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Samsung Bioepis' Enbrel biosimilar candidate SB4 accepted for review by EMA

Samsung Bioepis' Enbrel biosimilar candidate SB4 accepted for review by EMA

21-01-2015

South Korea’s Samsung Bioepis says that the Marketing Authorization Application for its Enbrel (etanercept)…

AmgenAnti-Arthritics/RheumaticsBiogen IdecBiosimilarsBiotechnologyEnbrelEuropePfizerRegulationSamsung Bioepis

Novartis’ Cosentyx gets third approval, now in Europe

19-01-2015

The European Commission (EC) has approved Swiss pharma giant Novartis’ Cosentyx (secukinumab, formerly…

BiotechnologyCosentyxDermatologicalsEuropeNovartisRegulation

Celgene’s oral Otezla approved by EC for psoriasis and psoriatic arthritis

Celgene’s oral Otezla approved by EC for psoriasis and psoriatic arthritis

18-01-2015

US biotech firm Celgene’s European subsidiary has received marketing authorization from the European…

Anti-Arthritics/RheumaticsBiotechnologyCelgene CorpDermatologicalsEuropeOtezlaRegulation

EMA accepts Sanofi and Regeneron's MMA for Praluent for review

EMA accepts Sanofi and Regeneron's MMA for Praluent for review

12-01-2015

French drug major Sanofi and US biotech company Regeneron have announced that the European Medicines…

alirocumabBiotechnologyCardio-vascularEuropeRegeneronRegulationSanofi

Shire to spend $5.2 billion to buy NPS Pharma

Shire to spend $5.2 billion to buy NPS Pharma

12-01-2015

Recently jilted Ireland-headquartered Shire says it is to acquire NPS Pharmaceuticals, confirming recent…

BiotechnologyEuropeGattexMergers & AcquisitionsNatparaNPS PharmaceuticalsRare diseasesRevestiveShire

Sobi extends distribution agreement with Exelixis for Cometriq

Sobi extends distribution agreement with Exelixis for Cometriq

07-01-2015

Swedish Orphan Biovitrum today announced that its agreement with Exelixis has been restructured and extended…

BiotechnologyCometriqEuropeExelixisMarkets & MarketingOncologySobi

Janssen and Gilead expand agreement to develop HIV single-tablet regimen

Janssen and Gilead expand agreement to develop HIV single-tablet regimen

29-12-2014

US health care giant Johnson & Johnson’s Ireland-based subsidiary Janssen R&D Ireland has amended its…

Anti-viralsBiotechnologyCompleraEuropeGileadJanssenPrezistaResearchTybost

Novartis’ Cosentyx wins positive opinion from EMA’s CHMP

Novartis’ Cosentyx wins positive opinion from EMA’s CHMP

21-11-2014

Swiss pharma giant Novartis this morning revealed that the European Medicines Agency’s Committee for…

BiotechnologyCosentyxDermatologicalsEuropeNovartisRegulationsecukinumab

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

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