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Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized.
Long an R&D company that partnered off assets, RNAi biotech Ionis Pharmaceuticals shifted in 2025 to bring two medicines to market alone. Analysts are already impressed—and there’s more to come in 2026.
An analysis finds that pharmas frequently file multiple similar patents on drugs, then use them as the basis for questionable litigation against would-be competitors.
Job Trends
Follow along as BioSpace tracks job cuts and restructuring initiatives.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
THE LATEST
The Federal Trade Commission has asked for an additional 30 days for its review of Novo Nordisk’s $16.5 billion acquisition of Catalent, with the companies expecting to complete the merger by the end of 2024.
Jeffrey Chamberlain, president of the American Society of Gene & Cell Therapy, spoke with BioSpace about what we can expect to learn about in Baltimore this week.
Adeno-associated viruses have long been go-to vectors for gene therapies. How AAVs are improving will be among the cell and gene therapy topics to be covered in Baltimore this week.
The New Jersey-based biopharma will use the funds to support a Phase II study of its serotonergic psychedelic drug candidate in postpartum depression.
In an effort to improve diversity and accessibility in clinical trials, Boehringer Ingelheim is partnering with Walgreens to conduct a Phase III study in obesity and type 2 diabetes.
Follow News Editor Greg Slabodkin and Managing Editor Jef Akst as they travel with some 8,000 others for discussions of cell and gene therapy advances, challenges, regulations and more.
It wasn’t calls from lawmakers but market competition with Eli Lilly’s Zepbound that prompted Novo Nordisk to lower the prices of its blockbuster weight-loss drug.
Since the 2022 launch of ChatGPT, biopharma has poured money into this new form of artificial intelligence, but companies remain cautious with unproven technology.
Ahead of the FDA’s June target action date for Sarepta’s Duchenne muscular dystrophy gene therapy, ICER Chief Medical Officer David Rind blasted the regulator’s accelerated pathway in a JAMA viewpoint article.
AstraZeneca’s blockbuster BTK inhibitor Calquence significantly improved progression-free survival when used as a frontline treatment in patients with mantle cell lymphoma, according to Thursday’s late-stage results.