Data from pre-clinical studies show that OV350 may be developed to treat multiple types of epilepsy and other CNS conditions, including neurodevelopmental diseases.
Today, the FDA approved two new drug applications. One is for Spero’s tebipenem HBr oral tablets and the second is CStone’s IND application for CS5001.
Applied Therapeutics said it is holding off on a New Drug Application after discussions with the FDA, which appears to require additional clinical data.
Just as 2021 was wrapping up, the U.S. FDA had some end-of-year activity. Here’s a look.
Novavax vaccine’s emergency use authorization application has been submitted to FDA recently. Novavax is hoping to bring it to the Finish Line in 2022.
Right now, Kidd’s focus is on ensuring the company is ready for late-stage development and commercialization activities.
From the continuing fight against COVID-19 to new companies emerging in exciting therapeutic areas to the people who mattered most, here’s a look at just some of the biggest successes, most dramatic flops – and a few that fall somewhere in between.
Teva Pharmaceuticals will appeal a potential $1.5 billion judgment against the company in the state of New York for its alleged role in the opioid epidemic.