Artificial intelligence
Regulatory challenges have been even more top of mind than usual given recent upheaval at the FDA. BioSpace spoke to three industry experts about key issues, which include applying new artificial intelligence guidance. The experts also shared advice for working with regulators.
After years of contraction, investors see biotech reentering a growth cycle driven by scientific progress, asset quality and renewed conviction in oncology, obesity and neuroscience innovation.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
Fueled by advances in biomarkers, brain mapping, and AI, investment in neuro and CNS innovation shows no signs of slowing, even amid costly setbacks. BioSpace spoke to investors at JPM26 to get their take on recent bets in new therapies and neurotech.
As drug candidates discovered via AI move into later-stage clinical trials, the technology seems to be doing as promised: speeding drug development.
In 2025, made or projected biopharma workforce cuts affected about 42,700 employees, according to BioSpace tallies. BioSpace takes a deep dive into which companies and locations were impacted and speaks to experts about what to expect ahead—and why.
With zasocitinib, Takeda is looking to challenge Bristol Myers Squibb’s kinase inhibitor Sotyktu, for which the Japanese pharma is running a head-to-head study in plaque psoriasis. Takeda expects to file for zasocitinib’s FDA approval next year.
Roche CEO Thomas Schinecker said during the company’s Q3 call that it is “not done” with deals—a promise he delivered on with Tuesday’s solid tumor pact with AI-focused Caris Life Sciences.
At the heart of the deal is Relation’s Lab-in-the-Loop platform, which uses AI models to improve understanding of diseases and guide clinical development programs.
The agency’s sweeping rollout and staff challenge underscore rising momentum behind agentic AI: advanced, multiagent systems now fueling early pilots in medical writing, patient engagement and regulatory workflows across the industry.
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