Phase I
Company shares fell over 50% after two late-stage studies failed to demonstrate vision improvements in patients with diabetes macular edema.
The Federal Trade Commission released new draft guidelines for assessing mergers, while an Alzheimer’s conference yielded promising data and J&J kicked off Q2 earnings season with a sound beat.
The program—a joint initiative between CDER and CBER—aims to accelerate the development of therapies for rare diseases.
With Eisai and Biogen’s Leqembi now fully approved, researchers are exploring combinations—including with therapies targeting tau and microglial function—that could increase its effectiveness.
In a Phase I trial, Caribou’s allogeneic CAR-T cell therapy candidate induced high rates of treatment response in patients with relapsed or refractory B cell non-Hodgkin lymphoma.
Recent data from the Phase III study of donanemab emphasize a correlation between amyloid and tau. Experts say a greater understanding of this link could further Alzheimer’s drug development.
The FDA recently approved the first cellular therapy for Type 1 diabetes and others may not be far behind. But experts say challenges still exist to the widespread application of these treatments.
Early-stage data shows that Viridian’s thyroid eye disease candidate induces clinically meaningful improvements in eye protrusion after six weeks of treatment.
Gene editing technologies are advancing rapidly in the clinic, with the potential first approval later this year, but challenges remain.
Phase I/II data on AbbVie and Genmab’s recently approved bi-specific antibody in a second cancer indication positions them to talk to regulators about filings to challenge Roche’s Lunsumio.
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