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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

FDA at last approves Genzyme’s Lemtrada

FDA at last approves Genzyme’s Lemtrada

15-11-2014

The US Food and Drug Administration on Friday approved French pharma major Sanofi subsidiary Genzyme’s…

BayerBiotechnologyGenzymeLemtradaNeurologicalRegulationSanofiUSA

ABPI speaks out against changes to UK Cancer Drugs Fund medicines list

ABPI speaks out against changes to UK Cancer Drugs Fund medicines list

14-11-2014

The Association of the British Pharmaceutical Industry has spoken out against imminent changes to how…

NHSOncologyPharmaceuticalRegulationUK

Ethical business practices promoted by Medicines Australia singled out in APEC Declaration

Ethical business practices promoted by Medicines Australia singled out in APEC Declaration

14-11-2014

Ethical business practices promoted by industry representative Medicines Australia in Asia Pacific are…

Asia-PacificAustraliaMedicines AustraliaPharmaceuticalRegulation

EMA responds to Ombudsman questioning of AbbVie trial redactions

13-11-2014

The European Medicines Agency says it has taken note of the European Ombudsman’s recent remarks on…

AbbVieAnti-Arthritics/RheumaticsEuropeHumiraPharmaceuticalRegulationResearch

UK Cancer Drugs Fund to re-assess procedure and currently-approved drugs

UK Cancer Drugs Fund to re-assess procedure and currently-approved drugs

13-11-2014

The UK’s National Health Service has updated its procedure for evaluating drugs in the Cancer Drugs…

AvastinKadcylaOncologyPharmaceuticalRegulationSprycelUK

FDA approves sNDA for Janssen's Invega Sustenna in schizoaffective disorder

FDA approves sNDA for Janssen's Invega Sustenna in schizoaffective disorder

13-11-2014

The US Food and Drug Administration has approved the supplemental New Drug Applications (sNDAs) from…

Invega SustennaJanssenNeurologicalPharmaceuticalRegulationUSA

Actavis' sNDA accepted by FDA for Saphris in bipolar I disorder

Actavis' sNDA accepted by FDA for Saphris in bipolar I disorder

13-11-2014

Ireland-headquartered generics major Actavis has had its Supplemental New Drug Application for Saphris…

ActavisIrelandNeurologicalPharmaceuticalRegulationSaphris

Par Pharmaceuticals receives FDA approval for Vasostrict in low blood pressure

Par Pharmaceuticals receives FDA approval for Vasostrict in low blood pressure

13-11-2014

Generic and branded specialty pharma company Par Pharmaceuticals has received approval for its New Drug…

HematologyPar PharmaceuticalsPharmaceuticalRegulationUSAVasostrict

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