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Biosimilars viable only for biologics with sales of $898 million, says Prime Therapeutics report

Biosimilars viable only for biologics with sales of $898 million, says Prime Therapeutics report

26-02-2015

Although there is widespread optimism around the first biosimilars being launched in the USA, a new report…

BiosimilarsProductionRegulationUnited StatesUSA

NICE recommends Sovaldi and Olysio for hepatitis C

NICE recommends Sovaldi and Olysio for hepatitis C

25-02-2015

The UK’s National Institute for Health and Care Excellence (NICE) has published final guidance recommending…

Anti-viralsGilead SciencesJanssenOlysioPharmaceuticalRegulationSovaldiUK

UK doctors call for approval of off-label use of Avastin for wet-AMD

UK doctors call for approval of off-label use of Avastin for wet-AMD

25-02-2015

Doctors in the UK are calling on health ministers and NHS England to intervene to make Swiss pharma giant…

AvastinBiotechnologyHealthcareLucentisNovartisOphthalmicsPricingRegulationRocheUK

NICE recommends Pfizer's Inlyta but not Dendreon's Provenge

NICE recommends Pfizer's Inlyta but not Dendreon's Provenge

25-02-2015

The UK’s National Institute for Health and Care Excellence has recommended Inlyta (axitinib), marketed…

DendreonInlytaOncologyPfizerPharmaceuticalPricingProvengeRegulationUKValeant Pharmaceuticals International

Federal Trade Commission puts conditions on Novartis acquisition of GSK oncology portfolio

Federal Trade Commission puts conditions on Novartis acquisition of GSK oncology portfolio

24-02-2015

The US Federal Trade Commission has put conditions on the proposed acquisition by Novartis of GlaxoSmithKline’s…

Array BioPharmaGSKLegalMergers & AcquisitionsNovartisOncologyPharmaceuticalRegulationResearchUSA

Health care is up for a revolution with the rise of personal genomic tests; report

24-02-2015

As the era of personalized medicine dawns on health care, the need to understand an individual’s genetic…

BiotechnologyGlobalRegulationResearch

US FDA approves Novartis’ Farydak, the first HDAC inhibitor for MM patients

24-02-2015

The US Food and Drug Administration yesterday approved Swiss pharma giant Novartis’ Farydak (panobinostat,…

FarydakNovartisOncologypanobinostatPharmaceuticalRegulationUSA

Eli Lilly delays US and Europe filings for new diabetes agent peglispro

23-02-2015

US pharma major Eli Lilly says it is delaying the submission of its basal insulin peglispro (BIL) to…

DiabetesEli LillyEuropepeglisproPharmaceuticalRegulationUSA

Intas becomes first Indian company to launch biosimilar in the EU

Intas becomes first Indian company to launch biosimilar in the EU

23-02-2015

Indian biopharma company Intas has become the first Indian company to launch a biosimilar in highly regulated…

BiosimilarsBiotechnologyFilgrastimHematologyImmunologicalsIndiaIntas PharmaceuticalsMarkets & MarketingRegulation

FDA accepts for review Synageva's Biologics License Application for Kanuma

FDA accepts for review Synageva's Biologics License Application for Kanuma

23-02-2015

The US Food and Drug Administration has accepted for review the Biologics License Application for Kanuma…

BiotechnologyGeneticsKanumaRegulationSynageva BioPharmaUSA

Holoclar, the first stem cell-based medicinal product approved in Europe

Holoclar, the first stem cell-based medicinal product approved in Europe

22-02-2015

The European Commission has granted a conditional marketing authorization, under Regulation (EC) No 726/2004,…

BiotechnologyChiesi FarmaceuticiEuropeHoloclarHolostem Terapie AvanzateOphthalmicsRegulation

Actavis receives final FDA approval for generic version of Subutex

Actavis receives final FDA approval for generic version of Subutex

22-02-2015

Ireland-headquartered generics major Actavis has received final approval from the US Food and Drug Administration…

Abbreviated New Drug ApplicationGenericsIndiviorNeurologicalRC PharmaceuticalsReckitt BenckiserRegulationSubutexUSA

European approval for expanded use of Celgene’s Revlimid

20-02-2015

US biotech firm Celgene’s European subsidiary has received approval from the European Commission for…

BiotechnologyCelgene CorpEuropeOncologyRegulationRevlimid

IQWiG says Octapharma provided no suitable data on Nuwiq to show added benefit

IQWiG says Octapharma provided no suitable data on Nuwiq to show added benefit

20-02-2015

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined data on independent…

BiotechnologyGermanyHematologyNuwiqOctapharmaPricingRegulation

FDA accepts and grants priority review for Genentech's cobimetinib/Zelboraf

FDA accepts and grants priority review for Genentech's cobimetinib/Zelboraf

20-02-2015

Genentech, part of the Roche Group, says that the US Food and Drug Administration has accepted and granted…

cobimetinibGenentechOncologyPharmaceuticalRegulationRocheUSA

EU health stakeholders set up EMVO to help fight counterfeit medicines

EU health stakeholders set up EMVO to help fight counterfeit medicines

20-02-2015

Major European health care stakeholders have taken a major step to secure the legitimate pharmaceutical…

EuropeHealthcarePharmaceuticalRegulation

NICE makes preliminary recommendation on Allergan's Ozurdex for macular edema

NICE makes preliminary recommendation on Allergan's Ozurdex for macular edema

20-02-2015

The UK’s National Institutes of Health and Care Excellence has recommended Ozurdex (dexamethasone),…

AllerganDexamethasoneOphthalmicsOzurdexPharmaceuticalRegulationUK

NICE gives green light to Bayer’s Eylea for DME

20-02-2015

In a preliminary recommendation issued today, England’s health costs watchdog the National Institute…

BayerEyleaOphthalmicsPharmaceuticalPricingRegulationUK

NICE final draft guidance recommends Norgine's Targaxan

NICE final draft guidance recommends Norgine's Targaxan

19-02-2015

The UK’s National Institute for Health and Care Excellence has published its final draft guidance recommending…

Nephrology and HepatologyNeurologicalNorginePharmaceuticalRegulationTargaxanUK

Pharma violates own marketing regulations, Swedish study alleges

Pharma violates own marketing regulations, Swedish study alleges

19-02-2015

A new report from Lund University in Sweden claims to show how the pharmaceutical industry, time and…

Markets & MarketingPharmaceuticalRegulationSwedenUK

US FDA expands use of Celgene’s Revlimid

18-02-2015

US biotech firm Celgene revealed that the US Food and Drug Administration has expanded the existing indication…

BiotechnologyCelgene CorpOncologyRegulationRevlimidUSA

EMA Orphan Drug status for aTyr’s Resolaris in FSHD

18-02-2015

Privately-held US biotech firm aTyr Pharma says that the European Commission has granted Orphan Drug…

ATyr PharmaBiotechnologyEuropeRare diseasesRegulationResolaris

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