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Alcon’s Simbrinza approved for glaucoma in the EU

Alcon’s Simbrinza approved for glaucoma in the EU

28-07-2014

Eyecare specialist Alcon, a division of Swiss drug major Novartis, says its Simbrinza eye drops suspension…

AlconEuropeEuropean CommissionGlaucomaOphthalmicsPharmaceuticalRegulationSimbrinza

EMA’s CHMP backs approval of two new treatment options for rare cancers

EMA’s CHMP backs approval of two new treatment options for rare cancers

26-07-2014

The European Medicines Agency's Committee for Medicinal Products for Human Use, at its July meeting,…

BiotechnologyEuropeFinancialGilead SciencesImbruvicaJanssen BiotechJohnson & JohnsonOncologyRegulationZydelig

Is Europe putting cancer research at risk?

25-07-2014

The European Society for Medical Oncology (ESMO) has expressed concern that the proposed European Union…

EuropeOncologyPharmaceuticalRegulationResearch

GSK files EU regulatory submission for RTS,S malaria vaccine candidate

24-07-2014

UK pharma giant GlaxoSmithKline announced today that it has submitted a regulatory application to the…

EuropeGlaxoSmithKlinePharmaceuticalRegulationRest of the WorldRTS,STropical diseasesVaccines

Levonorgestrel and ulipristal remain suitable emergency contraceptives, says EMA

24-07-2014

The European Medicines Agency has concluded its review of emergency contraceptives containing levonorgestrel…

EuropeLevonorgestrelNorLevoPharmaceuticalRegulationReproductiveulipristalWomen's Health

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

The EMA’s scientific advice to pharma companies is a conflict of interest, says industry coalition

The EMA’s scientific advice to pharma companies is a conflict of interest, says industry coalition

15-07-2014

A coalition of major European medicines advocates has criticized the European Medicines Agency for providing…

EuropeEuropean Medicines AgencyHealth technology assessment bodiesPharmaceuticalPricingRegulation

Ariad says PRAC requires additional data on Iclusig

Ariad says PRAC requires additional data on Iclusig

15-07-2014

US specialty pharma firm Ariad Pharmaceuticals says that the Pharmacovigilance Risk Assessment Committee…

Ariad PharmaceuticalsEuropeIclusigOncologyPharmaceuticalPharmacovigilance Risk Assessment CommitteeRegulation

Highlights of EMA Pharmacovigilance committee July meeting

Highlights of EMA Pharmacovigilance committee July meeting

14-07-2014

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) concluded two safety…

bromocriptineEuropeNephrology and HepatologyNeurologicalPharmaceuticalRegulationRiensoTakeda Pharmaceuticalvalproate Sodium InjectionWomen's Health

EUCOPE slams French plans to cut spending through off-label drugs

EUCOPE slams French plans to cut spending through off-label drugs

12-07-2014

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) says it is very concerned about legislative…

AvastinEuropeFranceLegalOphthalmicsPharmaceuticalRegulationRoche

Orphan drug approvals rise, but high costs pose challenges for patients

Orphan drug approvals rise, but high costs pose challenges for patients

10-07-2014

Although the pace of approvals for new orphan drugs - medicines that treat relatively rare conditions…

EuropePharmaceuticalPricingRare diseasesRegulationUSA

EU orphan designations for OPKO's clotting Factor VIIa-CTP

EU orphan designations for OPKO's clotting Factor VIIa-CTP

10-07-2014

The European Committee for Orphan Medicinal Products (COMP) gave a positive opinion recommending the…

EuropeFactor VIIa-CTPHematologyOPKO HealthPharmaceuticalRare diseasesRegulation

EMA delays formal adoption of publication of clinical trial data policy

EMA delays formal adoption of publication of clinical trial data policy

10-07-2014

The European Medicines Agency management board has postponed formal adoption of the policy on publication…

EuropeEuropean Medicines AgencyEuropean UnionPharmaceuticalRegulationResearch

France adopts draft law on off-label use of drugs

France adopts draft law on off-label use of drugs

09-07-2014

The French National Assembly yesterday voted on the draft law proposal, which would potentially allow…

AvastinDraft law proposalEuropeFranceLegalOphthalmicsPharmaceuticalRegulationRoche

Swissmedic approves Amitiza for opioid-induced constipation

Swissmedic approves Amitiza for opioid-induced constipation

08-07-2014

US biopharma firm Sucampo Pharmaceuticals has received approval from Swissmedic, Switzerland’s Agency…

AmitizaEuropeGastro-intestinalsPharmaceuticalRegulationSucampo

AcelRx and Grunenthal file for EU approval of Zalviso

AcelRx and Grunenthal file for EU approval of Zalviso

07-07-2014

USA-based AcelRx Pharmaceuticals revealed this morning that its partner, family-owned German drugmaker…

AcelRxEuropeGrunenthalNeurologicalPharmaceuticalRegulationZalviso

GSK receives EU approval for Mekinist for melanoma

GSK receives EU approval for Mekinist for melanoma

04-07-2014

The European Commission has granted marketing authorization for UK pharma giant GlaxoSmithKline’s Mekinist…

EuropeGlaxoSmithKlineMekinistOncologyPharmaceuticalRegulation

EMA/CHMP positive opinion for Teva’s Seasonique contraceptive

EMA/CHMP positive opinion for Teva’s Seasonique contraceptive

04-07-2014

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

EuropePharmaceuticalRegulationReproductiveSeasoniqueTeva Pharmaceutical IndustriesWomen's Health

EU approval for GSK and Genmab’s Arzerra as first-line CLL therapy

EU approval for GSK and Genmab’s Arzerra as first-line CLL therapy

03-07-2014

The European Commission has granted marketing authorization for a new indication for the use of UK pharma…

ArzerraEuropeGenmabGlaxoSmithKlineOncologyPharmaceuticalRegulation

Eisai’s breast cancer drug Halaven receives MAA in Europe

Eisai’s breast cancer drug Halaven receives MAA in Europe

03-07-2014

The European Commission has issued Marketing Authorization Approval (MAA) for Halaven (eribulin) from…

EisaiEuropeHalavenOncologyPharmaceuticalRegulation

Boehringer submits tiotropium + olodaterol Respimat for European approval in COPD

Boehringer submits tiotropium + olodaterol Respimat for European approval in COPD

02-07-2014

German family-owned pharma major Boehringer Ingelheim says it has submitted Marketing Authorization Applications…

Boehringer IngelheimEuropePharmaceuticalRegulationRespiratory and Pulmonarytiotropium + olodaterol Respimat

pSivida’s marketing authorizations for Iluvien in 10 countries reaches next stage

pSivida’s marketing authorizations for Iluvien in 10 countries reaches next stage

01-07-2014

Drug delivery specialists pSivida says that the regulatory process for marketing authorizations of Iluvien…

EuropeIluvienOphthalmicsPharmaceuticalpSividaRegulation

EMA accepts Merck’s pembrolizumab MAA for review

EMA accepts Merck’s pembrolizumab MAA for review

01-07-2014

US pharma giant Merck & Co says that the European Medicines Agency has accepted for review a Marketing…

EuropeMerck & CoOncologypembrolizumabPharmaceuticalRegulation

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