Biogen
NEWS
Amylyx’s decision to submit the NDA, announced Wednesday morning, came on the heels of recent discussions with the FDA, including a pre-NDA meeting held on July 15.
The top three clusters from last year’s list - Greater Boston, San Francisco Bay Area and San Diego - all stood their ground and maintained their rankings from the previous year.
The growth of fibril tips is thought to be the ‘Achilles’ heel’ of the process.
Biogen CEO Michel Vounatsos admitted Thursday that the company’s rollout of Aduhelm (aducanumab) for Alzheimer’s disease has been “slower than we anticipated.”
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.
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