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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.
THE LATEST
The EMA’s safety committee has announced that they are reviewing reports of menstrual disorders after people received COVID-19 vaccinations from Pfizer-BioNTech and Moderna.
Shares of Cassava Sciences are up more than 5% in premarket trading after the FDA denied a Citizen Petition filed last year to suspend the company’s Alzheimer’s clinical trials.
New research published this week gives a greater understanding of why the CDC warned of an increased risk of stillbirth for women infected by SARS-CoV-2 during pregnancy in November.
New two-year data from Phase III studies of Susvimo and Vabysmo reinforce the two drugs’ potential to improve the quality of life of patients diagnosed with DME and nAMD.
On Feb. 15, the FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to discuss an amended EUA for the Pfizer-BioNTech vaccine in the under 5 age group.
President Biden called for the U.S. Senate to approve his Build Back Better legislation to reduce the cost of prescription drugs provided through Medicare.
CMS issued a draft decision for Biogen’s Alzheimer’s drug and said it would only cover the cost of Aduhelm and any required scans “if they are enrolled in qualifying clinical trials.”
The promising results from the pediatric expansion are what fuels Novavax’s next move to apply for regulatory approval for the 12-to-17-year age group by the first quarter of 2022.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended 14-1 that the two companies conduct a trial applicable to the U.S. population.
The speakers extolled the benefits of telehealth while noting the challenges posed by a lack of high-speed Internet in some parts of the country.