Biogen, SMA
Biogen Trims Research Workforce, Higher-Dose SMA Drug Accepted for Regulatory Review
In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of its Ionis-partnered therapy Spinraza for spinal muscular atrophy will be considered by the FDA and EMA.
Biogen Gets U.S., European Reviews of Higher-Dose Spinraza
Biogen said the U.S. Food and Drug Administration has accepted its supplemental new-drug application, while the European Medicines Agency has validated its application, which confirms that the submission is complete and starts the EMA's centralized review process.
Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza (nusinerse) 50 mg taken ...
Spinraza remains a big product for Biogen, but has seen its sales go into reverse as competition in SMA treatment has emerged ...
Biogen Inc. announced that the FDA has accepted and the EMA has validated its supplemental New Drug Application for a higher dose regimen of nusinersen, intended for treating spinal muscular ...
Shares of Biogen Inc. (NASDAQ:BIIB – Get Free Report) have earned a consensus rating of “Hold” from the twenty-eight ratings firms that are covering the company, MarketBeat.com reports. Sixteen ...
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