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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

Genentech files sBLA for Lucentis for diabetic retinopathy

09-08-2014

Genentech, the biotech subsidiary of Swiss pharma major Roche, has submitted a supplemental Biologics…

BiotechnologyGenentechLucentisOphthalmicsRegulationRocheUSA

Regeneron’s Eylea gains FDA approval for DME

Regeneron’s Eylea gains FDA approval for DME

30-07-2014

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

BayerBiotechnologyEyleaOphthalmicsRegeneronRegulationUSA

pSivida’s Iluvien given marketing authorization in Norway and reimbursement approval in Portugal

pSivida’s Iluvien given marketing authorization in Norway and reimbursement approval in Portugal

29-07-2014

Eye disease specialist pSivida has been granted marketing authorization in Norway for its treatment Iluvien,…

IluvienNorwayOphthalmicsPharmaceuticalPortugalpSividaRegulation

Alcon’s Simbrinza approved for glaucoma in the EU

Alcon’s Simbrinza approved for glaucoma in the EU

28-07-2014

Eyecare specialist Alcon, a division of Swiss drug major Novartis, says its Simbrinza eye drops suspension…

AlconEuropeEuropean CommissionGlaucomaOphthalmicsPharmaceuticalRegulationSimbrinza

EUCOPE slams French plans to cut spending through off-label drugs

EUCOPE slams French plans to cut spending through off-label drugs

12-07-2014

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) says it is very concerned about legislative…

AvastinEuropeFranceLegalOphthalmicsPharmaceuticalRegulationRoche

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

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

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