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Biogen Idec’s Eloctate gains FDA approval

Biogen Idec’s Eloctate gains FDA approval

09-06-2014

The US Food and Drug Administration on Friday approved US biotech firm Biogen Idec’s Eloctate, antihemophilic…

Biogen IdecBiotechnologyEloctateHematologyRegulationSwedish Orphan BiovitrumUSA

US FDA clears Biogen Idec and SOBI’s Alprolix for hemophilia B

US FDA clears Biogen Idec and SOBI’s Alprolix for hemophilia B

31-03-2014

Marking a second regulatory hurdle for the breakthrough product, the US Food and Drug Administration…

AlprolixBenefixBiogen IdecBiotechnologyCSL LimitedHematologyNorth AmericaNovo NordiskPfizerRegulationSwedish Orphan BiovitrumUSA

EU approval for Cometriq in medullary thyroid carcinoma

EU approval for Cometriq in medullary thyroid carcinoma

25-03-2014

The European Commission has approved Cometriq (cabozantinib), a drug for the treatment of adult patients…

BiotechnologyCometriqEuropeExelixisOncologyRegulationSwedish Orphan Biovitrum

US FDA delays Alprolix approval

US FDA delays Alprolix approval

02-12-2013

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

13-11-2013

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

Biogen IdecBiotechnologyEloctateHematologyNorth AmericaRegulationSwedish Orphan Biovitrum

SOBI files for Orfadin oral suspension with EMA

22-08-2013

Swedish Orphan Biovitrum (STO: SOBI) said this morning (August 22) that the company's application for…

EuropeOrfadinPharmaceuticalRare diseasesRegulationSwedish Orphan Biovitrum

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

11-06-2013

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 gains EMA approval for change of Kineret producer; Novartis drops NIC002 project

23-01-2013

Swedish Orphan Biovitrum (STO: SOBI) has received approval from the European Medicines Agency for the…

BiotechnologyBoehringer IngelheimCytos BiotechnologyKineretLicensingNIC002NovartisPharmaceuticalProductionRegulationSwedish Orphan Biovitrum

FDA approves SOBI's Kineret for the treatment of NOMID

08-01-2013

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

07-01-2013

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

Biogen IdecBiotechnologyNorth AmericaRegulationrFIXFcrFVIIIFcSwedish Orphan Biovitrum

News briefs from Sanofi, Biogen/SOBI and Novartis

01-11-2012

French drug major Sanofi (Euronext: SAN) and subsidiary Genzyme have reported results from pivotal studies…

AgrippalBiogen IdecBiotechnologyFluadLemtradaNeurologicalNovartisPharmaceuticalRegulationResearchSanofiSwedish Orphan BiovitrumVaccines

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

27-09-2012

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

Biogen IdecBiotechnologyEuropeNorth AmericaPharmaceuticalRare diseasesRegulationResearchrFIXFcSobiSwedish Orphan Biovitrum

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