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
FDA
Going through the most newsworthy stories of the year, BioSpace found trends more than one big story, topics that just kept rising again and again. Here’s a look.
Mergers and acquisitions are part of the lifeblood of the pharmaceutical industry, as companies flex their pocketbooks to acquire pipelines and talent to bolster and complement their own programs.
Nasal spray vaccine delivery for COVID-19 has been explored by multiple companies since the beginning of the pandemic.
Moderna has decided to drop the patent application to “allow more time for discussions with the NIH”, which will be aimed at an amicable resolution.
FDA
Shares of Coherus BioSciences are climbing in premarket trading after the company announced the FDA greenlit the company’s Humira biosimilar Yusimry.
As the spread of the Omicron variant of COVID-19 picks up speed, vaccine makers are rushing to test their shots against the new mutation, with mixed results.
Novartis announced it has licensed BeiGene’s ociperlimab, a late-stage TIGIT inhibitor, to bolster its immunotherapy pipeline.
FDA
On Monday, Intra-Cellular Therapies announced that the FDA has approved CAPLYTA to treat the deep depressive episodes of patients with bipolar I or II.
The year kicked off with a bang as multiple companies raced to a public listing.
The decision comes after the FDA granted the drug, Tezspire (tezepelumab), Priority Review status on positive results from the PATHFINDER clinical trial program.