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Taiho Pharma Europe submits marketing application to EMA for TAS-102 in colorectal cancer

Taiho Pharma Europe submits marketing application to EMA for TAS-102 in colorectal cancer

02-03-2015

Taiho Pharma Europe, a subsidiary of Japanese pharma company Otsuka (TYO: 4768), has submitted a marketing…

EuropeOncologyPharmaceuticalRegulationTaiho PharmaceuticalsTAS-102

Global drugmakers slam restrictions on state tendering in Russia

02-03-2015

Leading global pharmaceutical producers operating in the Russian market have criticized a recent decision…

PharmaceuticalPricingRegulationRussia

South Korea pharma news briefs

02-03-2015

News items, as posted by the Korean Research-based Pharmaceutical Industry Association (KRPIA) last month,…

FinancialPharmaceuticalPricingRegulationSouth Korea

Novartis hit with 15-day suspension over omission of adverse events reporting

Novartis hit with 15-day suspension over omission of adverse events reporting

02-03-2015

Swiss drug major Novartis has been ordered to suspend operations in Japan for 15 days as of March 5,…

JapanLegalNovartisPharmaceuticalRegulation

Three new drugs recommended for approval by EMA/CHMP

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

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

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

NICE recommends AbbVie's Humira and Merck's Remicade and Simponi for ulcerative colitis

NICE recommends AbbVie's Humira and Merck's Remicade and Simponi for ulcerative colitis

25-02-2015

The UK’s health regulator, the National Institute for Health and Care Excellence (NICE) has recommended…

AbbVieGastro-intestinalsHumiraMerck & CoPharmaceuticalRegulationRemicadeSimponi InjectionUK

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

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

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

FDA issues new draft documents related to compounding of human drugs

FDA issues new draft documents related to compounding of human drugs

17-02-2015

The US Food and Drug Administration issued five draft documents related to drug compounding and repackaging…

FDAHealthPharmaceuticalPharmaceutical sciencesPharmacologyRegulationSterile compounded drug productsUSA

1 to 25 of 2175 results

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