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US FDA delays Alprolix approval

US FDA delays Alprolix approval


The US Food and Drug Administration (has extended the initial Prescription Drug User Fee Act date for…

AlprolixBiogen IdecBiotechnologyHematologyNorth AmericaRegulationSwedish Orphan BiovitrumUSA

US FDA calls for further data on Biogen Idec’s Eloctate

US FDA calls for further data on Biogen Idec’s Eloctate


Swedish Orphan Biovitrum has announced that its partner, US biotech major Biogen Idec, has received a…

Biogen IdecBiotechnologyEloctateHematologyNorth AmericaRegulationSwedish Orphan Biovitrum

SOBI gets FDA approval to manufacture substance for Kineret with partner Boehringer Ingelheim


Swedish Orphan Biovitrum (STO: SOBI) said today (June 11) that it has received approval from the US Food…

Boehringer IngelheimInflammatory diseasesKineretNorth AmericaPharmaceuticalProductionRegulationSavient PharmaceuticalsSwedish Orphan Biovitrum

SOBI links with Savient for co-promotion of Kineret in USA


Swedish Orphan Biovitrum (STO: SOBI) says it has entered into an agreement with USA-based Savient Pharmaceuticals…

Anti-Arthritics/RheumaticsInflammatory diseasesKineretLicensingMarkets & MarketingNorth AmericaPharmaceuticalSavient PharmaceuticalsSobiSwedish Orphan Biovitrum

FDA approves SOBI's Kineret for the treatment of NOMID


Biotech firm Swedish Orphan Biovitrum (STO: SOBI) today announced that the US Food and Drug Administration…

AmgenBiotechnologyInflammatory diseasesKineretNorth AmericaRegulationSobiSwedish Orphan Biovitrum

Biogen Idec files for US approval of hemophilia B treatment


US biotech firm Biogen Idec (Nasdaq: BIIB) on Friday announced it has submitted a Biologics License Application…

Biogen IdecBiotechnologyNorth AmericaRegulationrFIXFcrFVIIIFcSwedish Orphan Biovitrum

Positive Ph III results for Biogen Idec and SOBI's hemophilia B agent


US biotech firm Biogen Idec (Nasdaq: BIIB) and partner Swedish Orphan Biovitrum (STO: SOBI) have announced…

Biogen IdecBiotechnologyEuropeNorth AmericaPharmaceuticalRare diseasesRegulationResearchrFIXFcSobiSwedish Orphan Biovitrum

Company Spotlight

Eleven Biotherapeutics

Eleven Biotherapeutics

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