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
Myovant Sciences formed a special committee of independent directors to assess Sumitovant Biopharma’s offer after Sumitovant announced plans to acquire the company.
AstraZeneca is acquiring LogicBio Therapeutics in a deal worth $68 million. The deal bolsters AstraZeneca’s efforts to braoden its portfolio in genomics and rare diseases.
The FDA’s approval of Amylyx’s Relyvrio has ignited the growing momentum in the ALS space. BioSpace spoke with Amylyx co-CEOs Justin Klee and Josh Cohen and leading ALS researcher Dr. Merit Cudkowicz.
Theratechnologies’ Trogarzo for HIV, Alnylam’s Lumasiran for advanced primary hyperoxaluria, scPharmaceuticals’ Furoscix for heart failure and more. Here’s a look at the FDA’s October calendar.
Biopharma companies are expanding beyond the traditional confines of Massachusetts and California with hubs forming – most notably – in the South and Southeast.
The FDA had a busy week, approving drugs, greenlighting clinical trials and other regulatory activities for Immuneering, Amylyx, Sarepta, Sanofi, and Regeneron and more.
Shares of Rocket Pharmaceuticals jumped Friday morning after the company announced positive clinical updates from a Phase I study of patients diagnosed with Danon disease.
In its ongoing battle against counterfeit drug rings, Gilead Sciences announced it has identified two “kingpins” behind the scheme to sell illegitimate HIV medications.
The HHS Office of Inspector General found that of 278 accelerated approvals between 1992 and 2021, 104 had incomplete confirmatory trials, according to a report issued Thursday.
As it gears up to launch several new products, Moderna has created a new leadership role and onboarded an industry veteran.