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Bayer’s Nexavar cleared in Japan for differentiated thyroid cancer

Bayer’s Nexavar cleared in Japan for differentiated thyroid cancer

20-06-2014

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved German pharma major Bayer’s oral…

BayerJapanNexavarOncologyPharmaceuticalRegulation

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

FDA approves new indication for Bayer's Kogenate

12-05-2014

The US Food and Drug Administration has approved a new indication for German drug major Bayer's Kogenate…

BayerHematologyKogenate FSPharmaceuticalRegulationUSA

GPs lack awareness of NICE guidelines on HMB, survey shows

GPs lack awareness of NICE guidelines on HMB, survey shows

09-05-2014

Less than 5% of UK general practitioners (GPs) prescribe in line with guidelines from the National Institute…

BayerHealth Medical PharmaHealth Medical PharmaMilitary scienceNavigationPharmaceuticalRegulationSocial IssuesUKWomen's Health

EMA recommends extending use of Bayer’s Nexavar

27-04-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended…

BayerEuropeNexavarOncologyPharmaceuticalRegulation

Genzyme to resubmit Lemtrada NDA for FDA review

Genzyme to resubmit Lemtrada NDA for FDA review

07-04-2014

Genzyme, the biotech subsidiary of French drug major Sanofi, said this morning that, following “constructive…

BayerBiotechnologyLemtradaNeurologicalNorth AmericaRegulationSanofiUSA

Germany’s IQWiG views Xofigo, Kadcyla and Eviplera

03-04-2014

In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products, the…

Anti-viralsBayerEvipleraGermanyGilead SciencesKadcylaNorthern EuropeOncologyPharmaceuticalPricingRegulationRocheXofigo

Bayer’s Adempas gains EU clearance for two forms of PAH

Bayer’s Adempas gains EU clearance for two forms of PAH

31-03-2014

Following a previous positive opinion from the European Medicines Agency’s advisory committee, the…

AdempasBayerEuropePharmaceuticalRegulationRespiratory and Pulmonary

UK’s NICE unable to give the go ahead to new prostate cancer drug Xofigo

24-03-2014

The UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued new draft…

BayerNorthern EuropeOncologyPharmaceuticalPricingRegulationUKXofigo

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

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

14-02-2014

There was further negative news for Germany’s Bayer and partner US health care giant Johnson & Johnson,…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

Bayer gets “green light” for new transparent low dose contraceptive patch in the EU

Bayer gets “green light” for new transparent low dose contraceptive patch in the EU

14-02-2014

Germany’s Bayer says it has successfully concluded the decentralized European registration procedure…

BayerethinylestradiolEuropegestodenePharmaceuticalRegulationReproductive

Japanese approval for Bayer’s riociguat for CTEPH

Japanese approval for Bayer’s riociguat for CTEPH

20-01-2014

German pharma major Bayer has received approval from the Ministry of Health, Labor and Welfare for riociguat,…

AdempasAsia-PacificBayerPharmaceuticalRegulationRespiratory and Pulmonaryriociguat

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

17-01-2014

The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted against…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

Hint of minor added benefit for Bayer’s Stivarga seen by IQWiG

Hint of minor added benefit for Bayer’s Stivarga seen by IQWiG

13-01-2014

There was a hint of positive news for German drug major Bayer, when the German Institute for Quality…

BayerGermanyNorthern EuropeOncologyPharmaceuticalPricingRegulationStivarga

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

Cubist’s tedizolid NDA accepted for priority review in USA

Cubist’s tedizolid NDA accepted for priority review in USA

31-12-2013

The US Food and Drug Administration has accepted Cubist Pharmaceuticals’ New Drug Application for its…

Antibiotics and Infectious diseasesBayerCubist PharmaceuticalsNorth AmericaPharmaceuticalRegulationtedizolidTrius TherapeuticsUSA

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

US FDA calls for more trials on Genzyme’s Lemtrada

US FDA calls for more trials on Genzyme’s Lemtrada

30-12-2013

There was a significant disappointment this morning for French drug major Sanofi, when it revealed that…

BayerGenzymeLemtradaNeurologicalNorth AmericaPharmaceuticalRegulationSanofiUSA

Benefits of Kogenate/Helixate NexGen outweigh risks, says EMA unit

Benefits of Kogenate/Helixate NexGen outweigh risks, says EMA unit

08-12-2013

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the…

BayerCardio-vascularCSL BehringCSL LimitedEuropeHelixateHematologyKogenatePharmaceuticalRegulation

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

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