Regulation

Filter

Current filters:

None

Popular Filters

1 to 25 of 2691 results

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

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

1 to 25 of 2691 results

Parexel

Parexel

Back to top