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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.
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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.
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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.
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FDA
Thursday, a committee of advisors for the CDC voted unanimously for children and teens, ages six to 17 to receive Moderna’s COVID-19 vaccine.
CVS Health has seen about 40% patient diversity in the work it has done so far, Josh Rose, VP and head of decentralized clinical trials, site solutions and strategy told BioSpace.
Pfizer inked an Equity Subscription Agreement with France-based Valneva. They also updated their Collaboration and License deal for a Lyme disease vaccine that was announced in April.
Extension data from the Phase II TOPAZ trial showed that apitegromab yielded sustained and continued benefits in non-ambulatory patients with types 2 and 3 spinal muscular atrophy (SMA).
The FDA’s decision is based on positive results from two induction and one maintenance clinical study of AbbVie’s Skyrizi for Crohn’s disease.
BioSpace spoke with Janssen’s Fiona Elwood about the company’s myasthenia gravis candidate nipocalimab, which is currently recruiting for two Phase III trials.
Olema president and CEO Sean Bohen spoke with BioSpace about why he believes his company’s approach with a SERD and ER antagonist can successfully treat an advanced form of breast cancer.
An FDA advisory committee voted against Acadia Pharmaceutical’s supplemental New Drug Application of Nuplazid tablets for the treatment of Alzheimer’s-related psychosis.
Pharmaceutical giant Merck is exploring a possible purchase of biotech company Seagen, according to The Wall Street Journal.
VBI Vaccines and Hepion Pharmaceuticals have received Orphan Drug Designations from the U.S. Food and Drug Administration for their experimental cancer drugs.