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Boehringer’s Vargatef gains approval in EU for lung cancer

Boehringer’s Vargatef gains approval in EU for lung cancer

28-11-2014

The European Commission has granted EU marketing authorization for German family-owned pharma major Boehringer…

Boehringer IngelheimEuropeOncologyPharmaceuticalRegulationVargatef

Novartis’ heart failure drug LCZ696 granted accelerated assessment by CHMP

Novartis’ heart failure drug LCZ696 granted accelerated assessment by CHMP

28-11-2014

Swiss drug major Novartis announced that the European Medicines Agency’s Committee for Medicinal Products…

Cardio-vascularEuropeLCZ696NovartisPharmaceuticalRegulation

NICE final draft guidance recommends Soliris, but saying it is “very expensive”

NICE final draft guidance recommends Soliris, but saying it is “very expensive”

27-11-2014

The UK National Institute for Health and Care Excellence (NICE) has today issued final draft guidance…

Alexion PharmaceuticalsBiotechnologyPricingRare diseasesRegulationSolirisUK

UK uses fewer branded medicines per person than comparable countries and is still using older therapies

UK uses fewer branded medicines per person than comparable countries and is still using older therapies

27-11-2014

The Association of the British Pharmaceutical Industry has published new research showing that UK use…

ABPIMarkets & MarketingPharmaceuticalRegulationUK

FTC puts conditions on GSK/Novartis consumer JV

27-11-2014

The US Federal Trade Commission has voted to approve UK pharma giant GlaxoSmithKline’s proposed acquisition…

Dr Reddy's LaboratoriesGlaxoSmithKlineHabitrolMergers & AcquisitionsNicodermNovartisPharmaceuticalRegulationUSAVaccines

WHO's calls for more thorough clinical trial result disclosure welcomed by Germany's IQWiG

WHO's calls for more thorough clinical trial result disclosure welcomed by Germany's IQWiG

27-11-2014

The World Health Organization (WHO) has made an official statement on the disclosure of clinical trial…

GlobalHealthPharmaceuticalRegulationResearchWorld Health Organization

US FDA requests additional data for Bristol-Myers Squibb's daclatasvir

US FDA requests additional data for Bristol-Myers Squibb's daclatasvir

27-11-2014

US pharma major Bristol-Myers Squibb has received a Complete Response Letter from the US Food and Drug…

Anti-viralsBristol-Myers SquibbdaclatasvirPharmaceuticalRegulationUSA

Russia tightens procedure for accelerated registration of drugs

27-11-2014

Only the first three generics, along with generics intended for minors, as well as orphan drugs, will…

GenericsRegulationRussia

OPEN Act introduced in USA to repurpose drugs for rare diseases

OPEN Act introduced in USA to repurpose drugs for rare diseases

26-11-2014

Last week, US Representatives Gus Bilirakis (Republican, Florida) and G K Butterfield (Democrat, North…

PharmaceuticalPoliticsRare diseasesRegulationUSA

Takeda's Entyvio given provisional approval by UK's NICE

Takeda's Entyvio given provisional approval by UK's NICE

26-11-2014

The UK’s National Institute for Health and Care Excellence (NICE) has given a provisional approval…

BiotechnologyEntyvioGastro-intestinalsRegulationTakeda PharmaceuticalUK

Initiative to support and enhance medicine quality assurance in Latin American/Caribbean

Initiative to support and enhance medicine quality assurance in Latin American/Caribbean

26-11-2014

Representatives from 16 Latin American and Caribbean countries laid the foundation for a regional mechanism…

PeruPharmaceuticalRegulationSouth America

Eli Lilly's Trulicity approved in the EU for type 2 diabetes

Eli Lilly's Trulicity approved in the EU for type 2 diabetes

26-11-2014

US drug major Eli Lilly has received approval from the European Commission for its GLP-1 receptor agonist…

DiabetesEli LillyEuropePharmaceuticalRegulationTrulicity

FDA adds warning to Tecfidera label after patient death

FDA adds warning to Tecfidera label after patient death

26-11-2014

The US Food and Drug Administration has issued a warning that a patient with multiple sclerosis who was…

Biogen IdecCNS DiseasesPharmaceuticalRegulationTecfideraUSA

Strengthen IP to reposition Australia as a global leader, says Medicines Australia chief to government

Strengthen IP to reposition Australia as a global leader, says Medicines Australia chief to government

26-11-2014

The chief executive of Medicines Australia has called for a strengthening of Australia’s intellectual…

AustraliaBiotechnologyLegalMedicines AustraliaRegulationResearch

NICE updated guidance backs Novartis’ Glivec for GIST

26-11-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has issued final…

GlivecNovartisOncologyPharmaceuticalPricingRegulationUK

UK's NICE recommends Selincro to help reduce alcohol dependence

UK's NICE recommends Selincro to help reduce alcohol dependence

26-11-2014

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Selincro (nalmefene)…

LundbeckNeurologicalPharmaceuticalRegulationSelincroUK

Merck & Co submits first regulatory filing for omarigliptin, in Japan

Merck & Co submits first regulatory filing for omarigliptin, in Japan

25-11-2014

US pharma giant Merck & Co has submitted a new drug application for omarigliptin, its investigational…

DiabetesJapanMerck & CoomarigliptinPharmaceuticalRegulation

Janssen submits NDA for Yondelis in soft tissue sarcoma

Janssen submits NDA for Yondelis in soft tissue sarcoma

25-11-2014

US health care giant Johnson & Johnson’s subsidiary Janssen Research & Development has submitted a…

Janssen Research and DevelopmentOncologyPharmaceuticalRegulationUSAYondelis

Mylan confirms first-to-file patent challenge relating to Brevibloc

25-11-2014

US generic drugmaker Mylan today confirmed that it and several subsidiaries have been sued by US drugmaker…

Baxter InternationalBreviblocCardio-vascularGenericsLegalMylanPatentsRegulationUSA

Regeneron and Sanofi granted breakthrough designation for dupilumab

Regeneron and Sanofi granted breakthrough designation for dupilumab

25-11-2014

US biotech Regeneron Pharmaceuticals and French pharma major Sanofi have said that the US Food and Drug…

BiotechnologyDermatologicalsdupilumabRegeneronRegulationSanofiUSA

Russian government predicts bright prospects to national pharma industry

Russian government predicts bright prospects to national pharma industry

25-11-2014

The Russian pharmaceutical industry is booming, despite the economic recession in the country and devaluation…

Markets & MarketingPharmaceuticalPricingRegulationRussia

HIV therapy Rezolsta approved by EC

HIV therapy Rezolsta approved by EC

25-11-2014

Belgium-based Janssen-Cilag International NV, a subsidiary of US health care giant Johnson & Johnson,…

Anti-viralsEuropeJanssen-CilagPharmaceuticalPrezistaRegulation

Novartis' Signifor approved in EU for acromegaly patients

Novartis' Signifor approved in EU for acromegaly patients

25-11-2014

The European Commission has approved Swiss drug major Novartis’ Signifor (pasireotide) for patients…

NovartisPharmaceuticalRare diseasesRegulationSigniforSwitzerland

AstraZeneca’s Duaklir Genuair approved in the EU for COPD

AstraZeneca’s Duaklir Genuair approved in the EU for COPD

25-11-2014

The European Commission has granted marketing authorization for Anglo-Swedish pharma major AstraZeneca’s…

AstraZenecaDuaklir GenuairPharmaceuticalRegulationRespiratory and PulmonaryUK

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