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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

SOBI’s Kiobrina pivotal Ph III study fails to meet primary endpoint

SOBI’s Kiobrina pivotal Ph III study fails to meet primary endpoint

27-03-2014

Stockholm-based Swedish Orphan Biovitrum has released disappointing top-line results from a Phase III…

BiotechnologyKiobrinaMetabolicsResearchSwedish Orphan Biovitrum

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 updates on Kepivance and SOB1002 development

SOBI updates on Kepivance and SOB1002 development

05-11-2013

At its Capital Market Day event on November 5, Swedish Orphan Biovitrum shared information regarding…

Inflammatory diseasesKepivanceKiobrinaOncologyPharmaceuticalResearchSOB1002SobiSwedish Orphan Biovitrum

SOBI gains rights to distribute Ravicti in Middle East

01-10-2013

Swedish Orphan Biovitrum says Hyperion Therapeutics has granted it exclusive rights to distribute its…

Genito-urinaryHyperion TherapeuticsLicensingPharmaceuticalRavictiRest of the WorldSobiSwedish Orphan Biovitrum

SOBI restructures Kineret and Kepivance deals

09-09-2013

Swedish Orphan Biovitrum (STO: SOBI) said this morning that it has acquired the full rights to develop…

AmgenAnti-Arthritics/RheumaticsBiotechnologyKepivanceKineretLicensingOncologyPharmaceuticalRare diseasesSwedish 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

Auxilium and SOBI collaborate on Xiapex

16-07-2013

USA-based Auxilium Pharmaceuticals (Nasdaq: AUXL) and Swedish Orphan Biovitrum (STO: SOBI) have entered…

Auxilium PharmaceuticalsEuropeLicensingPharmaceuticalRare diseasesRest of the WorldSwedish Orphan BiovitrumXiapex

New data support safety and efficacy of Biogen Idec and SOBI's Alprolix

03-07-2013

US biotech firm Biogen Idec (Nasdaq: BIIB) and Swedish Orphan Biovitrum (STO: SOBI) yesterday presented…

AlprolixBiogen IdecBiotechnologyPharmaceuticalResearchSwedish 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 to distribute Exelixis' cancer drug Cometriq in EU

22-02-2013

US biotech firm Exelixis (Nasdaq: EXEL) has entered into a three-year with Swedish Orphan Biovitrum (STO:…

BiotechnologyCometriqEuropeExelixisLicensingOncologySobiSwedish Orphan Biovitrum

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

19-02-2013

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

SOBI gains distribution rights for Megace, Monopril, Cefzil and Duricef from PharmaSwiss

13-02-2013

Swedish Orphan Biovitrum (STO: SOBI) says that it has entered into a distribution agreement with privately-held…

Antibiotics and Infectious diseasesCardio-vascularCefzilDuricefEuropeLicensingMegaceMonoprilOncologyPharmaceuticalPharmaSwissSobiSwedish 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

Sobi and Biogen Idec flesh out details of hemophilia programs

06-02-2012

Stockholm-based Swedish Orphan Biovitrum (STO: SOBI) and US biotech company Biogen Idec (Nasdaq: BIIB)…

Biogen IdecBiotechnologyCardio-vascularLicensingPharmaceuticalSwedish Orphan Biovitrum

Sobi buys rights to novel neonatology treatment

16-01-2012

Stockholm-based Swedish Orphan Biovitrum (STO: SOBI) has signed a global licensing agreement with the…

BumetanideCardio-vascularLicensingNeurologicalOnly for Children PharmaceuticalsPharmaceuticalSwedish Orphan Biovitrum

Pharming extends Ruconest deal with SOBI

16-08-2011

Netherlands-based biotech firm Pharming Group NV (Euronext: PHARM) has extended its existing agreement…

BiotechnologyEuropeLicensingPharmaceuticalPharmingRare diseasesRest of the WorldRhucinRuconestSwedish Orphan Biovitrum

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