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Canada and Europe sometimes years slower than USA in approving cancer

29-09-2014

Access to potentially life-extending cancer drugs varies significantly in different regions of the world,…

CanadaEastern EuropeEuropeOncologyPharmaceuticalRegulationUSA

Update: Negotiations on EU-Canada Free Trade Agreement concluded

29-09-2014

Canadian trade group Research-Based Pharmaceutical Companies (Rx&D) expressed its support to the government…

CanadaEuropeGenericsMarkets & MarketingPatentsPoliticsRegulation

EMA committee launches pilot project to consult patients on benefits and risk of medicines

EMA committee launches pilot project to consult patients on benefits and risk of medicines

26-09-2014

The European Medicines Agency has launched a pilot project to involve patients in the assessment of the…

Committee for Medicine Products for Human UseEuropeEuropean Medicines AgencyPharmaceuticalRegulation

Almirall’s aclidinium bromide/formoterol backed by EMA/CHMP to treat COPD

Almirall’s aclidinium bromide/formoterol backed by EMA/CHMP to treat COPD

26-09-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a…

aclidiniumAlmirallAstraZenecaBrimica GenuairDuaklir GenuairEuropeformoterolPharmaceuticalRegulationRespiratory and Pulmonary

Europe’s regulatory system for medicines can be used more effectively

Europe’s regulatory system for medicines can be used more effectively

22-09-2014

A new report from Escher, the independent TI Pharma platform for regulatory innovation, shows that the…

Andre BroekmansEuropePharmaceuticalPharmacologyRegulation

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

EFPIA wants to put an end to the resale of stolen and counterfeit drugs

EFPIA wants to put an end to the resale of stolen and counterfeit drugs

15-09-2014

The pan-European medicines verification system that the European Federation of Pharmaceutical Industries…

EuropeLegitimate supply chainMarkets & MarketingPharmaceuticalRegulation

EMA’s PRAC concludes review of Valdoxan/Thymanax

EMA’s PRAC concludes review of Valdoxan/Thymanax

14-09-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has concluded its regular…

EuropeNeurologicalPharmaceuticalRegulationServierThymanaxValdoxan

Further guidance on adaptive licensing pilot project available from EMA

12-09-2014

Based on the initial experience gained from its adaptive licensing pilot project, the European Medicines…

EuropePharmaceuticalRegulation

HAI takes issue with move of pharma policy to DG Enterprise and Industry

HAI takes issue with move of pharma policy to DG Enterprise and Industry

12-09-2014

Consumer advocacy group Health Action International says it is “appalled” by the European Commission’s…

EuropePharmaceuticalPoliticsRegulationResearch

EU approval for Boehringer and Lilly’s insulin glargine biosimilar

EU approval for Boehringer and Lilly’s insulin glargine biosimilar

10-09-2014

The European Commission granted marketing authorization for US drug major Eli Lilly and family-owned…

AbasriaBasaglarBiosimilarsBoehringer IngelheimDiabetesEli LillyEuropeInsulinLantusPharmaceuticalRegulationSanofi

Roche’s RoActemra gains EU approval for use in early RA

Roche’s RoActemra gains EU approval for use in early RA

08-09-2014

The European Commission has approved Swiss pharma major Roche’s RoActemra (tocilizumab) for use in…

ActemraAnti-Arthritics/RheumaticsEuropeInterleukin 6PharmaceuticalRegulationRoActemraRoche

EU marketing authorization for ViiV Healthcare HIV drug Triumeq

EU marketing authorization for ViiV Healthcare HIV drug Triumeq

03-09-2014

The European Commission has granted marketing authorization for ViiV Healthcare’s Triumeq (dolutegravir…

Anti-viralsEuropeGlaxoSmithKlinePharmaceuticalRegulationTriumeqViiV Healthcare

Prosonix’ generic version of GSK’s Flixotide Evohaler under review in EU

Prosonix’ generic version of GSK’s Flixotide Evohaler under review in EU

02-09-2014

UK-based Prosonix, a speciality pharmaceutical company developing a portfolio of inhaled respiratory…

EuropeEvohalerFinancialFluticasone PropionateGenericsGlaxoSmithKlineMylanProsonixRegulationRespiratory and Pulmonary

Allergan’s Ozurdex approved for DME in Europe

Allergan’s Ozurdex approved for DME in Europe

02-09-2014

Allergan revealed today that the European Commission has extended the marketing authorization for Ozurdex…

AllerganEuropeOphthalmicsOzurdexPharmaceuticalRegulation

New EMA guidance on EU periodic-safety-update-report single assessment for nationally authorized medicines

01-09-2014

The European Medicines Agency has updated its procedural guidance to ensure that marketing-authorization…

EuropePharmaceuticalRegulation

Bristol-Myers’ hep C drug Daklinza approved in Europe

Bristol-Myers’ hep C drug Daklinza approved in Europe

27-08-2014

US pharma major Bristol-Myers Squibb says that the European Commission has approved Daklinza (daclatasvir),…

Anti-viralsBristol-Myers SquibbDaklinzaEuropeGilead SciencesPharmaceuticalRegulationSovaldi

European Public Health Alliance urges European Commission to support new drugs to market

European Public Health Alliance urges European Commission to support new drugs to market

22-08-2014

The European Public Health Alliance has said it welcomes the European Commission’s proposal to improve…

EuropeEuropean CommissionEuropean Public Health AllianceHealth Medical PharmaHealth promotionHealth systemsMedicineRegulation

Eisai files for US and EU approval of lenvatinib for hard to treat thyroid cancer

Eisai files for US and EU approval of lenvatinib for hard to treat thyroid cancer

18-08-2014

Japanese pharma major Eisai has filed applications with the US Food and Drug Administration and the European…

DonepezilEisaiEuropelenvatinibOncologyPharmaceuticalRegulationUSA

Alexza updates on the five post-EMA approval studies for Adasuve

Alexza updates on the five post-EMA approval studies for Adasuve

14-08-2014

US drugmaker Alexza Pharmaceuticals has provided an update on its European Medicines Agency post-approval…

AdasuveAlexza PharmaceuticalEuropeNeurologicalPharmaceuticalPiperazinesPsychiatryRegulationResearch

Eylea approved for diabetic macular edema in Europe

Eylea approved for diabetic macular edema in Europe

11-08-2014

The European Commission has approved German pharma major Bayer’s Eylea (aflibercept) injection for…

BayerEuropeEyleaOphthalmicsOphthalmologyPharmaceuticalRegeneronRegulation

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