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Latest From UCB S.A.

Eisai/Biogen’s Leqembi Breezes Through Adcomm; Labeling Discussions With US FDA May Be Knottier

To get regular approval, the Alzheimer’s treatment could see tightened labeling on the need to test for ApoE ε4 status given advisory committee recommendations. Some panelists also raised concerns around use with anticoagulants and in patients with cerebral amyloid angiopathy.

Advisory Committees Drug Review

Eisai/Biogen’s Leqembi Breezes Through Adcomm; Labeling Discussions With US FDA May Be Knottier

To get regular approval, the Alzheimer’s treatment could see tightened labeling on the need to test for ApoE ε4 status given advisory committee recommendations. Some panelists also raised concerns around use with anticoagulants and in patients with cerebral amyloid angiopathy.

Advisory Committees Drug Review

FibroGen Misses In First Of Two Pivotal DMD Trials

The biotech’s pamrevlumab fails a Phase III study in non-ambulatory Duchenne muscular dystrophy, but the antibody still has a shot in ambulatory DMD, as well as IPF and pancreatic cancer.

Clinical Trials Business Strategies

Akero Shows FGF21/GLP-1 Combo’s Potential In NASH And Type 2 Diabetes

Phase IIb data show that Akero’s efruxifermin on top of GLP-1 therapy is relatively safe and offers liver fat reductions and fibrosis improvements in NASH patients with type 2 diabetes.

Clinical Trials Business Strategies
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    • Celltech Pharmaceuticals, Inc.
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    • Engage Therapeutics, Inc., Ra Pharmaceuticals, Inc.
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