Biogen has withdrawn the EU filing for Alzheimer’s drug Aduhelm after European Medicines Agency experts confirmed that doubts about its safety and efficacy meant it could not be approved.
Another Blow To Aduhelm As Biogen Withdraws EU Filing
Adds To US Commercial Failure
Biogen has withdrawn its filing of the Alzheimer’s drug before the EMA could reject it for the second time, perhaps hoping it could return with better data.
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GNT Pharma prepares for the first listing of a Korean biotech on Nasdaq, while others sign major global out-licensing deals with large multinational partners.
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With the FDA asking for another Phase III trial, the short bowel syndrome drug apraglutide could be years away from market, while the Linzess patent expiry and near-term debt loom.
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The company discontinued development of its oral GLP-1 receptor agonist for weight management due to a safety signal.
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The Oxford group has linked up with the NHS Cancer Vaccine Launch Pad.
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The bispecific is the first in its class to record a Phase III survival win in small-cell lung cancer, although antibody-drug conjugates and other rivals could challenge in the coming years.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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The Oxford group has linked up with the NHS Cancer Vaccine Launch Pad.