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EMA says that vials of falsified Herceptin have been identified

EMA says that vials of falsified Herceptin have been identified

16-04-2014

The European Medicines Agency says it has been informed that vials of Swiss drug major Roche’s blockbuster…

EuropeHealthcareHerceptinOncologyPharmaceuticalRegulationRoche

EMA concludes inquiry into Roche infringement procedure

EMA concludes inquiry into Roche infringement procedure

14-04-2014

The European Medicines Agency says it has concluded its inquiry into alleged non-compliance with pharmacovigilance…

EuropePharmaceuticalRegulationRoche

Pharmacovigilance Risk Assessment Committee April meeting highlights

Pharmacovigilance Risk Assessment Committee April meeting highlights

11-04-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation…

Cardio-vascularEuropeMen's HealthNeurologicalPharmaceuticalRegulationRespiratory and Pulmonary

Emerging therapies for relapsed/refractory CLL/SLL expected to offer efficacy benefits

Emerging therapies for relapsed/refractory CLL/SLL expected to offer efficacy benefits

11-04-2014

The effect of a therapy on overall survival and progression-free survival are attributes that most influence…

BiotechnologyEuropeGilead SciencesidelalisibImbruvicaJohnson & JohnsonMarkets & MarketingOncologyUSA

Joint purchasing of vaccines and medicines becomes a reality in the EU

Joint purchasing of vaccines and medicines becomes a reality in the EU

10-04-2014

The European Commission today approved a Joint Procurement Agreement, which will enable all European…

Antibiotics and Infectious diseasesEuropeFinancialMarkets & MarketingPharmaceuticalVaccines

EGA president seeks partnership with Italian government on generics and biosimilars

09-04-2014

The president of the European Generic Medicines Association (EGA), Nick Haggar, attended the Stati Generali…

BiosimilarsEuropeGenericsItalyMarkets & MarketingPolitics

EMA plans targeted discussions on clinical trial data policy

EMA plans targeted discussions on clinical trial data policy

09-04-2014

The European Medicines Agency will launch a final round of targeted consultations with key stakeholders…

EuropePharmaceuticalRegulationResearch

US/EU generic industries call for thoughtful changes to speed medicines to patients

US/EU generic industries call for thoughtful changes to speed medicines to patients

08-04-2014

In a joint letter sent to the European Commission and the Office of the US Trade Representative, the…

EuropeGenericsPoliticsRegulationUSA

EGA Biosimilars: Prescribers must be encouraged to use biosimilars

EGA Biosimilars: Prescribers must be encouraged to use biosimilars

07-04-2014

Uptake of biosimilars in Europe has increased as a result of member states’ policies, according to…

BiosimilarsEuropeFilgrastimInterviewsMarkets & MarketingRegulationSandoz

Almirall gains European rights to InDex Pharma’s Kappaproct

07-04-2014

Sweden’s InDex Pharmaceuticals and Spain’s largest drugmaker Almirall have signed a license agreement…

AlmirallEuropeGastro-intestinalsInDex PharmaceuticalsKappaproctLicensingPharmaceutical

EGA Biosimilars: European monitoring and global business opportunities

EGA Biosimilars: European monitoring and global business opportunities

07-04-2014

The spotlight was on the European uptake of biosimilars at the European Generic medicines Association’s…

BiosimilarsEuropeGlobalInterviewsMarkets & Marketing

EMA and Australia’s TGA collaborate in the area of orphan medicines

EMA and Australia’s TGA collaborate in the area of orphan medicines

07-04-2014

During a meeting last week at the European Medicines Agency, the EMA’s executive director, Guido Rasi,…

AustraliaEuropePharmaceuticalRare diseasesRegulation

EGA Biosimilars: Call for regulatory authorities to improve awareness of biosimilars

EGA Biosimilars: Call for regulatory authorities to improve awareness of biosimilars

04-04-2014

Clear and unbiased information on biosimilars is needed to increase uptake of the medicines across Europe,…

BiosimilarsEurope

EMA confirms AbbVie’s withdrawal of court cases on access to clinical-trial data

04-04-2014

The European Medicines Agency confirms that US drugmaker AbbVie has withdrawn both its court cases brought…

AbbVieEuropeLegalPharmaceuticalResearch

EFPIA calls for collaboration in the implementation of Clinical Trials Regulation

03-04-2014

The global market for clinical trials is becoming increasingly competitive and Europe runs the risk of…

EuropePharmaceuticalRegulationResearch

Astellas files for wider use of prostate cancer drug Xtandi in Europe

03-04-2014

Japanese drug major Astellas Pharma has submitted a variation to amend the Marketing Authorization Application…

Astellas PharmaEuropeMedivationOncologyPharmaceuticalRegulationXtandi

MEPs vote for more transparent and simpler European clinical trial rules

03-04-2014

Pharmaceutical companies and academic researchers will have to post the results of all their European…

EuropePharmaceuticalRegulationResearch

European generic drug makers sets out priorities for EU Trade Policy

European generic drug makers sets out priorities for EU Trade Policy

02-04-2014

European Generic Medicines Association (EGA) revealed this morning that its president, Nick Haggar, has…

EuropeGenericsPoliticsRegulationRest of the World

Pancreatic cancer drug market in 6 major markets to see CAGR of 25% to 2017

Pancreatic cancer drug market in 6 major markets to see CAGR of 25% to 2017

01-04-2014

The global pancreatic cancer treatment market value in the six major countries (6MM: the USA, France,…

AbraxaneBiotechnologyCelgeneEuropeMarkets & MarketingOncologyUSA

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