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From Early 2020 To Q3: Biogen Shifts Aducanumab Filing Expectations Again

Executive Summary

The company remains confident in US FDA approval for the first disease-modifying Alzheimer’s drug based on current data, but Biogen needs more time to complete the BLA filing.

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Biogen/Eisai Hit ‘Send’ On High Stakes BLA For Aducanumab In Alzheimer’s Disease

Some analysts see a 50-50 chance of US FDA approval despite the controversial dataset for the anti-amyloid antibody, but at least one expects an eventual CRL requesting a third Phase III trial.

Mylan Triumphs In Tecfidera Patent Challenge

Following a district court decision invalidating the '514 patent for Tecfidera, Mylan says it looks forward to launching a generic after final FDA approval is granted, despite Biogen saying it will appeal the ruling. The ANDA has a November action date.

Biogen's Tecfidera Future Uncertain After Patent Challenge Loss To Mylan

Biogen said it will appeal the district court decision invalidating the '514 patent for Tecfidera but Mylan said it looks forward to launching a generic after final FDA approval is granted. The ANDA has a November action date.  

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