News
As bispecifics, ADCs, protein degraders, and AI-designed mini-proteins move into the clinic, discovery teams face a new bottleneck: engineering and producing molecules whose complexity challenges conventional workflows.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
The drugmaker’s dominance of the obesity market is fueling predictions that years of growth lie ahead.
Job Trends
With layoffs happening at biopharma companies of all sizes, some may wonder which jobs are safest. Talent acquisition experts spoke to BioSpace about the areas and roles they recommend to biotech and pharma professionals hoping to avoid staff cuts.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
When talking to some of the most impressive women in biopharma, the conversation inevitably turned to what these women wanted other entrepreneurs to know. Here’s the best of the best of that advice.
THE LATEST
Tecvayli plus Darzalex led to an 83% boost to progression-free survival versus the current standard therapy in relapsed or refractory multiple myeloma, results analysts at Guggenheim Securities called “remarkable.”
Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several FDA initiatives seeking to shorten the drug review process.
Alicia Jackson formerly served as deputy director of the Biological Technologies Office at the Defense Advanced Research Projects Agency.
Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.
Johnson & Johnson will discontinue the Phase II Auτonomy study of posdinemab after a scheduled review found the anti-tau antibody failed to slow clinical decline in patients with early Alzheimer’s disease.
Analysts agree that the failure of Novo Nordisk’s semaglutide to reduce Alzheimer’s disease progression removes a “modest” or “perceived” overhang on Biogen and the anti-amyloid antibody class in general, clearing the way for increased uptake of Leqembi and Eli Lilly’s Kisunla.
“We felt we had a responsibility to explore semaglutide’s potential, despite a low likelihood of success,” Martin Holst Lange, Novo’s R&D chief, said on Monday.
NervGen will meet with the FDA early next year to align on a regulatory path forward for NVG-291 in chronic spinal cord injury.
Asundexian’s Phase III win could also bode well for Bristol Myers Squibb, which is also developing a Factor XIa inhibitor called milvexian for stroke prevention, analysts said.
A source familiar with the matter said the White House initially requested the resignation of Sanjula Jain-Nagpal, a policy and research official at the FDA.