FDA and EMA review Biogen's higher dose SMA drug
CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, ...
Pharm Exec5d
Biogen Seeks FDA Approval for a Higher Dosing Regimen of Spinraza for Spinal Muscular Atrophy
Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza (nusinerse) 50 mg taken ...
BioSpace7d
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 ...
GlobalData on MSN7d
Biogen’s higher dose Spinraza under review by US and EU regulators
Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.
Biogen Says FDA And EMA Accept Applications For Higher Dose Regimen Of Nusinersen In SMA
Biogen Inc. (BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New ...
Biogen announces FDA, EMA accepted applications for higher dose of nusinersen
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...
Managed Healthcare Executive6d
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines ...
The Pharma Letter7d
FDA and EMA accept filings for higher dose of nusinersen in SMA
The US Food and Drug Administration (FDA) has accepted Biogen’s supplemental New Drug Application (sNDA) and the European ...
pharmaphorum8y
Biogen courts controversy with $750k-a-year rare disease drug
But now the bad news for patients and healthcare systems: Biogen's list-price annual cost of Spinraza (nusinersen) will be $750,000 for six jabs in the first year of treatment. Although Biogen ...
pharmaphorum7d
US/EU regulators start review of Biogen's high-dose Spinraza
Spinraza remains a big product for Biogen, but has seen its sales go into reverse as competition in SMA treatment has emerged ...
Nasdaq7d
Biogen Says FDA And EMA Accept Applications For Higher Dose Regimen Of Nusinersen In SMA
(RTTNews) - Biogen Inc. (BIIB) announced Thursday that ... has validated the application for a higher dose regimen of nusinersen for spinal muscular atrophy (SMA). The higher dose regimen of ...
Biogen Inc.: FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMA CAMBRIDGE, Mass., Jan. 2 ...