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Northwest Bio says DCVax-L hospital exemption program under way in Germany

Northwest Bio says DCVax-L hospital exemption program under way in Germany

15-10-2014

US biotech firm Northwest Biotherapeutics, which is developing DCVax personalized immune therapies for…

BiotechnologyDCVax-LGermanyNorthwest BiotherapeuticsOncologyRegulationResearch

IQWiG finds added benefit of Novartis’ Gilenya not proven

IQWiG finds added benefit of Novartis’ Gilenya not proven

10-10-2014

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products…

GermanyGilenyaNeurologicalNovartisPharmaceuticalPricingRegulation

Added benefit for certain patients found by IQWiG with Janssen’s Olysio

Added benefit for certain patients found by IQWiG with Janssen’s Olysio

15-09-2014

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products…

Anti-viralsGermanyJanssenJohnson & JohnsonOlysioPharmaceuticalPricingRegulation

Compromised vials of Roche's MabThera found in Germany

Compromised vials of Roche's MabThera found in Germany

15-09-2014

Swiss drug major Roche has said that compromised vials of its arthritis and cancer drug MabThera had…

GermanyHerceptinLegalMabTheraOncologyPharmaceuticalProductionRegulationRoche

IQWiG finds added benefit for Novartis’ Jakavi in myelofibrosis

IQWiG finds added benefit for Novartis’ Jakavi in myelofibrosis

20-08-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products,…

Federal Joint CommitteeGermanyJakaviMyelofibrosisNovartisOncologyPharmaceuticalPricingRare diseasesRegulation

IQWiG again turns down Eisai’s epilepsy drug Fycompa

IQWiG again turns down Eisai’s epilepsy drug Fycompa

17-08-2014

The German Institute for Quality and Efficiency in Healthcare (IQWiG) has said that epilepsy drug Fycompa…

EisaiEpilepsyFycompaGermanyNeurologicalPharmaceuticalPricingRegulation

Added benefit of Novo Nordisk’s Tresiba not proven, says IQWiG

Added benefit of Novo Nordisk’s Tresiba not proven, says IQWiG

08-08-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

DiabetesGerman Institute for Quality and EfficiencyGermanyNovo NordiskPharmaceuticalPricingRegulationTresiba

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

BMJ alleges Boehringer Ingelheim withheld Pradaxa dosing information from regulators

BMJ alleges Boehringer Ingelheim withheld Pradaxa dosing information from regulators

24-07-2014

German family-owned drug major Boehringer Ingelheim has been accused of withholding ‘important analyses’…

Boehringer IngelheimDabigatranGermanyHematologyPharmaceuticalPradaxaPyridinesRegulationUKUniversity of California

Breast cancer: DMP is largely consistent with guidelines, says IQWiG

Breast cancer: DMP is largely consistent with guidelines, says IQWiG

16-07-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) has today published the results…

Breast cancerGermanyInstitute for Quality and Efficiency in Health CareOncologyPharmaceuticalRegulation

CellAct Pharma receives orphan drug designation in EU for cancer drug

CellAct Pharma receives orphan drug designation in EU for cancer drug

16-07-2014

The European Medicines Agency’s Committee for Orphan Medicinal Products has granted German cancer specialists…

CAP7.1CellAct PharmaEuropeGermanyHepatologyOncologyPharmaceuticalRegulationTreatment of biliary tract cancers

Added benefit of Invokana in type 2 diabetes is not proven, says IQWiG

Added benefit of Invokana in type 2 diabetes is not proven, says IQWiG

17-06-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

DiabetesGermanyInvokanaJanssen-CilagJohnson & JohnsonPharmaceuticalPricingRegulation

Boehringer resolves FDA manufacturing facility concerns

Boehringer resolves FDA manufacturing facility concerns

03-06-2014

German family-owned pharma major Boehringer Ingelheim said today that it has been notified by a letter…

Boehringer IngelheimFood and Drug AdministrationGermanyPharmaceuticalPharmaceutical sciencesProductionRegulationResearchUSA

EMA “look, but don’t touch” terms of use for clinical study data are impracticable, says IQWiG

EMA “look, but don’t touch” terms of use for clinical study data are impracticable, says IQWiG

28-05-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) has taken issue with plans announced…

EuropeGermanyPharmaceuticalRegulationResearch

IQWIG finds added benefit in adult patients for VIIV Healthcare’s Tivicay

27-05-2014

In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG),…

Anti-viralsGermanyGlaxoSmithKlinePharmaceuticalPricingRegulationTivicayViiV Healthcare

Negative IQWiG view on AstraZeneca’s combo diabetes drug Xigduo

16-05-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

AstraZenecaDiabetesGermanyPharmaceuticalPricingRegulationXigduo

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

IQWiG finds added benefit for Novo Nordisk’s NovoEight not proven

23-04-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

GermanyHematologyNorthern EuropeNovo NordiskNovoEightPharmaceuticalPricingRegulation

GSK’s Tafinlar also no added benefit over vemurafenib, says IQWiG

GSK’s Tafinlar also no added benefit over vemurafenib, says IQWiG

09-04-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

GermanyGlaxoSmithKlineNorthern EuropeOncologyPharmaceuticalPricingRegulationTafinlarvemurafenib

Germany’s IQWiG views Xofigo, Kadcyla and Eviplera

03-04-2014

In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products, the…

Anti-viralsBayerEvipleraGermanyGilead SciencesKadcylaNorthern EuropeOncologyPharmaceuticalPricingRegulationRocheXofigo

Added benefit for non-pre-treated Yervoy patients in advanced melanoma not proven, says IQWiG

Added benefit for non-pre-treated Yervoy patients in advanced melanoma not proven, says IQWiG

19-03-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) has re-assessed the added benefit…

Bristol-Myers SquibbGermanyNorthern EuropeOncologyPharmaceuticalPricingRegulationYervoy

IQWiG now finds “major” benefit for Xtandi

24-02-2014

In an early benefit assessment under Germany’s Act on the Reform of the Market for Medicinal Products…

Astellas PharmaGermanyMedivationNorthern EuropeOncologyPharmaceuticalPricingRegulationXtandi

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