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
The FDA approved the latest indication for Rinvoq (upadacitinib) based on data from two Phase III studies, SELECT-PsA 1 and SELECT-PsA 2.
Although it’s not yet clear how dangerous the Omicron variant of COVID-19 actually is, it clearly is very infectious and rates are rising in the U.S. and around the world.
These results set Lilly up well to submit a Biologics License Application (BLA) in the first half of 2022.
The latest warning letter asks Medtronic to update its systems and procedures in order to deliver safe and high-quality devices to consumers.
The FDA’s approval of Xeljanz is based on Pfizer’s Phase III multicenter, double-blind, placebo-controlled study. Here are more details about the study.
During a season of giving, investors were extra generous to these biotech companies this week.
The JP Morgan Health Care Conference is held annually in January, and usually kicks off the biggest biopharma business news stories of the year. But in 2022, it’ll do so without at least three big names in the industry.
Bristol Myers Squibb is dropping $920 million to acquire the exclusive global rights of Immatics’ experimental cancer drug program, the companies announced Tuesday morning.
Texas’ top law enforcement official is taking aim at two drug companies over what he alleges is the promotion of hormone blockers for children experiencing gender dysphoria.
The FDA said that it is not authorizing molnupiravir’s use during pregnancy as there are hardly any clinical scenarios where the benefits appear to outweigh the risks.