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Xultophy, Accofil and Busulfan recommended by EMA/CHMP

26-07-2014

At its July 2014 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human…

AccofilAccord HealthcareBiosimilarsBusulfanDiabetesEuropeFresenius KabiImmunologicalsNovo NordiskOncologyPharmaceuticalRegulationXultophy

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

Expert View: Has UK pharma lost its Euro-vision?

Expert View: Has UK pharma lost its Euro-vision?

23-07-2014

Former AstraZeneca serialization expert, Christoph Krähenbühl, demystifies the arguments around compliance…

EuropeEuropean UnionMarkets & MarketingMedicines verification infrastructurePharmaceuticalResearchUK

Private health care market in Central Europe looks to gather momentum by 2018

Private health care market in Central Europe looks to gather momentum by 2018

21-07-2014

New data from Poland-based research company PRM is forecasting a revival of the private health care market…

Czech RepublicEuropeHungaryMarkets & MarketingPharmaceuticalPolandPrivate healthcare

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

Drug-treated hepatitis C population to more than double by 2016

Drug-treated hepatitis C population to more than double by 2016

16-07-2014

The hepatitis C virus population is already large, with 2 million diagnosed, chronically infected cases…

Anti-viralsCytokinesDaklinzaDecision Resources GroupEuropeHepatitis CInterferonJapanMarkets & MarketingPharmaceuticalUSA

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

Novartis collaborates with Banner Alzheimer's Inst on AD prevention study

Novartis collaborates with Banner Alzheimer's Inst on AD prevention study

15-07-2014

Swiss pharma major Novartis has set up a collaboration with US not-for-profit group the Banner Alzheimer's…

Active immunotherapyAlzheimer's diseaseEuropeNeurologicalNovartisNovartis PharmaceuticalsPharmaceuticalResearchUSA

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

Servier to appeal EC fine over perindopril

Servier to appeal EC fine over perindopril

11-07-2014

French privately-held drugmaker Servier has said it will appeal before the European Union Court of Justice…

Cardio-vascularEuropeFinancialLegalPerindoprilperindoprilPharmaceuticalServier

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

Glowing prospects for Novo Nordisk's insulin degludec/liraglutide for type 2 diabetes

Glowing prospects for Novo Nordisk's insulin degludec/liraglutide for type 2 diabetes

07-07-2014

Danish diabetes care giant Novo Nordisk's fixed-dose combination therapy insulin degludec/liraglutide…

DiabetesEuropeIDegLiraMarkets & MarketingNovo NordiskPharmaceuticalUSAXultophy

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

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