Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Bio­gen has flagged a pair of set­backs in the pipeline, spot­light­ing the fi­nal fail­ure for a one-time top MS prospect while scrap­ping a gene ther­a­py for SMA af­ter the IND was put on hold due to tox­i­c­i­ty.

Both fail­ures will raise the stakes even high­er on ad­u­canum­ab, the Alzheimer’s drug that Bio­gen is bet­ting the ranch on, de­ter­mined to pur­sue an FDA OK de­spite sig­nif­i­cant skep­ti­cism they can make it with mixed re­sults and a re­liance on post hoc da­ta min­ing. And the fail­ures are be­ing re­port­ed as Bio­gen was forced to cut its prof­it fore­cast for 2020 as a gener­ic ri­val start­ed to erode their big fran­chise drug.

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