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Trade groups call for integrated life science strategy ahead of European Commission Work Program

Trade groups call for integrated life science strategy ahead of European Commission Work Program

16-12-2014

European research and generic/biosimilar industry associatins have called for an integrated life science…

Advocacy groupsCompetitivenessEuropePharmaceuticalRegulation

Spain’s Supreme Court opines on Pfizer dual pricing contracts

Spain’s Supreme Court opines on Pfizer dual pricing contracts

15-12-2014

The Spanish Supreme Court has reviewed a ruling adopted by the Audiencia Nacional, itself annulling a…

EuropeLegalPfizerPharmaceuticalPricingSpain

GlaxoSmithKline files for EU extended indication for Volibris in PAH

GlaxoSmithKline files for EU extended indication for Volibris in PAH

11-12-2014

UK pharma major GlaxoSmithKline says it has filed a regulatory submission to the European Medicines Agency…

EuropeGilead SciencesGlaxoSmithKlineLetairisPharmaceuticalRegulationRespiratory and PulmonaryVolibris

New EU Internal Market and Industry Commissioner says parallel trade is lawful

New EU Internal Market and Industry Commissioner says parallel trade is lawful

10-12-2014

In September Enrico Gasbarra, a newly-elected Italian Member of the European Parliament (BEP) from the…

EuropeMarkets & MarketingPharmaceuticalPharmaceutical sciencesPolitics

AstraZeneca’s Moventig gains EU approval for OIC

09-12-2014

The European Commission has granted marketing authorization for Anglo-Swedish pharma major AstraZeneca’s…

AstraZenecaEuropeGastro-intestinalsMoventigNektar TherapeuticsPharmaceuticalRegulation

Europe’s research and generic/biosimilar industries join forces against counterfeiting

Europe’s research and generic/biosimilar industries join forces against counterfeiting

09-12-2014

Trade groups the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European…

ESMEuropeGenericsMarkets & MarketingPharmaceutical

EFPIA responds to European Commission's patent settlement report with own transparency proposal

EFPIA responds to European Commission's patent settlement report with own transparency proposal

08-12-2014

The European Commission has published its fifth Monitoring Report of Patent Settlements in the pharma…

EuropeEuropean CommissionLegalPharmaceuticalRegulation

Bayer files for European approval of hemophilia A drug BAY 81-8973

06-12-2014

German pharma major Bayer has filed an application for marketing authorization to the European Medicines…

BAY 81-8973BayerEuropeHematologyPharmaceuticalRegulation

EMA update on review of studies performed at GVK Biosciences site in Hyderabad, India

06-12-2014

Some European Union member states have decided to suspend the marketing authorizations of medicines that…

EuropeGVK BiosciencesIndiaPharmaceuticalRegulationResearch

Turning a constraint into an enabler: transparency round-table at Veeva's commercial summit 2014

Turning a constraint into an enabler: transparency round-table at Veeva's commercial summit 2014

05-12-2014

In one of the opening sessions, cloud-based life sciences provider Veeva’s co-founder and president…

BMI SystemEuropeInterviewsPharmaceuticalRegulationVeeva

GlaxoSmithKline abandons plans to divest Established Products portfolio

05-12-2014

In what has come as something of a surprise, UK pharma major GlaxoSmithKline has abandoned its plan to…

EuropeGlaxoSmithKlineMergers & AcquisitionsNorth AmericaPharmaceutical

EMA committee concludes no evidence Fluad caused deaths

EMA committee concludes no evidence Fluad caused deaths

04-12-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that…

EuropeFluadNovartisPharmaceuticalRegulationVaccines

Age-related macular degeneration treatment market to reach $10 billion by 2023

Age-related macular degeneration treatment market to reach $10 billion by 2023

04-12-2014

The market for treatments of age-related macular degeneration across seven major countries will almost…

AvastinEuropeEyleaFovistaLucentisMarkets & MarketingOphthalmicsPharmaceuticalUSA

Astellas Xtandi approved in Europe for new indication; Janssen deal update

03-12-2014

Japanese pharma major Astellas Pharma has received European Commission approval for a variation to amend…

Anti-Arthritics/RheumaticsASP015KAstellas PharmaEuropeJanssen BiotechJohnson & JohnsonLicensingMedivationOncologyPharmaceuticalRegulationXtandi

Actelion submits selexipag for EMA marketing authorization in PAH

Actelion submits selexipag for EMA marketing authorization in PAH

03-12-2014

Swiss biotech firm Actelion has submitted a centralized Marketing Authorization Application to the European…

ActelionCardio-vascularEuropePharmaceuticalRegulationselexipag

Urgent action needed to address Clostridium difficile infections in Europe

Urgent action needed to address Clostridium difficile infections in Europe

03-12-2014

Urgent action is needed to address the current issues relating to the management of health care-acquired…

Antibiotics and Infectious diseasesEuropeEuropean ParliamentPharmaceuticalPolitics

EMA considers next steps after annulment of Guido Rasi appointment

03-12-2014

The management board of the European Medicines Agency held an extraordinary meeting last month in Rome,…

EuropeManagementPharmaceutical

Janssen and Pharmacyclics submit EMA application to expand indication for Imbruvica

Janssen and Pharmacyclics submit EMA application to expand indication for Imbruvica

01-12-2014

US health care giant Johnson & Johnson’s Belgium-based subsidiary Janssen-Cilag International has submitted…

EuropeImbruvicaJanssen-CilagOncologyPharmaceuticalPharmacyclicsRegulation

Boehringer’s Vargatef gains approval in EU for lung cancer

Boehringer’s Vargatef gains approval in EU for lung cancer

28-11-2014

The European Commission has granted EU marketing authorization for German family-owned pharma major Boehringer…

Boehringer IngelheimEuropeOncologyPharmaceuticalRegulationVargatef

Novartis’ heart failure drug LCZ696 granted accelerated assessment by CHMP

Novartis’ heart failure drug LCZ696 granted accelerated assessment by CHMP

28-11-2014

Swiss drug major Novartis announced that the European Medicines Agency’s Committee for Medicinal Products…

Cardio-vascularEuropeLCZ696NovartisPharmaceuticalRegulation

Asthma drug market set to grow $23 billion by 2023

28-11-2014

The asthma treatment market value will grow across eight major countries (the USA, UK, France, Germany,…

AdvairAstraZenecaAustraliaEuropeGlaxoSmithKlineJapanMarkets & MarketingMerck & CoPharmaceuticalRespiratory and PulmonarySingulairSymbicortUSA

UK behind European average in companies' ability to protect sensitive information

UK behind European average in companies' ability to protect sensitive information

26-11-2014

The UK is lagging behind other European companies in terms of protecting sensitive information, responding…

EuropeIron MountainLegalPharmaceuticalUnited Kingdom

Eli Lilly's Trulicity approved in the EU for type 2 diabetes

Eli Lilly's Trulicity approved in the EU for type 2 diabetes

26-11-2014

US drug major Eli Lilly has received approval from the European Commission for its GLP-1 receptor agonist…

DiabetesEli LillyEuropePharmaceuticalRegulationTrulicity

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