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France adopts draft law on off-label use of drugs

France adopts draft law on off-label use of drugs

09-07-2014

The French National Assembly yesterday voted on the draft law proposal, which would potentially allow…

AvastinDraft law proposalEuropeFranceLegalOphthalmicsPharmaceuticalRegulationRoche

Thrombogenics’ Jetrea gains first Latin American approval in Uruguay

Thrombogenics’ Jetrea gains first Latin American approval in Uruguay

02-07-2014

Belgium-based biopharma firm ThromboGenics has said that Jetrea (ocriplasmin) has been approved in Uruguay…

JetreaOphthalmicsPharmaceuticalRegulationThromboGenicsUruguay

pSivida’s marketing authorizations for Iluvien in 10 countries reaches next stage

pSivida’s marketing authorizations for Iluvien in 10 countries reaches next stage

01-07-2014

Drug delivery specialists pSivida says that the regulatory process for marketing authorizations of Iluvien…

EuropeIluvienOphthalmicsPharmaceuticalpSividaRegulation

US FDA delays Allergan’s Semprana decision, approves Ozurdex

US FDA delays Allergan’s Semprana decision, approves Ozurdex

01-07-2014

US drugmaker Allergan, the subject of a hostile $53 billion takeover pursuit by Canada’s Valeant Pharmaceuticals…

AllerganBimatoprost Ophthalmic Solution 0.03% for GlaLevadexNeurologicalOphthalmicsOzurdexPharmaceuticalRegulationResearchSempranaUSA

Added indications recommended by EMA/CHMP

Added indications recommended by EMA/CHMP

27-06-2014

Along with backing for approval for six news drugs issued at the late June meeting of the European Medicines…

AvastinBayerBristol-Myers SquibbCardio-vascularEliquisEuropeEyleaKalydecoOncologyOphthalmicsPfizerPharmaceuticalRare diseasesRegulationRocheVertex Pharmaceuticals

Alimera’s Iluvien is granted marketing authorization for DME in Italy

Alimera’s Iluvien is granted marketing authorization for DME in Italy

23-06-2014

The Italian Medicines Agency (Agenzia Italiana del Farmaco) has granted marketing authorization for Iluvien…

Alimera SciencesIluvienItalyOphthalmicsPharmaceuticalRegulation

Novartis outlines aims to be more profitable and increasingly focused

Novartis outlines aims to be more profitable and increasingly focused

19-06-2014

Swiss drug major Novartis has set out its new focused portfolio at the first Meet Novartis Management…

EuropeManagementNovartisOncologyOphthalmicsPharmaceutical

Drug policy expert calls for “nip in the bud” for AMD therapy drug substitute

Drug policy expert calls for “nip in the bud” for AMD therapy drug substitute

16-06-2014

Steven Bradshaw, a UK-based drug policy expert and former ophthalmologist, is disappointed at the news…

AvastinEuropeItalyLucentisOphthalmicsPharmaceuticalRegulationRoche

Bayer files for EMA approval of Eylea for macular edema secondary to BRVO

Bayer files for EMA approval of Eylea for macular edema secondary to BRVO

11-06-2014

German pharma major Bayer has submitted an application to the European Medicines Agency seeking marketing…

BayerEuropeEyleaOphthalmicsPharmaceuticalRegeneronRegulation

Italian legislation undermines EU regulatory framework by endorsing off-label drug use for economic reasons

Italian legislation undermines EU regulatory framework by endorsing off-label drug use for economic reasons

11-06-2014

The European Federation of Pharmaceutical Industries and Associations says it is concerned about a decision…

AvastinEuropeFinancialItalyNovartisOphthalmicsPharmaceuticalRegulationRoche

US retinal specialists very receptive to pipeline agents for dry-AMD

US retinal specialists very receptive to pipeline agents for dry-AMD

05-06-2014

Surveyed US retinal specialists are highly willing to prescribe key emerging therapies for the treatment…

emixustatGlaxoSmithKlineGSK-933776Markets & MarketingOphthalmicsOtsukaPharmaceuticalResearchUSA

EMA validates Santhera’s Marketing Authorization Application for Raxone

EMA validates Santhera’s Marketing Authorization Application for Raxone

05-06-2014

The European Medicines Agency has validated a Marketing Authorization Application (MAA) for Leber’s…

EuropeOphthalmicsPharmaceuticalRaxoneRegulationSanthera Pharmaceuticals

Avastin could save the USA $29 billion if used instead of Lucentis

Avastin could save the USA $29 billion if used instead of Lucentis

04-06-2014

Using Avastin (bevacizumab) from Swiss drug major Roche instead of Lucentis (ranibizumab) from fellow…

AvastinBevacizumabFinancialLucentisNovartisOphthalmicsPharmaceuticalRocheUSA

EMA/CHMP backs Alcon’s Simbrinza for glaucoma

25-05-2014

Swiss drug major Novartis’ eye care division Alcon says that the European Medicines Agency’s Committee…

AlconEuropeNovartisOphthalmicsPharmaceuticalRegulationSimbrinza

AbbVie gains FDA orphan designation for Humira in uveitis

21-05-2014

The US Food and Drug Administration granted US drugmaker AbbVie’s blockbuster rheumatoid arthritis…

AbbVieHumiraOphthalmicsPharmaceuticalRegulationUSA

Shire plans NDA filing with FDA for Lifitegrast in 1st-qtr 2015

18-05-2014

Following a May 15, 2014, meeting with the US Food and Drug Administration, Ireland-headquartered drugmaker…

LifitegrastManagementOphthalmicsPharmaceuticalRegulationShire

Merck & Co sells ophthalmic brands and Colorado biologicals unit

Merck & Co sells ophthalmic brands and Colorado biologicals unit

13-05-2014

US pharma giant Merck & Co has entered into two more divestment transactions, following the recent sell-off…

KBI BiopharmaMerck & CoMergers & AcquisitionsOphthalmicsPharmaceuticalProductionSanten Pharmaceuticals

Novartis presents real world data for Lucentis

Novartis presents real world data for Lucentis

09-05-2014

Swiss drug major Novartis has reported data on the eye drug Lucentis (ranibizumab) at the 2014 Association…

AMDEuropeHealthLucentisMajorMedicineNovartisOphthalmicsOphthalmologyPharmaceuticalResearch

Santhera re-files for EU approval of Raxone in the treatment of LHON

07-05-2014

Swiss drugmaker Santhera Pharmaceuticals has re-filed its Marketing Authorization Application for Raxone…

EuropeOphthalmicsPharmaceuticalRare diseasesRaxoneSanthera Pharmaceuticals

Shire 1st-qrt 2014 sales and earnings rocket; lifitegrast disappoints

01-05-2014

Ireland-headquartered drugmaker Shire posted a strong set of financials this afternoon, showing that…

FinancialLifitegrastOphthalmicsPharmaceuticalRare diseasesResearchShire

French competition authority investigating Roche and Novartis over Lucentis marketing

10-04-2014

Following similar recent action by the equivalent Italian body, the French competition authority is launching…

AvastinBevacizumabFranceItalyLegalLucentisMarkets & MarketingMedicineNorthern EuropeNovartisOphthalmicsPharmaceuticalPharmacologyRocheUSD

Alimera resubmits NDA for Iluvien

Alimera resubmits NDA for Iluvien

27-03-2014

US ophthalmic pharma specialist Alimera Sciences has resubmitted its New Drug Application for Iluvien…

AlimeraAlimera SciencesIluvienOphthalmicsPharmaceuticalRegulationUSA

India’s Lupin acquires Laboratorios Grin to enter Latin American market

27-03-2014

Indian pharma major Lupin has acquired a 100% equity stake in Mexican company Laboratorios Grin, subject…

IndiaLaboratorios GrinLupinMergers & AcquisitionsMexicoOphthalmicsPharmaceutical

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