Biogen
NEWS
Biogen has withdrawn its Marketing Authorization Application (MAA) for European approval of Aduhelm after regulators hinted data was not strong enough to support potential approval.
The U.S. FDA’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.
Following the decision to limit the coverage of Biogen’s controversial Alzheimer’s drug Aduhelm, the Alzheimer’s community is now waiting for other companies to deliver new therapies.
Shares of Biogen are falling in post-market trading after the U.S. government officially announced it will limit coverage of the company’s controversial Alzheimer’s drug Aduhelm to patients in clinical trials.
It was a particularly busy week for clinical trial announcements. Let’s take a look.
Biogen will await word after submitting the final study protocol for its confirmatory Phase IV ENVISION trial of Aduhelm to the U.S. Food and Drug Administration (FDA).
A team at the University of California, San Diego developed a drug screening method to help determine why Alzheimer’s drugs fail. The system analyzes disease mechanisms in human neurons.
Lately, there has been heightened attention to briefing documents in the CNS space, a notoriously tricky area to get drugs approved, which can affect company stock prices.
Biogen and Ionis Pharmaceuticals announced that their Phase I study of BIIB078 (IONIS-C9Rx) intended for ALS did not meet clinical endpoints, so they will discontinue the program.
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