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EMA unit backs new hep C drugs Exviera and Viekirax from AbbVie

21-11-2014

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

AbbVieAnti-viralsEuropeExvieraPharmaceuticalRegulationViekirax

CHMP grants positive opinion to Sanofi/Genzyme's Cerdelga in Gaucher disease

CHMP grants positive opinion to Sanofi/Genzyme's Cerdelga in Gaucher disease

21-11-2014

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued…

CerdelgaEuropeGenzymePharmaceuticalRegulationSanofi

CHMP positive opinion on Victoza in type 2 diabetes patients with moderate renal impairment

CHMP positive opinion on Victoza in type 2 diabetes patients with moderate renal impairment

21-11-2014

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

DiabetesEuropeNovo NordiskPharmaceuticalRegulationVictoza

EMA makes recommendation for reducing heart attack risk of Servier's Corlentor/Procoralan

EMA makes recommendation for reducing heart attack risk of Servier's Corlentor/Procoralan

21-11-2014

The European Medicines Agency has reviewed angina medication Corlentor/Procoralan (ivibradine), manufactured…

Cardio-vascularEuropePharmaceuticalProcoralanRegulationServier

France negotiates lowest price in Europe for Gilead’s Sovaldi

France negotiates lowest price in Europe for Gilead’s Sovaldi

21-11-2014

The discount negotiated by the French government on hepatitis C drug Sovaldi (sofosbuvir), produced by…

FranceGilead SciencesNephrology and HepatologyPharmaceuticalPoliticsPricingRegulationSovaldi

Kissei files for Japanese approval of PA21 for hyperphosphatemia

21-11-2014

Japanese mid-sized drugmaker Kissei Pharmaceutical says that a new drug application for PA21 (development…

FreseniusJapanKissei PharmaceuticalNephrology and HepatologyPA21PharmaceuticalRegulationVelphoroVifor Pharma

Future bleak for Novartis’ panobinostat in relapsed/refractory multiple myeloma, says analyst

21-11-2014

The vote against the recommendation that the US Food and Drug Administration approves Novartis’ panobinostat…

daratumumabelotuzumabFarydakNovartisOncologypanobinostatPharmaceuticalRegulation

Novartis’ Cosentyx wins positive opinion from EMA’s CHMP

Novartis’ Cosentyx wins positive opinion from EMA’s CHMP

21-11-2014

Swiss pharma giant Novartis this morning revealed that the European Medicines Agency’s Committee for…

BiotechnologyCosentyxDermatologicalsEuropeNovartisRegulationsecukinumab

EMA revises policy on conflict of interests

20-11-2014

The European Medicines Agency has today published its revised policy on handling declarations of interests…

EuropeFinancialPharmaceuticalRegulation

UK government looks to speed up access to new medicines

UK government looks to speed up access to new medicines

20-11-2014

The UK government has announced a substantial investment package from industry, and that it is to carry…

BiotechnologyPoliticsRegulationUKUnited Kingdom

Australia and New Zealand abandon plans to form joint regulator

Australia and New Zealand abandon plans to form joint regulator

20-11-2014

The Ministers for Health from Australia and New Zealand have confirmed they are to end efforts to establish…

Asia-PacificAustraliaNew ZealandRegulationTherapeutic Goods Administration

ALK Abello files for European approval for its dust mite allergy sublingual tablets

ALK Abello files for European approval for its dust mite allergy sublingual tablets

20-11-2014

Denmark-based allergy specialist ALK Abello has filed a registration application for its house dust mite…

ALK AbelloDenmarkImmunologicalsPharmaceuticalRegulation

HHS and NIH take steps to enhance clinical trial results transparency

20-11-2014

The US Department of Health and Human Services today issued a Notice of Proposed Rulemaking (NPRM), which…

PharmaceuticalRegulationResearchUSA

Sanofi and Regeneron’s dupilumab gets Breakthrough designation from FDA

20-11-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to French pharma major…

BiotechnologyDermatologicalsdupilumabRegeneronRegulationSanofiUSA

Added benefit of Jardiance not proven, says IQWiG

19-11-2014

Following an examination as to whether Jardiance (empagliflozin) offers an added benefit over appropriate…

Boehringer IngelheimDiabetesEli LillyGermanyJardiancePharmaceuticalPricingRegulation

NICE seeks more information on Xolair to treat hives

19-11-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Swiss…

DermatologicalsNovartisPharmaceuticalPricingRegulationUKXolair

Gilead Sciences’ Harvoni gains EU approval

Gilead Sciences’ Harvoni gains EU approval

19-11-2014

The European Commission yesterday granted marketing authorization for US biotech antiviral specialists…

Anti-viralsBiotechnologyEuropeGilead SciencesHarvoniRegulationSovaldi

Stronger punishments for production and sale of fake drugs in China

18-11-2014

Chinese authorities will hand out harsher punishment for the production and sale of fake and substandard…

ChinaMarkets & MarketingPharmaceuticalProductionRegulation

Bayer/Regeneron’s Eylea approved in Japan for DME

18-11-2014

German pharma major Bayer’s Japanese subsidiary, Bayer Yakuhin, has received approval from the Ministry…

BayerBiotechnologyEyleaJapanOphthalmicsRegeneronRegulation

Russian government to start checks for GMP compliance of domestic drug producers

Russian government to start checks for GMP compliance of domestic drug producers

18-11-2014

The Russian government plans to start massive checks of the domestic producers of drugs, as well as drug…

PharmaceuticalProductionRegulationRussiaRussian government

Pharma serialization: Is our industry on the brink of a mass extinction event?

Pharma serialization: Is our industry on the brink of a mass extinction event?

18-11-2014

Former AstraZeneca serialization expert, Ian Haynes asks whether the fact that many pharma companies…

Markets & MarketingPharmaceuticalProductionRegulation

Ukrainian government to impose state control for drug prices in domestic market

Ukrainian government to impose state control for drug prices in domestic market

18-11-2014

The Ukraine government has officially imposed state control on the prices of drugs in the domestic market,…

PharmaceuticalPricingRegulationUkraineUkraine government

Internationally health economic evaluations are a fixed component of reimbursement decisions, says IQWiG

17-11-2014

Internationally health economic evaluations (HEEs) form a legally regulated fixed component in health-care…

GermanyGlobalPharmaceuticalPricingRegulation

Yet another indication for Roche’s blockbuster Avastin from FDA

16-11-2014

The US Food and Drug Administration on Friday approved Avastin (bevacizumab) solution for intravenous…

AvastinBiotechnologyEli LillyGemzarGenentechOncologyRegulationRocheUSA

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