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FDA probing Regeneron and Sanofi’s investigational drug alirocumab

FDA probing Regeneron and Sanofi’s investigational drug alirocumab

10-03-2014

French drug major Sanofi has revealed in a regulatory filing that the US Food and Drug Administration…

alirocumabCardio-vascularNorth AmericaPharmaceuticalRegeneronRegulationResearchSanofiUSA

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 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

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

Drug approvals for Bayer in USA and Japan

Drug approvals for Bayer in USA and Japan

23-11-2013

There were two pieces of good news for German Pharma and chemicals major Bayer on Friday (November 22),…

AmgenAsia-PacificBayerBiotechnologyEyleaNexavarNorth AmericaOncologyOnyx PharmaceuticalsOphthalmicsPharmaceuticalRegeneronRegulation

Eylea filed for EU and US approval in diabetic macular edema

Eylea filed for EU and US approval in diabetic macular edema

07-11-2013

US biotech firm Regeneron Pharmaceuticals says its partner German drug major Bayer has submitted an application…

BayerDiabetesEuropeEyleaNorth AmericaOphthalmicsPharmaceuticalRegeneronRegulation

EU approval for Ilaris in active systemic juvenile idiopathic arthritis

03-09-2013

Following a positive recommendation from the European Medicines Agency's Committee for Medicinal Products…

Anti-Arthritics/RheumaticsEuropeIlarisNovartisPharmaceuticalRegeneronRegulation

Bayer gains new Eylea indication in Europe

29-08-2013

Following a positive recommendation last month from the European Medicines Agency's Medicinal Products…

BayerEuropeEyleaOphthalmicsPharmaceuticalRegeneronRegulation

Germany's IQWiG finds no proof of added benefit for Bayer's Eylea

22-03-2013

There was disappointment for German drug major Bayer (BAYN: DE), when the German Institute for Quality…

BayerEuropeEyleaOphthalmicsPharmaceuticalPricingRegeneronRegulation

Novartis gets EU approval for expanded use of Ilaris, acute gouty arthritis

05-03-2013

The European Commission (EC) has approved Swiss drug major Novartis' (NOVN: VX) llaris (canakinumab,…

Anti-Arthritics/RheumaticsEuropeIlarisNovartisPharmaceuticalRegeneronRegulation

Briefs: Sanofi to up stake in Regeneron; Bayer files for riociguat approval

12-02-2013

US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) saw its shares rise 4.8% to $173.84 in early trading…

BayerBiotechnologyEuropeFinancialMergers & AcquisitionsNorth AmericaPharmaceuticalRegeneronRegulationRespiratory and PulmonaryriociguatSanofi

Sanofi's Zaltrap gets EU approval for metastatic colorectal cancer

06-02-2013

In a second European approval within a matter of days, French drug major Sanofi (Euronext: SAN) said…

EuropeOncologyPharmaceuticalRegeneronRegulationSanofiZaltrap

Bayer files for Japanese approval of Eylea for macular edema following CRVO

07-01-2013

German drug major Bayer(BAYN: DE) says its subsidiary Bayer Yakuhin has applied to the Japanese Ministry…

afliberceptAsia-PacificBayerBiotechnologyEyleaOphthalmicsPharmaceuticalRegeneronRegulationSanten Pharmaceuticals

EU Commission approves Bayer's Eylea for wet AMD and Abbott's Humira for pediatric Crohn's

28-11-2012

There was good news yesterday for Germany's Bayer (BAYN: DE) and US health care major Abbott Laboratories…

Abbott LaboratoriesBayerEuropeEyleaGastro-intestinalsHumiraOphthalmicsPharmaceuticalRegeneronRegulation

EMA backs Almirall's Constella; Bayer's Eylea recommended by CHMP

24-09-2012

The European Medicines Agency last Friday issued a batch of recommendations relating to marketing authorization…

AlmirallBayerConstellaEuropeEyleaGastro-intestinalsIronwood PharmaceuticalsNorth AmericaOphthalmicsPharmaceuticalRegeneronRegulation

Zaltrap gains US approval for metastatic colorectal cancer

06-08-2012

The US Food and Drug Administration on Friday approved French drug major Sanofi (Euronext: SAN) and US…

North AmericaOncologyPharmaceuticalRegeneronRegulationSanofiZaltrap

US FDA rejects Regeneron's Arcalyst sBLA for gout flare prevention

01-08-2012

US drugmaker Regeneron Pharmaceuticals (Nasdaq: REGN) says that the US Food and Drug Administration issued…

Anti-Arthritics/RheumaticsArcalystBiotechnologyNorth AmericaPharmaceuticalRegeneronRegulation

USA: FDA panel votes against Regeneron gout drug; Court upholds Abilify patent

09-05-2012

The US Food and Drug Administration's Arthritis Advisory Committee yesterday voted unanimously (11 to…

AbilifyAnti-Arthritics/RheumaticsArcalystBristol-Myers SquibbLegalNeurologicalNorth AmericaOtsukaPatentsPharmaceuticalRegeneronRegulation

Sanofi and Regeneron mCRC drug Zaltrap misses goals but gets FDA priority

10-04-2012

The US Food and Drug Administration has granted priority review of the Biologics License Application…

BiotechnologyNorth AmericaPharmaceuticalRegeneronRegulationResearchSanofiZaltrap

Australia latest to approve Bayer's Eylea

08-03-2012

The Australian Therapeutic Goods Administration (TGA) has approved Eylea (aflibercept) Injection for…

Asia-PacificBayerEyleaOphthalmicsPharmaceuticalRegeneronRegulation

Bayer to file for EU approval of aflibercept for central retinal vein occlusion

21-02-2012

German drug major Bayer (BAY: DE) says that it will file for European approval of its macular edema treatment…

afliberceptBayerEuropeEyleaOphthalmicsPharmaceuticalRegeneronRegulationResearch

Roche unit in partial patent deal with Regeneron over Eylea; new indication for Avastin

04-01-2012

Regeneron Pharmaceuticals (Nasdaq: REGN) says it has entered into a non-exclusive license and partial…

AvastinBiotechnologyEuropeEyleaGenentechLegalNorth AmericaOncologyOphthalmicsPatentsPharmaceuticalRegeneronRegulationRoche

FDA approves Regeneron’s Eylea for wet age-related macular degeneration

21-11-2011

Following unanimous advisory panel support for the drug, the US Food and Drug Administration has approved…

BayerBiotechnologyEyleaNorth AmericaOphthalmicsPharmaceuticalRegeneronRegulation

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