Regulation - Biogen Idec

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Highlights of EMA Pharmacovigilance unit meeting

09-11-2014

At its meeting last week, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee…

BayerBiogen IdecCSL BehringEuropeHelixateHematologyKogenateNeurologicalPharmaceuticalRegulationTecfidera

Biogen Idec and SOBI’s Elocta MAA validated in Europe

01-11-2014

Biotechnology companies Biogen Idec of the USA and Swedish Orphan Biovitrum said on Friday that the European…

Biogen IdecBiotechnologyEloctaEloctateEuropeHematologyRegulationSwedish Orphan Biovitrum

Biogen Idec files for Elocta approval in Europe

Biogen Idec files for Elocta approval in Europe

10-10-2014

US biotech firm Biogen Idec has submitted a Marketing Authorization Application (MAA) for Elocta (rFVIIIFc;…

Biogen IdecBiotechnologyEloctaEloctateEuropeHematologyRegulationSwedish Orphan Biovitrum

NICE recommends Biogen Idec’s Tecfidera for multiple sclerosis

NICE recommends Biogen Idec’s Tecfidera for multiple sclerosis

27-08-2014

The UK’s drugs watch dog, the National Institute for Health and Care Excellence (NICE), has recommended…

Biogen IdecBiotechnologyCNS DiseasesMultiple sclerosisRegulationTecfideraUK

Health Canada OKs Biogen Idec’s hemophilia A therapy Eloctate

Health Canada OKs Biogen Idec’s hemophilia A therapy Eloctate

26-08-2014

Canadian regulator Health Canada has approved US Biotech major Biogen Idec’s Eloctate (antihemophilic…

Biogen IdecBiotechnologyCanadaEloctateHematologyRegulationSwedish Orphan Biovitrum

Biogen Idec’s Plegridy gains US approval for multiple sclerosis

Biogen Idec’s Plegridy gains US approval for multiple sclerosis

17-08-2014

The US Food and Drug Administration has approved US biotech firm Biogen Idec’s (Nasdaq: BIIB) Plegridy…

Biogen IdecBiotechnologyNeurologicalPlegridyRegulationUSA

IQWiG finds no added benefit for Biogen Idec’s Tecfidera

IQWiG finds no added benefit for Biogen Idec’s Tecfidera

08-08-2014

In its early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG)…

Biogen IdecBiotechnologyGermanyMSNeurologicalPricingRegulationTecfidera

Biogen Idec’s Plegridy approved in Europe for relapsing-remitting multiple sclerosis

Biogen Idec’s Plegridy approved in Europe for relapsing-remitting multiple sclerosis

24-07-2014

US biotech firm Biogen Idec said that the European Commission has approved its subcutaneous injectable…

Biogen IdecCytokinesMultiple sclerosisNeurologicalPharmaceuticalPlegridyRegulationUSA

NICE issues positive draft FAD guidance on Tecfidera

NICE issues positive draft FAD guidance on Tecfidera

11-07-2014

UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has issued…

Biogen IdecBiotechnologyMultiple sclerosisNeurologicalPricingRegulationTecfideraUK

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

Positive CHMP opinion for Biogen Idec MS drug Plegridy

25-05-2014

US biotech firm Biogen Idec said on Friday that it had received a positive recommendation from the European…

Biogen IdecBiotechnologyEuropeNeurologicalPlegridyRegulation

Eisai expands deal with Biogen; re-files Fycompa with G-BA; news on Zebinix

Eisai expands deal with Biogen; re-files Fycompa with G-BA; news on Zebinix

12-05-2014

Japanese drug major Eisai has exercised its option to jointly develop and commercialize its clinical…

Biogen IdecEisaiFycompaGermanyItalyLicensingNeurologicalPharmaceuticalPricingRegulationZebinix

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

Health Canada approves Biogen Idec’s long-acting Alprolix hemophilia B

Health Canada approves Biogen Idec’s long-acting Alprolix hemophilia B

21-03-2014

US biotech firm Biogen Idec has announced that Health Canada has approved Alprolix for the control and…

AlprolixBiogen IdecCanadaHematologyPharmaceuticalRegulation

FDA delays approval of Biogen Idec’s MS drug Plegridy

FDA delays approval of Biogen Idec’s MS drug Plegridy

18-03-2014

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

Biogen IdecBiotechnologyNeurologicalNorth AmericaPlegridyRegulationUSA

Australian regulator finds no definite melanoma link for natalizumab

Australian regulator finds no definite melanoma link for natalizumab

18-03-2014

Australia’s Therapeutic Goods Administration revealed today that it is monitoring reports of melanoma…

Asia-PacificAustraliaBiogen IdecBiotechnologyNatalizumabNeurologicalRegulationTysabri

NICE asks Biogen Idec for more information on Tecfidera

NICE asks Biogen Idec for more information on Tecfidera

21-02-2014

The UK’s National Institute for Health and Care Excellence (NICE) is calling on US biotech firm Biogen…

Biogen IdecBiotechnologyCNS DiseasesRegulationTecfideraUK

Biogen’s MS drug Tecfidera approved in EU

Biogen’s MS drug Tecfidera approved in EU

03-02-2014

US biotech firm Biogen Idec’s Tecfidera (dimethyl fumarate) has been approved by the European Commission…

Biogen IdecBiotechnologyEuropeNeurologicalRegulationTecfidera

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

Biogen prevails in EU exclusivity battle for MS drug Tecfidera

Biogen prevails in EU exclusivity battle for MS drug Tecfidera

25-11-2013

US biotech company Biogen Idec saw its shares leap 10% to an all-time high of nearly $278 on Friday,…

Biogen IdecBiotechnologyEuropeNeurologicalPatentsRegulationTecfidera

2013 FDA approval rates suggest record year for post-launch success

14-11-2013

A focus on hard to treat or specialist diseases is set to result in record post-launch sales for new…

Biogen IdecFinancialGilead SciencesNorth AmericaPharmaceuticalRegulationsofosbuvirTecfidera

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

Roche’s Gazyva gains FDA approval of CLL

Roche’s Gazyva gains FDA approval of CLL

04-11-2013

The US Food and Drug Administration late Friday approved Roche’s Gazyva (obinutuzumab), also known…

Biogen IdecBiotechnologyGazyvaGenentechMabTheraNorth AmericaobinutuzumabOncologyRegulationRituxanRoche

US FDA warns of hepatitis B reactivation risk with Arzerra and Rituxan

US FDA warns of hepatitis B reactivation risk with Arzerra and Rituxan

26-09-2013

The US Food and Drug Administration has approved changes to the prescribing information of the immune-suppressing…

Anti-Arthritics/RheumaticsArzerraBiogen IdecGlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationRituxanRoche

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