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Korsana’s lead program uses a next-generation shuttling technology to improve delivery into the brain and lower the incidence of amyloid-related imaging abnormalities.
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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.
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Read our takes on the biggest stories happening in the industry.
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.
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Last month, the FDA declined to approve Sanofi’s tolebrutinib for a specific form of multiple sclerosis. In a recently published complete response letter, the agency detailed its reasoning behind the rejection.
While Zenas’ obexelimab hit the primary endpoint in the Phase III INDIGO study, it came far below the efficacy threshold set by Amgen’s B cell depleter Uplizna, approved by the FDA for IgG4-related disease last April.
The agreement, which BMO Capital Markets called a “mild positive” for Structure, appears to address Roche’s concerns about the composition of investigational weight loss drug CT-996.
OncoNano’s platform, called ON-BOARD, packages drugs in pH-sensitive micelles that ensure their specific delivery near tumors, while also preventing systemic exposure.
Next-generation automation is closing the gap between curative science and real-world demand, enabling faster development, global consistency and broader patient access to CAR T therapies.
After a strong open to the year, the public markets suffered a six-month drought that led to biotech’s tightest IPO window in years.
Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
In a year that saw advisory committees placed under a particularly bright microscope at the FDA, the agency held fewer meetings than usual and agreed with its advisors only 57% of the time, Jefferies reported.
Industry leaders are focused on the resilience of key starting material supply and the knock-on effects of automation in the new year.
The fierce rivalry between Novo Nordisk and Eli Lilly is alive and well, as the two companies are expected to face off with their new obesity pills this year.