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In a new draft guidance issued today, the UK drugs watchdog the National Institute for Health and Care…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

US DEA publishes final rule to reschedule hydrocodone combination products

US DEA publishes final rule to reschedule hydrocodone combination products

22-08-2014

The US Drug Enforcement Administration (DEA) has today published in the Federal Register the Final Rule…

AnalgesiaPharmaceuticalRegulationUS Drug Enforcement AdministrationUSA

FDA expands indication for Eliquis to treatment of DVT and PE

FDA expands indication for Eliquis to treatment of DVT and PE

22-08-2014

US pharma majors Bristol-Myers Squibb and Pfizer late yesterday said that the US Food and Drug Administration…

Boehringer IngelheimCardio-vascularEliquisPfizerPharmaceuticalPulmonary embolismRegulationUSA

Lilly’s ixekizumab shows superiority over etanercept and placebo in Ph III

Lilly’s ixekizumab shows superiority over etanercept and placebo in Ph III

21-08-2014

US pharma major Eli Lilly’s investigational medicine ixekizumab was superior to etanercept and placebo…

Eli LillyInflammatory diseasesixekizumabPharmaceuticalRegulationResearch

Positive top-line Ph III results for Baxter’s BAX 855 in hemophilia A

Positive top-line Ph III results for Baxter’s BAX 855 in hemophilia A

21-08-2014

US drugmaker Baxter International has announced positive results from its Phase III pivotal clinical…

AdvateBAX 855Baxter InternationalHematologyPharmaceuticalRegulationResearch

Positive Ph III data for Amicus’ migalastat as Fabry monotherapy

Positive Ph III data for Amicus’ migalastat as Fabry monotherapy

21-08-2014

US biopharma company Amicus Therapeutics has revealed positive 18-month data from its second Phase III…

Amicus TherapeuticsBiotechnologymigalastatRare diseasesRegulationResearch

Public Citizen expert slams aspects of FDA draft drug labeling guidance

Public Citizen expert slams aspects of FDA draft drug labeling guidance

21-08-2014

The US Food and Drug Administration recently issued draft guidance that would let the pharmaceutical…

PharmaceuticalRegulationUSA

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