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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.
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.
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Read on to learn about the different nursing positions available in the biopharmaceutical industry, as well as the skills and qualifications you need to be a successful biopharma nurse.
The result will be two independent, publicly traded companies: Labcorp and The Clinical Development Business offering Phase I-IV clinical trial management and technology to the biopharma industry.
FDA
FDA has approved GSK’s Benlysta (belimumab), making it the first biologic treatment for children ages 5 to 17 with lupus nephritis.
Eisai Inc. has appointed Thomas D. Fagan Jr. as VP for the U.S. Alzheimer’s Disease Commercial unit, which will be instrumental in growing the parent firms operations in the US.
The DESTINY-Breast04 trial introduces a new option for breast cancer diagnosis – HER2-low. The trial data received a standing ovation from thousands of oncologists at this year’s ASCO meeting.
The probe will be led by investigators experienced in determining whether or not entities have defrauded consumers, investors or government agencies.
SARS-CoV-2 typically enters the body via the nose or mouth. Because of this, many think a nasal spray vaccine would do a better job of preventing COVID-19 infection and cutting transmission than an injection.
On Wednesday, Swiss women’s health company ObsEva announced that it is dropping linzagolix, its leading candidate for uterine fibroids.
Only weeks after announcing a new chief executive officer and chief medical officer, Editas Medicine reported promising early data for its Phase I/II RUBY trial of EDIT-301 for severe sickle cell disease (SCD).
Pfizer and BioNTech initiated a Phase II trial of an enhanced COVID-19 vaccine while fending off lawsuits against CureVac and Alnylam over their technology.