Biogen
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The company sent the medication to a Florida neurology clinic free of charge.
Ginkgo has signed multiple collaborations, announced a breakthrough in manufacturing mRNA vaccine components, and landed an SPAC deal.
Eisai said that they have initiated communication with the FDA to achieve “the most optimal regulatory pathway” for lecanemab.
Shares of Ardelyx, Inc. have fallen nearly 13% in premarket trading after the U.S. FDA rejected the company’s chronic kidney disease drug, tenapanor.
Biogen reportedly withdrew a paper it had submitted to the medical journal JAMA after the publication requested edits before publication. It’s standard for a technical journal to request edits, but it is the nature of the edits—and in this case, the nature of the study— that raises questions.
One of the eagerly anticipated presentations at the AAIC being held this week is Biogen and its partner Eisai on their controversial drug ADUHELM™ (aducanumab). Biogen is also presenting new data on a different Alzheimer’s drug with another partner, Ionis Pharmaceuticals.
Phase one launched last week after patients who had been on placebo in Biogen’s pivotal phase III VALOR study were transitioned to active therapy.
The company also issued an open letter to the Alzheimer’s disease community from Alfred Sandrock, which attempts to push back against negative media attention.
The antibody is still being evaluated in clinical studies, with a large-scale Phase III trial expected to wrap in the second half of 2022.
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