Regulation

Filter

Current filters:

None

Popular Filters

1 to 25 of 2586 results

New EMA guidance on EU periodic-safety-update-report single assessment for nationally authorized medicines

01-09-2014

The European Medicines Agency has updated its procedural guidance to ensure that marketing-authorization…

EuropePharmaceuticalRegulation

FDA backs added use for UCB’s Vimpat

01-09-2014

Belgium’s largest drugmaker UCB said today that the US Food and Drug Administration has approved a…

NeurologicalPharmaceuticalRegulationUCBUSAVimpat

Thrombogenics gets Spanish reimbursement approval for Jetrea

Thrombogenics gets Spanish reimbursement approval for Jetrea

01-09-2014

Ophthalmic specialist ThromboGenics has received reimbursement in Spain from the Spanish Ministry of…

AlconJetreaNon-steroidal anti-inflammatory drugsOphthalmicsPharmaceuticalRegulationSpainThromboGenics

Vifor reports positive results from Ferinject study for chronic heart failure

Vifor reports positive results from Ferinject study for chronic heart failure

01-09-2014

Switzerland-based iron specialist Vifor Pharma says its Ferinject (ferric carboxymaltose) has met its…

Cardio-vascularChronic heart failureFerinjectPharmaceuticalRegulationSwitzerlandVifor Pharma

Novartis' investigational heart failure drug LCZ696 shows striking efficacy

Novartis' investigational heart failure drug LCZ696 shows striking efficacy

31-08-2014

Swiss drug major Novartis on Saturday presented striking new data for its LZC696 heart drug at the European…

Cardio-vascularLCZ696NovartisPharmaceuticalRegulationResearch

FTC puts conditions on acquisition of Insight Pharma by Prestige Brands

29-08-2014

US firm Prestige Brands Holdings, the maker of Dramamine (dimenhydrinate), has agreed to divest assets…

Insight PharmaceuticalsMergers & AcquisitionsPharmaceuticalPrestige BrandsRegulationUSA

FDA approves Elelyso for pediatric use in Gaucher disease

FDA approves Elelyso for pediatric use in Gaucher disease

29-08-2014

The US Food and Drug Administration has approved US pharma giant Pfizer’s Elelyso (taliglucerase alfa)…

ElelysoPfizerPharmaceuticalProtalix BioTherapeuticsRare diseasesRegulationUSA

Amgen files for US approval of cholesterol drug evolocumab

28-08-2014

USA-based Amgen, the world's leading independent biotech firm, has filed a Biologics License Application…

AmgenBiotechnologyCardio-vascularevolocumabRegulationUSA

Curious resilience of the $50,000-per-QALY threshold

28-08-2014

For more than two decades, the ratio of $50,000 per quality-adjusted life-year (QALY) gained by using…

HealthcarePharmaceuticalPricingRegulationUSA

Green Cross Neulapeg biosimilar approved in South Korea

28-08-2014

South Korea’s Green Cross says that the country’s Ministry of Food and Drug Safety has granted marketing…

AmgenAsia-PacificBiosimilarsBiotechnologyGreen CrossNeulapegNeulastaOncologyRegulation

NHS England boosts the Cancer Drugs Fund for more access to innovative medicines

NHS England boosts the Cancer Drugs Fund for more access to innovative medicines

28-08-2014

The National Health Service England has pledged to boost the Cancer Drugs Fund by £160 million ($265…

Cancer Drugs FundNHS EnglandOncologyPharmaceuticalRegulationUK

UK NICE wants more info on type 2 diabetes drug Jardiance

UK NICE wants more info on type 2 diabetes drug Jardiance

28-08-2014

In a new draft guidance issued today, the UK drugs watchdog the National Institute for Health and Care…

Boehringer IngelheimDiabetesEli LillyJardiancePharmaceuticalPricingRegulationUK

Bristol-Myers’ hep C drug Daklinza approved in Europe

Bristol-Myers’ hep C drug Daklinza approved in Europe

27-08-2014

US pharma major Bristol-Myers Squibb says that the European Commission has approved Daklinza (daclatasvir),…

Anti-viralsBristol-Myers SquibbDaklinzaEuropeGilead SciencesPharmaceuticalRegulationSovaldi

FDA priority review for Amgen’s ivabradine in CHF

FDA priority review for Amgen’s ivabradine in CHF

27-08-2014

The US Food and Drug Administration has granted priority review designation for US biotech giant Amgen’s…

AmgenBiotechnologyCardio-vascularivabradineRegulationServierUSA

NICE recommends Biogen Idec’s Tecfidera for multiple sclerosis

NICE recommends Biogen Idec’s Tecfidera for multiple sclerosis

27-08-2014

The UK’s drugs watch dog, the National Institute for Health and Care Excellence (NICE), has recommended…

Biogen IdecBiotechnologyCNS DiseasesMultiple sclerosisRegulationTecfideraUK

FDA backs added indication for GSK’s Promacta

FDA backs added indication for GSK’s Promacta

27-08-2014

The Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s supplemental New Drug…

GlaxoSmithKlineHematologyLigand PharmaceuticalsPharmaceuticalPromactaRare diseasesRegulationRevoladeUSA

Health Canada OKs Biogen Idec’s hemophilia A therapy Eloctate

Health Canada OKs Biogen Idec’s hemophilia A therapy Eloctate

26-08-2014

Canadian regulator Health Canada has approved US Biotech major Biogen Idec’s Eloctate (antihemophilic…

Biogen IdecBiotechnologyCanadaEloctateHematologyRegulationSwedish Orphan Biovitrum

Alkermes files NDA for aripiprazole lauroxil in schizophrenia

Alkermes files NDA for aripiprazole lauroxil in schizophrenia

26-08-2014

Ireland-headquartered biotech firm Alkermes has submitted a New Drug Application to the US Food and Drug…

AbilifyAlkermesaripiprazole lauroxilBiotechnologyNeurologicalRegulationUSA

ViiV Healthcare gains FDA approval for HIV drug Triumeq

ViiV Healthcare gains FDA approval for HIV drug Triumeq

23-08-2014

The US Food and Drug Administration has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine…

Anti-viralsGlaxoSmithKlinePfizerPharmaceuticalRegulationShionogiTriumeqUSAViiV Healthcare

Actavis confirms patent challenge for generic Neupro

Actavis confirms patent challenge for generic Neupro

23-08-2014

Ireland-headquartered generics major Actavis on Friday confirmed that it has filed an Abbreviated New…

ActavisGenericsLegalNeuproNeurologicalPatentsRegulationUCBUSA

1 to 25 of 2586 results

Back to top