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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

US FDA pushes back decision date for Novartis’ panobinostat

US FDA pushes back decision date for Novartis’ panobinostat

25-11-2014

The US Food and Drug Administration has extended its priority review period by up to three months for…

FarydakNovartisOncologypanobinostatPharmaceuticalRegulationUSA

Meaningful discussions at 9th International Summit of Heads of Medicines Regulatory Agencies

24-11-2014

Wu Zhen, Vice Minister of China Food and Drug Administration (CFDA), met with the delegates of Canada,…

BrazilCanadaChinaPharmaceuticalProductionRegulation

Beximco Pharma receives GMP approval from Health Canada

Beximco Pharma receives GMP approval from Health Canada

24-11-2014

Bangladeshi drugmaker Beximco Pharma has received Good Manufacturing Practices approval from Health Canada,…

BangladeshBeximco PharmaceuticalsCanadaGenericsProductionRegulation

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

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

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