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Positive Ph III results from Biogen Idec and SOBI’s Alprolix in pediatric study

28-02-2015

US biotech major Biogen Idec and Nordic drugmaker Swedish Orphan Biovitrum have announced positive top-line…

AlprolixBiogen IdecBiotechnologyEuropeHematologyRegulationResearchSobiSwedish Orphan Biovitrum

Three new drugs recommended for approval by EMA/CHMP

27-02-2015

Three new medicines have been recommended for approval at the February 2015 meeting of the European Medicines…

AmgenEuropeJinarcNephrology and HepatologyNovartisOncologyOtsuka PharmaceuticalPharmaceuticalRegulationRistempaVectibixZykadia

India plans to impose price controls on medical device makers and distributors

27-02-2015

In a major crackdown, India's drug regulator the National Pharmaceutical Pricing Authority has come down…

IndiaPharmaceuticalPricingRegulation

EC approves Zambon and Newron’s Xadago for late-stage PD patients

EC approves Zambon and Newron’s Xadago for late-stage PD patients

27-02-2015

Zambon and its partner, fellow Italy-based Newron Pharmaceuticals, have received approval from the European…

EuropeNeurologicalNewron PharmaceuticalsPharmaceuticalRegulationXadagoZambon

Amgen and Onyx’s MAA for Kyprolis is accepted by EMA

Amgen and Onyx’s MAA for Kyprolis is accepted by EMA

27-02-2015

The European Medicines Agency has accepted the Marketing Authorization Application for Kyprolis (carfilzomib)…

AmgenEuropeKyprolisOncologyOnyx PharmaceuticalsPharmaceuticalRegulation

Chiesi found to have breached ABPI Code

Chiesi found to have breached ABPI Code

27-02-2015

Privately-held Italian drugmaker Chiesi Farmaceutici has been publicly reprimanded for providing inaccurate…

Chiesi FarmaceuticiFostairLegalPharmaceuticalRegulationUK

‘New option’ for diabetes as Sanofi receives FDA approval of Toujeo

‘New option’ for diabetes as Sanofi receives FDA approval of Toujeo

26-02-2015

The US Food and Drug Administration has approved French pharma major Sanofi’s Toujeo (insulin glargine…

DiabetesPharmaceuticalRegulationSanofiToujeoUSA

US FDA approves new antibacterial drug Avycaz

US FDA approves new antibacterial drug Avycaz

26-02-2015

The US Food and Drug Administration has approved antibacterial drug Avycaz (ceftazidime-avibactam) to…

ActavisAntibiotics and Infectious diseasesceftazidime-avibactamForest PharmaceuticalsPharmaceuticalRegulationUSA

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

1 to 25 of 2739 results

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