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Global drugmakers call for improvement of Russian pharma legislation

27-03-2015

Leading global pharmaceutical manufacturers operating in the Russian market have expressed their concerns…

FinancialPharmaceuticalProductionRegulationRussia

Slow growth forecast for Germany’s pharma market

27-03-2015

While Germany is the leading pharmaceutical market in Europe, valued at $58.6 billion in 2014, the sector…

GermanyMarkets & MarketingPharmaceuticalPricingRegulation

UPDATE: Novo Nordisk rises as it says it plans to resubmit Tresiba and Ryzodeg NDAs in USA

UPDATE: Novo Nordisk rises as it says it plans to resubmit Tresiba and Ryzodeg NDAs in USA

27-03-2015

Danish diabetes care giant Novo Nordisk has decided to submit the pre-specified interim analysis of DEVOTE…

DiabetesNovo NordiskPharmaceuticalRegulationResearchRyzodegTresibaUSA

Sanofi Pasteur’s Quadracel vaccine gets FDA approval

26-03-2015

French pharma major Sanofi’s (Euronext: SAN) Sanofi Pasteur has received approval from the US Food…

PharmaceuticalQuadracelRegulationSanofiSanofi PasteurUSAVaccines

FDA approval for Emergent BioSolutions’ Anthrasil

25-03-2015

US biopharma company Emergent BioSolutions has received approval from the US Food and Drug Administration…

AnthrasilAntibiotics and Infectious diseasesEmergent BioSolutionsPharmaceuticalRegulationUSA

European Commission approves Santen Pharma’s Ikervis for eye disease

25-03-2015

Japanese drugmaker Santen Pharmaceutical has received approval of the Marketing Authorization Application…

EuropeIkervisOphthalmicsPharmaceuticalRegulationSanten Pharmaceuticals

FDA safety review of Zyprexa Relprevv calls for no changes to current prescribing

24-03-2015

The US Food and Drug Administration has concluded a review of a study undertaken to determine the cause…

Eli LillyHealthcareNeurologicalPharmaceuticalRegulationUSAZyprexa Relprevv

Novo Nordisk’s Saxenda gains EU approval for obesity

24-03-2015

There was good news for Danish diabetes care giant Novo Nordisk yesterday, when, late in the day, the…

DiabetesEuropeMetabolicsNovo NordiskPharmaceuticalRegulationSaxendaVictoza

Pfizer and Lilly gear up to resume Phase III chronic pain program for tanezumab

23-03-2015

US pharma majors Pfizer and Eli Lilly both saw their shares rise in pre-market trading today, as they…

Eli LillyLicensingNeurologicalPfizerPharmaceuticalRegulationUSA

Ukranian pharma organization APRaD meets with European bodies on domestic health reform

Ukranian pharma organization APRaD meets with European bodies on domestic health reform

23-03-2015

The Ukrainian pharma organization, the Association of Pharmaceutical Research and Development (APRaD)…

BrusselsPharmaceuticalPoliticsRegulationUkraine

Dilaforette's sevuparin granted orphan drug designation by FDA in sickle-cell disease

Dilaforette's sevuparin granted orphan drug designation by FDA in sickle-cell disease

20-03-2015

Dilaforette, a portfolio company of Karolinska Development, a Nordic investor in life sciences, has been…

DilaforetteHematologyPharmaceuticalRegulationResearchSevuparinSwedenUSA

Compliance at home and in emerging markets the key challenges to pharma, says study

Compliance at home and in emerging markets the key challenges to pharma, says study

20-03-2015

The UK pharma sector expects one of its biggest challenges to be the risk of incurring fines as they…

Markets & MarketingPharmaceuticalProductionRegulationUK

Mixed FDA advisory panel views on GSK’s Breo Ellipta

20-03-2015

There was conflicting news yesterday for UK pharma major GlaxoSmithKline and US partner Theravance from…

Breo ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and Pulmonary

Research from IQWiG shows early benefit assessment increases trial data transparency

Research from IQWiG shows early benefit assessment increases trial data transparency

18-03-2015

Research from the German Institute for Quality and Efficiency in Healthcare (IQWiG) published in the…

Efficiency in HealthcareGermanyPharmaceuticalPharmacologyRegulation

Actavis' sNDA for Saphris approved by FDA

Actavis' sNDA for Saphris approved by FDA

16-03-2015

The US Food and Drug Administration has approved the supplemental New Drug Application for Saphris (asenapine),…

ActavisNeurologicalPharmaceuticalRegulationSaphrisUSA

FDA again delays decision on Merck’s investigational drug sugammadex

14-03-2015

The US Food and Drug Administration has cancelled the meeting of the Anesthetic and Analgesic Drug Products…

Merck & CoNeurologicalPharmaceuticalRegulationsugammadexUSA

Highlights of EMA’s PRAC March meetings

13-03-2015

The European Medicines Agency has released highlights of the March 9-12 meeting of its Pharmacovigilance…

Anti-Arthritics/RheumaticscodeineEuropeNeurologicalNovartisPharmaceuticalRegulationzoledronic acid

EC backs expanded approval of Novo Nordisk’s Tresiba for children

EC backs expanded approval of Novo Nordisk’s Tresiba for children

12-03-2015

Danish diabetes care giant Novo Nordisk says that the European Commission has approved the expanded use…

DiabetesEuropeNovo NordiskPharmaceuticalRegulationTresiba

NICE recommends GSK’s Arzerra for chronic lymphocytic leukemia

NICE recommends GSK’s Arzerra for chronic lymphocytic leukemia

11-03-2015

Confirming an earlier preliminary guidance, medicines cost watchdog for England, the National Institute…

ArzerraGlaxoSmithKlineOncologyPharmaceuticalPricingRegulationUK

EMA publishes document accounting for its pharmacovigilance fees

EMA publishes document accounting for its pharmacovigilance fees

11-03-2015

The European Medicines Agency has published a document accounting for its pharmacovigilance fees.

EMAEuropeEuropean Medicines AgencyPharmaceuticalRegulation

Merck’s pembrolizumab is first drug to be made available through UK’s EAMS for advanced melanoma

Merck’s pembrolizumab is first drug to be made available through UK’s EAMS for advanced melanoma

11-03-2015

US pharma giant Merck & Co revealed yesterday that its anti-PD-1 therapy, pembrolizumab, which is marketed…

KeytrudaMarkets & MarketingMerck & CoOncologypembrolizumabPharmaceuticalRegulationUK

Eisai's Halaven to stay on UK Cancer Drugs Fund list pending reconsideration

Eisai's Halaven to stay on UK Cancer Drugs Fund list pending reconsideration

11-03-2015

Japanese drug major Eisai has announced that its drug Halaven (eribulin) will remain on the UK's National…

EisaiHalavenOncologyPharmaceuticalRegulationUK

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