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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
While Biocon intends to address the CRL, the company has not established a timeline for the resubmission of data and hopes that the FDA will rapidly review the BLA when it does submit the data.
The approval was based on data from a broad clinical program of 1,854 adults with insomnia conducted at more than 160 clinical sites in 18 countries.
The U.S. averages more than 700,000 new COVID-19 cases per day. As of Saturday, there were 4.91M cases, more cases in seven days than in April, May, June, and July 2021 combined.
Around 40% of Pfizer’s portfolio was realized through partnerships, and Monday, the pharma giant announced three more collaborative deals.
The results over the two-year evaluation period for its Phase III GENEr8-1 trial showed consistent clinical benefit from using valoctocogene roxaparvovec.
The planned acquisition will give Takeda full access to Adaptate’s antibody-based γδ T cell engager platform, which includes both pre-clinical and discovery assets.
Bayer and Mammoth Biosciences forged a strategic collaboration potentially valued at more than $1 billion. The partnership grants Bayer access to Mammoth’s CRISPR technology to develop in vivo gene-editing therapies.
The emerging generation of precision gene therapies addresses what has been one of this genre’s greatest challenges to date: the risk of unintended consequences.
BioSpace sat down with 12 executives who shared their thoughts on the coming year and decade.
Biopharma companies are building momentum to carry them through the bulk of 2022. BioSpace takes a look at some of the recent announcements.