Regulation - Ophthalmics

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European Commission approves Santen Pharma’s Ikervis for eye disease

25-03-2015

Japanese drugmaker Santen Pharmaceutical has received approval of the Marketing Authorization Application…

EuropeIkervisOphthalmicsPharmaceuticalRegulationSanten Pharmaceuticals

Pfenex gets early HSR clearance for collaboration with Hospira

23-03-2015

The US Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino…

BiosimilarsBiotechnologyGenentechHospiraLicensingLucentisOphthalmicsPF582PfenexRegulationRocheUSA

Shire files for US approval of Lifitegrast for dry eye disease

02-03-2015

Ireland-based drugmaker Shire has submitted a New Drug Application with the US Food and Drug Administration…

BiotechnologyEBI-005Eleven BiotherapeuticsLifitegrastOphthalmicsRegulationShireUSA

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

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

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

Further approvals for ThromboGenics’ Jetrea

12-02-2015

Belgian biotech company ThromboGenics, which is focused on developing and commercializing innovative…

AlconArgentinaBiotechnologyIsraelJetreaNovartisOphthalmicsRegulationThromboGenics

FDA approves added indication for Genentech’s Lucentis

FDA approves added indication for Genentech’s Lucentis

08-02-2015

The US Food and Drug Administration on Friday approved Swiss pharma giant Roche subsidiary Genentech’s…

BiotechnologyGenentechLucentisNovartisOphthalmicsRegulationRocheUSA

Nicox holds successful pre-NDA meeting with FDA for AC-170

Nicox holds successful pre-NDA meeting with FDA for AC-170

26-01-2015

French ophthalmics company Nicox has held a positive pre-New Drug Application meeting with the US Food…

AC-170NicOxOphthalmicsPharmaceuticalRegulationUSA

Akorn files ANDA for generic Durezol

16-01-2015

US generic drugmaker Akorn has confirmed that it has filed an Abbreviated New Drug Application (ANDA)…

AkornAlconDurezolGenericsNovartisOphthalmicsPatentsRegulationUSA

Novartis' Alcon granted additional pediatric indication by the European Commission for Travatan

Novartis' Alcon granted additional pediatric indication by the European Commission for Travatan

23-12-2014

Eyecare specialist Alcon, the second-largest division of Swiss drug major Novartis, has been granted…

AlconNovartisOphthalmicsPharmaceuticalRegulationTravatanUSA

Added benefit of Eylea over Lucentis in DME not proven, says IQWiG

Added benefit of Eylea over Lucentis in DME not proven, says IQWiG

16-12-2014

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

BayerEyleaGermanyLucentisNovartisOphthalmicsPharmaceuticalPricingRegulationRoche

Bayer/Regeneron’s Eylea approved in Japan for DME

18-11-2014

German pharma major Bayer’s Japanese subsidiary, Bayer Yakuhin, has received approval from the Ministry…

BayerBiotechnologyEyleaJapanOphthalmicsRegeneronRegulation

French regulator requests information from Roche on off-label use of Avastin for wet-AMD

French regulator requests information from Roche on off-label use of Avastin for wet-AMD

07-11-2014

The French pharma regulator, l’Agence nationale de sécurité du médicament et des produits de santé…

AvastinFranceOphthalmicsPharmaceuticalRegulationRoche

Clanotech granted orphan drug designation by EMA for post-glaucoma surgery drug CLT-28643

Clanotech granted orphan drug designation by EMA for post-glaucoma surgery drug CLT-28643

20-10-2014

Swedish ophthalmic specialist Clanotech, which is 80% owned by Karolinska Development, has received orphan…

ClanotechCLT-28643Karolinska DevelopmentOphthalmicsPharmaceuticalRegulationSweden

Regeneron gains further FDA indications for Eylea

Regeneron gains further FDA indications for Eylea

07-10-2014

The US Food and Drug Administration has approved biotech firm Regeneron Pharmaceuticals’ Eylea (aflibercept)…

BayerBiotechnologyEyleaOphthalmicsRegeneron PharmaceuticalsRegulationUSA

US FDA approves Iluvien for diabetic macular edema

US FDA approves Iluvien for diabetic macular edema

28-09-2014

US ophthalmic drug specialist Alimera Sciences says that the US Food and Drug Administration has approved…

Alimera SciencesIluvienMedidurOphthalmicsPharmaceuticalpSividaRegulationTethadurUSA

Bayer’s Eylea approved in Japan for myopic CNV

Bayer’s Eylea approved in Japan for myopic CNV

22-09-2014

Bayer Yakuhin, the Japanese health care subsidiary if Germany’s Bayer has received approval from Japan’s…

BayerEyleaJapanOphthalmicsPharmaceuticalRegeneron PharmaceuticalsRegulation

FDA grants Breakthrough status for Eylea in diabetic retinopathy in patients with DME

FDA grants Breakthrough status for Eylea in diabetic retinopathy in patients with DME

16-09-2014

US biotech firm Regeneron Pharmaceuticals says that the US Food and Drug Administration has granted Eylea…

BayerBiotechnologyEyleaOphthalmicsRegeneron PharmaceuticalsRegulationUSA

Allergan’s Ozurdex approved for DME in Europe

Allergan’s Ozurdex approved for DME in Europe

02-09-2014

Allergan revealed today that the European Commission has extended the marketing authorization for Ozurdex…

AllerganEuropeOphthalmicsOzurdexPharmaceuticalRegulation

Thrombogenics gets Spanish reimbursement approval for Jetrea

Thrombogenics gets Spanish reimbursement approval for Jetrea

01-09-2014

Ophthalmic specialist ThromboGenics has received reimbursement in Spain from the Spanish Ministry of…

AlconJetreaNon-steroidal anti-inflammatory drugsOphthalmicsPharmaceuticalRegulationSpainThromboGenics

Eylea approved for diabetic macular edema in Europe

Eylea approved for diabetic macular edema in Europe

11-08-2014

The European Commission has approved German pharma major Bayer’s Eylea (aflibercept) injection for…

BayerEuropeEyleaOphthalmicsOphthalmologyPharmaceuticalRegeneronRegulation

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