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EMA recommends suspending medicines over flawed studies at GVK Biosciences

EMA recommends suspending medicines over flawed studies at GVK Biosciences

23-01-2015

A number of medicines for which authorization in the European Union was primarily based on clinical studies…

EuropeGVK BiosciencesIndiaPharmaceuticalRegulationResearch

US Senator plans legislation to advance medical research

23-01-2015

In remarks at the Families USA Health Action Conference in Washington DC on January 22, US Senator Elizabeth…

FinancialLegalPharmaceuticalResearchUSA

Array acquires worldwide rights to encorafenib from Novartis

Array acquires worldwide rights to encorafenib from Novartis

23-01-2015

Oncology specialist Array Biopharma has reached an agreement with Swiss drug major Novartis to acquire…

Array BioPharmaencorafenibLicensingNovartisOncologyPharmaceutical

More EMA/CHMP recommendations

23-01-2015

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval…

Anti-viralsAntibiotics and Infectious diseasesCubistDutrebisEuropeIkervisMerck & CoOphthalmicsPharmaceuticalSanten PharmaceuticalsSivextro

Eric Halioua steps down as chief executive of Promethera Biosciences

Eric Halioua steps down as chief executive of Promethera Biosciences

23-01-2015

Belgian pharma company Promethera Biosciences has announced the resignation of its chief executive Eric…

BelgiumBoardroomEric HaliouaPharmaceuticalPromethera Biosciences

FDA's anti-infective committee recommends Astellas' Cresemba

FDA's anti-infective committee recommends Astellas' Cresemba

23-01-2015

The US Food and Drug Administration’s Anti-Infective Drugs Advisory Committee has voted unanimously…

Antibiotics and Infectious diseasesAstellasCresembaPharmaceuticalRegulationUSA

German Federal Joint Committee confirms 'considerable' benefit of Eisai's Halaven in breast cancer

German Federal Joint Committee confirms 'considerable' benefit of Eisai's Halaven in breast cancer

23-01-2015

The German Federal Joint Committee has confirmed the ‘considerable’ additional benefit of Japanese…

EisaiGermanyHalavenOncologyPharmaceuticalRegulation

CHMP adopts positive opinion on expanding indication for Pfizer's Prevenar 13

CHMP adopts positive opinion on expanding indication for Pfizer's Prevenar 13

23-01-2015

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive…

PfizerPharmaceuticalPrevenarRegulationRespiratory and Pulmonary

High hopes for President Obama’s Indian visit for pharma

High hopes for President Obama’s Indian visit for pharma

23-01-2015

This January 26, India's Republic Day is set to be a momentous one with the country hosting the US President…

IndiaPatentsPharmaceuticalPoliticsUSA

Milestone for GSK/NIH candidate Ebola vaccine as first doses shipped for Phase III trial

Milestone for GSK/NIH candidate Ebola vaccine as first doses shipped for Phase III trial

23-01-2015

UK pharma major GlaxoSmithKline said this morning that the first batch of its candidate Ebola vaccine…

EbolaGlaxoSmithKlinePharmaceuticalResearchUKVaccines

Leading Russian drug producers call for state support measures

Leading Russian drug producers call for state support measures

23-01-2015

Leading Russian drug producers have called on the national parliament (State Duma) for a complex of measures…

BiotecFinancialPharmaceuticalPolisanPricingProductionRussia

Ukraine drug imports declined by almost 30% in 2014

Ukraine drug imports declined by almost 30% in 2014

23-01-2015

Drug imports to Ukraine in 2014 decreased by almost 30%, compared to 2013, according to the Ukrainian…

FinancialKievan Rus'Markets & MarketingPharmaceuticalUkraine

Novo Nordisk gets positive opinion for Saxenda from EMA’s CHMP

Novo Nordisk gets positive opinion for Saxenda from EMA’s CHMP

23-01-2015

Danish diabetes care giant Novo Nordisk revealed yesterday that the European Medicines Agency’s Committee…

DiabetesEuropeMetabolicsNovo NordiskPharmaceuticalRegulationSaxenda

UK’s NICE backs Bayer’s Xarelto for reducing risk of secondary events in ACS

UK’s NICE backs Bayer’s Xarelto for reducing risk of secondary events in ACS

23-01-2015

The National Institute for Health and Care Excellence (NICE), the health costs watchdog for England,…

BayerCardio-vascularPharmaceuticalPricingRegulationUKXarelto

NICE set to recommend Boehringer’s type 2 diabetes drug Jardiance

NICE set to recommend Boehringer’s type 2 diabetes drug Jardiance

22-01-2015

England’s health care costs watchdog the National Institute for Health and Care Excellence (NICE) has…

Boehringer IngelheimDiabetesJardiancePharmaceuticalPricingRegulationUK

EMA publishes guide for pharma companies to support new medicines monitoring standard

EMA publishes guide for pharma companies to support new medicines monitoring standard

22-01-2015

The European Medicines Agency has published its guide to support the implementation of a new international…

EMAEuropeEuropean Medicines AgencyPharmaceuticalRegulation

Moderate growth forecast for colorectal cancer drug market

22-01-2015

The value of the colorectal cancer (CRC) therapeutics market will increase moderately, from $8.3 billion…

AvastinBayerBristol-Myers SquibbErbituxGlobalMarkets & MarketingMerck KGaAOncologyPharmaceuticalRocheStivarga

Merck & Co drops marketing of hepatitis C drug Victrelis in USA

Merck & Co drops marketing of hepatitis C drug Victrelis in USA

22-01-2015

In an open letter to pharmacy professions, US pharma giant Merck & Co has advised that it is voluntarily…

Anti-viralsMarkets & MarketingMerck & CoPharmaceuticalUSAVictrelis

AstraZeneca files marketing authorization application with EMA for lesinurad

AstraZeneca files marketing authorization application with EMA for lesinurad

22-01-2015

The European Medicines Agency has accepted the marketing authorization application by AstraZeneca for…

AstraZenecaGastro-intestinalslesinuradPharmaceuticalRegulation

IQWiG reports negative views on Provenge, Velphoro and Zydelig

IQWiG reports negative views on Provenge, Velphoro and Zydelig

22-01-2015

The German Institute for Quality and Efficiency in Health Care (IQWiG) has reviewed a number of dossiers…

DendreonGermanyGilead SciencesNephrology and HepatologyOncologyPharmaceuticalPricingProvengeRegulationVelphoroVifor PharmaZydelig

Ablynx successfully opposes Domantis' European patent appeal

Ablynx successfully opposes Domantis' European patent appeal

22-01-2015

Belgian drug developer Ablynx has successfully opposed the appeal lodged by Domantis over its European…

AblynxEuropeGSKLegalPharmaceutical

US and EU regulatory filings for UCB’s antiepileptic brivaracetam

US and EU regulatory filings for UCB’s antiepileptic brivaracetam

21-01-2015

Belgium’s largest pharma company UCB today announced regulatory filings in the USA and the European…

BRIVARACETAMEuropeNeurologicalPharmaceuticalRegulationUCBUSA

EMA launches public consultation on clinical trial transparency proposals

EMA launches public consultation on clinical trial transparency proposals

21-01-2015

The European Medicines Agency has launched a public consultation on how the transparency rules of the…

Clinical researchEuropeEuropean UnionPharmaceuticalRegulation

Supreme Court reverses Federal Circuit Court judgment on '808 patent in Teva's Copaxone

Supreme Court reverses Federal Circuit Court judgment on '808 patent in Teva's Copaxone

21-01-2015

The US Supreme Court has reversed the Federal Circuit Court’s judgment on Israel-based Teva Pharmaceutical…

CopaxoneLegalNeurologicalPharmaceuticalTevaUSA

1 to 25 of 7190 results

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