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In this episode of Denatured, you’ll hear from Jason Jones, head of global business development at Cellular Origins and Alexander Seyf, founder & CEO of Autolomous. They discuss how the push to scale cell and gene therapy manufacturing is accelerating interest in automation, digitization, robotics and deeper collaboration across the ecosystem.
FEATURED STORIES
As Daré Biosciences approaches a pivotal year with a key product launch ahead, the company kicked off an open public offering, providing a chance for individuals to get involved for as little as $250.
The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.
FDA
While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external controls—the application of this flexibility appears to be inconsistent. One former regulator says the situation is more nuanced.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
As Big Pharma companies consider foregoing European drug launches to avoid reducing drug prices in the U.S. in alignment with Trump’s Most Favored Nation policy, patients will suffer.
THE LATEST
The arrangement will boost AstraZeneca’s cell therapy portfolio as the pharma targets $80 billion in revenue by 2030.
The star of the acquisition, anti-IgE antibody ozureprubart, is being tested as a prophylactic treatment for food allergies, potentially setting up a competition for GSK with Roche’s Xolair.
The companies have an expansive clinical program for the mRNA neoantigen therapy intismeran autogene in combination with immuno-oncology heavyweight Keytruda.
BioSpace has revealed its new 2026 Hotbed Maps, showcasing seven regional life sciences hot spots.
The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies including Novo Nordisk see hurdles to implementing the changes.
Henry Gosebruch, who has $3.5 billion in capital to deploy, is thinking broad as he steers the decades-old biotech out of years of turmoil. 
In this bonus episode, BioSpace’s Vice President of Marketing ⁠Chantal Dresner⁠ and Careers Editor ⁠Angela Gabriel⁠ take a look at Q4 job market performance and what it signals for 2026.
IPO
Two more biopharma companies—the hair-growth specialist Veradermics and cancer-focused Eikon Therapeutics—have announced their IPOs this year. Meanwhile, Aktis Oncology began trading publicly earlier this month.
Despite the late-stage miss, analysts maintained confidence in the Epkinly program, with Truist Securities saying the result “doesn’t waver our optimism” regarding the bispecific antibody’s ongoing frontline trial.
Despite ushering in the current GLP-1 era, Novo Nordisk has fallen behind its chief rival Eli Lilly, which has exceeded the Danish pharma in terms of sales.