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
Not surprisingly, there’s still plenty of interesting research coming out about COVID-19, but the end of 2021 also provided exciting science in other areas. Here’s a look.
Collegium reached a $2.75 million agreement with a law firm representing 27 U.S. cities, counties and subdivisions related to the opioid crisis and the company’s sale of Xtampza.
The decision to allow the release of Adbry follows positive results from the Phase III ECZTRA trials, which covered almost 2,000 patients living with moderate to severe atopic dermatitis.
BridgeBio Pharma reported topline data from Part A (Month 12) of its Phase III study of acoramidis for symptomatic transthyretin amyloid cardiomyopathy. The drug failed the study arm.
The company was assessing mavrilimumab as a potential therapeutic for COVID-19-related acute respiratory syndrome.
When 2022 rolls around in a little more than a week, some Genentech employees will begin the new year in search of a new job.
The FDA has greenlit Merck and Ridgeback’s molnupiravir under EUA to treat mild to moderate COVID-19 infections in adults at high risk of progression to severe disease.
Studies found that AstraZeneca’s EVUSHELD was still effective against the Omicron variant. EVUSHELD is a long-acting antibody combination made up of tixagevimab and cilgavimab.
Janssen Pharmaceutical says goodbye to San Francisco’s Theravance Biopharma after a disappointing performance from a drug the two companies were developing together.
The latest approvals mark the first time a biologic has been approved for ERA. Cosentyx is also the only biologic approved in the United States for both ERA and PsA in pediatric patients.