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Sanofi's NDA for basal insulin Toujeo accepted by FDA

Sanofi's NDA for basal insulin Toujeo accepted by FDA

08-07-2014

The US Food and Drug Administration has accepted for review French pharma major Sanofi’s New Drug Application…

DiabetesPharmaceuticalRegulationSanofiToujeoUSA

Japan marketing approval for Canaglu; vaccine license for Daiichi Sankyo

Japan marketing approval for Canaglu; vaccine license for Daiichi Sankyo

04-07-2014

Japanese drug major Mitsubishi Tanabe Pharma has received approval to manufacture and market the SGLT2…

canagliflozinCanagluDaiichi SankyoDiabetesJapanMitsubishi TanabePharmaceuticalRegulationSanofi PasteurVaccines

FDA approves MannKind’s Afrezza to treat diabetes

FDA approves MannKind’s Afrezza to treat diabetes

30-06-2014

In a much awaited decision, the US Food and Drug Administration on Friday approved MannKind Corp’s…

AfrezzaDiabetesMannKindPharmaceuticalRegulationUSA

FDA review of CV risks for diabetics taking olmesartan not conclusive

FDA review of CV risks for diabetics taking olmesartan not conclusive

25-06-2014

The US Food and Drug Administration has completed its safety review and has found no clear evidence of…

BenicarCardio-vascularDaiichi SankyoDiabetesolmesartanPharmaceuticalRegulationUSA

UK’s NICE approves Janssen’s Invokana for type 2 diabetes

UK’s NICE approves Janssen’s Invokana for type 2 diabetes

25-06-2014

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

DiabetesInvokanaJanssenPharmaceuticalRegulationUK

Boehringer and Lilly re-file empagliflozin NDA with FDA

Boehringer and Lilly re-file empagliflozin NDA with FDA

19-06-2014

The US subsidiary of German family-owned drugmaker Boehringer Ingelheim and pharma major Eli Lilly have…

Boehringer IngelheimDiabetesEli LillyempagliflozinPharmaceuticalRegulationUSA

Added benefit of Invokana in type 2 diabetes is not proven, says IQWiG

Added benefit of Invokana in type 2 diabetes is not proven, says IQWiG

17-06-2014

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

DiabetesGermanyInvokanaJanssen-CilagJohnson & JohnsonPharmaceuticalPricingRegulation

Boehringer and Lilly’s diabetes drug Jardiance gains EU approval

23-05-2014

German family-owned pharma major Boehringer Ingelheim and US partner Eli Lilly have received Marketing…

Boehringer IngelheimDiabetesEli LillyempagliflozinEuropeJardiancePharmaceuticalRegulation

Negative IQWiG view on AstraZeneca’s combo diabetes drug Xigduo

16-05-2014

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

AstraZenecaDiabetesGermanyPharmaceuticalPricingRegulationXigduo

UK’s NICE backs Janssen’s Invokana for type 2 diabetes

16-05-2014

Janssen, a subsidiary of US health care giant Johnson & Johnson, said today that it welcomes the publication…

DiabetesInvokanaJanssenJohnson & JohnsonPharmaceuticalPricingRegulationUK

Janssen’s Vokanamet approved in EU for adults with type 2 diabetes

28-04-2014

The European Commission has approved US health care giant Johnson & Johnson subsidiary Janssen-Cilag’s…

BiotechnologyDiabetesEuropeJanssen-CilagJohnson & JohnsonRegulationVokanamet

FDA finally OKs GlaxoSmithKline’s Tanzeum to treat type 2 diabetes

FDA finally OKs GlaxoSmithKline’s Tanzeum to treat type 2 diabetes

16-04-2014

UK pharma giant GlaxoSmithKline yesterday received the much anticipated approval from the US Food and…

albiglutideDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationTanzeumUSA

NDA filing for empagliflozin and linagliptin combo accepted by FDA

NDA filing for empagliflozin and linagliptin combo accepted by FDA

14-04-2014

The US Food and Drug Administration has accepted the filing of the New Drug Application for the investigational…

Boehringer IngelheimDiabetesEli LillyempagliflozinJardiancelinagliptinNorth AmericaPharmaceuticalRegulationTradjentaUSA

MannKind’s diabetes drug Afrezza recommended by FDA advisory

02-04-2014

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday…

AfrezzaDiabetesMannKindNorth AmericaPharmaceuticalRegulationUSA

GSK announces delay in Mekinist/Tafinlar MAA; EU approval of Eperzan

GSK announces delay in Mekinist/Tafinlar MAA; EU approval of Eperzan

27-03-2014

UK pharma giant GlaxoSmithKline released a couple of news items yesterday, one slightly negative regarding…

DiabetesEperzanEuropeGlaxoSmithKlineMekinistOncologyPharmaceuticalRegulationTafinlar

Japanese approval for Forxiga and Lonsurf

24-03-2014

Anglo-Swedish drug major AstraZeneca says that Japanese Ministry of Health, Labor and Welfare approved…

Asia-PacificAstraZenecaDiabetesForxigaJapanLonsurfOncologyOno PharmaceuticalOtsukaPharmaceuticalRegulationTaiho Pharmaceutical

EMA/CHMP recommends empagliflozin for approval for type 2 diabetes

23-03-2014

German family-owned drug major Boehringer Ingelheim and partner Eli Lilly of the USA have announce a…

Boehringer IngelheimDiabetesEli LillyempagliflozinEuropeJardiancePharmaceuticalRegulation

Label updates for Tresiba and Victoza backed by EMA committee

21-03-2014

The European Medicines agency’s Committee for Medicinal Products for Human Use has issued positive…

DiabetesEuropeNovo NordiskPharmaceuticalRegulationTresibaVictoza

Pharma Summit: Merck’s European president Bruno Strigini highlights importance of innovation

Pharma Summit: Merck’s European president Bruno Strigini highlights importance of innovation

17-03-2014

The president of pharma giant Merck & Co’s (NYSE: MRK) operations in Europe and Canada Bruno Strigini…

Anti-viralsCanadaDiabetesEuropeInterviewsMerck & CoMK-3475OncologyPharmaceuticalRegulationUKVaccines

AstraZeneca’s diabetes drug Xigduo launched in UK

AstraZeneca’s diabetes drug Xigduo launched in UK

11-03-2014

Anglo-Swedish drug major AstraZeneca’s type 2 diabetes drug Xigduo is now available in the UK.

AstraZenecaDiabetesPharmaceuticalRegulationUKXigduo

Takeda files for diabetes drug trelagliptin succinate approval in Japan

Takeda files for diabetes drug trelagliptin succinate approval in Japan

09-03-2014

Takeda Pharmaceutical, Japan’s largest drugmaker, has submitted a New Drug Application to the Japanese…

Asia-PacificBlopressCardio-vascularDiabetesJapanPharmaceuticalRegulationResearchTakeda Pharmaceuticalstrelagliptin

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

05-03-2014

There was disappointment today for US drug major Eli Lilly and family-owned German pharma firm Boehringer…

Boehringer IngelheimDiabetesEli LillyempagliflozinNorth AmericaPharmaceuticalProductionRegulationUSA

FDA approves Bydureon Pen for type 2 diabetes

FDA approves Bydureon Pen for type 2 diabetes

03-03-2014

Anglo-Swedish drug major AstraZeneca says the US Food and Drug Administration has approved the Bydureon…

AlkermesAmylinAstraZenecaBristol-Myers SquibbBydureonDiabetesPharmaceuticalRegulationUSA

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