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Among the 55 novel drugs that crossed the regulatory finish line last year were notable new mechanisms of action, coming particularly in the oncology and neurosciences spaces.

Benefiting from technological and conceptual groundwork and positive early data, gene therapies are advancing in the clinic for cardiovascular diseases including congestive heart failure, chronic refractory angina and cardiomyopathy.

An FDA committee’s September 2024 vote to limit the use of Merck’s Keytruda and BMS’ Opdivo in stomach and esophageal cancers based on PD-L1 expression levels reflects an emerging trend that leverages ever-maturing datasets.

In this short teaser, BioSpace’s Head of Insights Lori Ellis talks to CBER Director Peter Marks and Tom Whitehead, Co-Founder of the Emily Whitehead Foundation about anticipated discussions at the upcoming GenScript Biotech Forum.

Just 61% of hospitals surveyed evaluated models for accuracy on their own data, and less than half evaluated the models for bias.

Research has shown remnant cholesterol is a significant factor in cardiovascular disease risk.

Medtronic and Novo Holdings were among the investors in the funding round.

The Biotech Ecosystem Venture Fund will combine the sourcing capabilities of venture capital firm Andreessen Horowitz (a16z) with Eli Lilly’s expertise in R&D—plus half a billion in capital from the Big Pharma.

After the successful development of mavacamten and the sale of MyoKardia to BMS in 2020, former executives of the biotech are back together with a mission to make cardiovascular disease curable and preventable.

Staff cuts could leave IGM Biosciences with fewer than 55 employees. The company is also halting development of two bispecific antibody T cell engagers for autoimmune diseases.