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Gilead Sciences’ Harvoni gains EU approval

Gilead Sciences’ Harvoni gains EU approval

19-11-2014

The European Commission yesterday granted marketing authorization for US biotech antiviral specialists…

Anti-viralsBiotechnologyEuropeGilead SciencesHarvoniRegulationSovaldi

Increased scrutiny by EU5 health authorities will encourage off-label use of Avastin for wet-AMD

06-11-2014

Cost-constrained health authorities in the EU5 (France, Germany, Italy, Spain, and the UK) are increasingly…

AvastinBiosimilarsBiotechnologyEuropeFinancialLucentisMarkets & MarketingNovartisOphthalmicsRoche

GlaxoSmithKline files for US and EU approval of mepolizumab

GlaxoSmithKline files for US and EU approval of mepolizumab

05-11-2014

UK pharma major GlaxoSmithKline says it has filed regulatory submissions in the USA and Europe for mepolizumab…

BarclaysBiotechnologyBosatriaEuropeGlaxoSmithKlineImmunosuppressantsmepolizumabRegulationRespiratory and PulmonaryUnited StatesUSA

Vertex seeks regulatory approval for lumacaftor/ivacaftor combination for CF

05-11-2014

US biotech firm Vertex Pharmaceuticals has filed for marketing approval for a fully co-formulated combination…

BiotechnologyEuropeivacaftorlumacaftorRare diseasesRegulationUSAVertex Pharmaceuticals

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

EMA guidance on facilitating global development of biosimilars

EMA guidance on facilitating global development of biosimilars

30-10-2014

The European Medicines Agency has published its revised overarching guideline on biosimilars, or follow-on…

BiosimilarsBiotechnologyEuropeRegulation

EuropaBio’s new White Paper 'Realising the Potential of Personalized Medicine in Europe'

27-10-2014

Biotechnology trade group EuropaBio has issued a new White Paper, aiming to identify the required adaptations…

BiotechnologyEuropeRegulationResearch

Janssen commits $200 million to speeding up Ebola vaccine development and increasing production

Janssen commits $200 million to speeding up Ebola vaccine development and increasing production

22-10-2014

US health care giant Johnson & Johnson is to commit up to $200 million to accelerate and expand the production…

Antibiotics and Infectious diseasesBavarian NordicBiotechnologyEuropeJanssenResearch

Janssen files for EU approval of Stelara in pediatric plaque psoriasis

13-10-2014

Janssen-Cilag International says that a Type II Variation has been filed with the European Medicines…

BiotechnologyDermatologicalsEuropeInflammatory diseasesJanssen-CilagJohnson & JohnsonRegulationStelara

Bristol-Myers Squibb, Pharmacyclics and Janssen team up to test Opdivo and Imbruvica combination

Bristol-Myers Squibb, Pharmacyclics and Janssen team up to test Opdivo and Imbruvica combination

13-10-2014

US drug major Bristol-Myers Squibb, US-based biopharma company Pharmacyclics and Janssen Research and…

BiotechnologyBristol-Myers SquibbEuropeImbruvicaJanssenOncologyOpdivoPharmacyclics

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

Biotherapies could save millions of euros when treating auto-immune diseases

Biotherapies could save millions of euros when treating auto-immune diseases

08-10-2014

Health care providers could save millions of euros if biotherapies were used in the treatment of Crohn’s…

Anti-Arthritics/RheumaticsBiotechnologyEuropeFinancialHealthcareResearchTheradiag

Incyte earns $60 million milestone on European reimbursement for Jakavi

Incyte earns $60 million milestone on European reimbursement for Jakavi

02-10-2014

US biopharma company Incyte says that it has earned a $60 million milestone payment from Swiss pharma…

BiotechnologyEuropeFinancialIncyteJakafiJakaviNovartisOncologyPricing

European Commission approves Gilead’s Zydelig for blood cancer

European Commission approves Gilead’s Zydelig for blood cancer

19-09-2014

The European Commission has granted marketing authorization for US biotech major Gilead Sciences’ Zydelig…

BiotechnologyEuropeGilead SciencesLymphomaMedicineOncologyRegulationZydelig

EuropaBio calls for EMA action on labeling of biosimilars

18-09-2014

EuropaBio has published a statement giving the perspective of the health care biotechnology industry…

BiosimilarsBiotechnologyEuropeRegulation

EU approval for Octapharma's Nuwiq across all age groups in hemophilia A

EU approval for Octapharma's Nuwiq across all age groups in hemophilia A

07-08-2014

The European Commission has approved independent Swiss biotech firm Octapharma's Nuwiq (simoctocog alfa)…

BiotechnologyEuropeHematologyNuwiqOctapharmaRegulation

Chiesi and uniQure delay Glybera launch to add data

Chiesi and uniQure delay Glybera launch to add data

04-08-2014

Netherlands-based venture capital backed human gene therapy firm uniQure and privately-held Italian drugmaker…

BiotechnologyChiesi FarmaceuticiEuropeGlyberaOrphan disease lipoprotein lipase deficiencyPricingRare diseasesRegulationuniQure

Orphan status in Europe for Alexion’s Soliris in myasthenia gravis

Orphan status in Europe for Alexion’s Soliris in myasthenia gravis

01-08-2014

The European Commission has granted orphan drug designation (ODD) to US drugmaker Alexion Pharmaceuticals’…

Alexion PharmaceuticalsBiotechnologyEuropeEuropean CommissionMyasthenia gravisNeurologic disorderRare diseasesRegulationSoliris

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