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Latest From Biocodex

EMA OKs BMS/bluebird bio’s CAR-T Abecma For Multiple Myeloma

A gene therapy for multiple myeloma, a new drug for achondroplasia, and the first biosimilar version of Roche’s Lucentis are among eight products recommended for EU marketing authorization this week.

Approvals Drug Review

Takeda Takes Back Dravet, Lennox-Gastaut Candidate From Ovid

Revising the two companies’ 2017 epilepsy collaboration, Takeda will take over Phase III development and commercialization of soticlestat. Ovid gets $196m up front, and it can shift focus.

Deals Rare Diseases

Takeda/Ovid Plan Phase III For Soticlestat In Dravet Syndrome, But Pull Back On LGS

A Phase II trial of the CH24H inhibitor showed a statistically significant benefit in children with the rare epilepsy syndrome Dravet Syndrome, but not in Lennox-Gastaut syndrome (LGS).

Neurology Clinical Trials

Keeping Track Of US FDA Decisions: COVID-Induced Complete Response Letter For Contepo; Safety Sinks Abicipar Pegol; Approvals For Fintepla and Gimoti

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Coronavirus COVID-19
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