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C2N Diagnostics, LLC

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Latest From C2N Diagnostics, LLC

Leqembi’s EU Approval Process Delayed Over Advisory Group COI Considerations

The EU regulatory agency’s discussions for lecanemab’s approval are hit by a decision to annul advice from an advisory committee due to the implications of a Court of Justice ruling on the handling of experts' competing interests.

Europe Drug Review

Leqembi Treatment Infrastructure: If Medicare Pays For It, They Will Come

The biggest barrier for Eisai/Biogen’s Alzheimer’s medicine Leqembi was Medicare. With full US FDA approval and Medicare coverage in place, PET scan, MRI and infusion centers are needed to facilitate treatment.

Launches Market Access

ADDF’s Fillit On FDA’s Tough Aducanumab Decision, Advances In Alzheimer’s

The pending US FDA decision on Biogen’s drug overshadows progress in Alzheimer’s diagnosis, symptomatic treatments and the need to keep studying anti-tau therapies after Roche’s setback.

Neurology Innovation

AbbVie’s Five Biggest Priorities, Apart From Allergan

While it works on merging with Allergan, AbbVie is tracking biosimilar sales erosion to Humira, the promising launch of Skyrizi and the growth of Imbruvica and Venclexta. It is terminating a Phase II study of a tau-targeting antibody and worried about aspects of the Senate drug pricing bill.

Sales & Earnings Commercial
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