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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

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

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

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

First Asian approval for ophthalmic drug Jetrea, in Malaysia

18-04-2014

Belgian biotech firm ThromboGenics NV revealed today that Jetrea (ocriplasmin) has been approved in Malaysia…

AlconAsia-PacificBiotechnologyJetreaMalaysiaNovartisOphthalmicsRegulationThromboGenics

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

Bayer submits marketing authorization for Eylea in Japan

Bayer submits marketing authorization for Eylea in Japan

03-03-2014

US biotech firm Regeneron Pharmaceuticals and partner Bayer’s Japanese subsidiary Bayer Yakuhin have…

BayerEyleaJapanOphthalmicsPharmaceuticalRegeneronRegulation

UK’s NICE gives green light to Bayer’s Eylea in final guidance

26-02-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has published final guidance…

BayerEyleaNorthern EuropeOphthalmicsPharmaceuticalPricingRegulationUK

Novartis gets fourth indication, DME, for Lucentis in Japan

24-02-2014

Swiss drug major Novartis says it has received approval from Japanese regulatory bodies for a fourth…

Asia-PacificJapanLucentisNovartisOphthalmicsPharmaceuticalRegulation

Actavis confirms challenge to Allergan’s Restasis

22-01-2014

Generics drug major Actavis has confirmed that its Watson Laboratories unit has submitted an Abbreviated…

ActavisAllerganGenericsNorth AmericaOphthalmicsPatentsRegulationRestasisUSAWatson Pharmaceuticals

Added benefit of Bayer’s Eylea again not proven, says IQWiG

Added benefit of Bayer’s Eylea again not proven, says IQWiG

08-01-2014

For the third time in one year, the German Institute for Quality and Efficiency in Health Care (IQWiG)…

BayerEyleaGermanyNorthern EuropeOphthalmicsPharmaceuticalPricingRegulation

UK’s NICE backs second indication for Bayer’s Eylea

UK’s NICE backs second indication for Bayer’s Eylea

31-12-2013

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has today announced that…

BayerEuropeEyleaOphthalmicsPharmaceuticalPricingRegeneronRegulation

Alimera says FDA advisory committee on Iluvien no longer necessary

Alimera says FDA advisory committee on Iluvien no longer necessary

19-12-2013

US ophthalmic pharma specialist Alimera Sciences has entered into labeling discussions with the US Food…

Alimera SciencesIluvienNorth AmericaOphthalmicsPharmaceuticalpSividaRegulation

Bayer files VEGF Trap-Eye for myopic choroidal neovascularization in Japan

Bayer files VEGF Trap-Eye for myopic choroidal neovascularization in Japan

29-11-2013

German drug major Bayer (BAYN: DE) has submitted VEGF Trap-Eye, already marketed under the brand name…

Asia-PacificBayerEyleaOphthalmicsPharmaceuticalRegeneronRegulationUSA

NICE final guidance gives green light to Lucentis for CNV

NICE final guidance gives green light to Lucentis for CNV

27-11-2013

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

EuropeLucentisNovartisOphthalmicsPharmaceuticalPricingRegulation

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