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NICE issues new quality standard to prevent hepatitis B transmission

NICE issues new quality standard to prevent hepatitis B transmission

28-07-2014

On World Hepatitis Day today, the UK’s clinical standards body, the National Institute for Health and…

BaracludeBristol-Myers SquibbGilead SciencesHealthHepatitis BHepatologyMedicineNephrology and HepatologyPharmaceuticalPurinesRegulationUKViread

Veloxis and Chiesi receive approval from European Commission on anti-organ rejection drug

Veloxis and Chiesi receive approval from European Commission on anti-organ rejection drug

28-07-2014

Denmark-based Veloxis Pharmaceuticals and Italian company Chiesi Farmaceutici have said that the European…

Chiesi FarmaceuticiDenmarkEnvarsusEuropean CommissionItalyNephrology and HepatologyOrgan transplantsPharmaceuticalRegulationVeloxis Pharmaceuticals

Highlights of EMA Pharmacovigilance committee July meeting

Highlights of EMA Pharmacovigilance committee July meeting

14-07-2014

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) concluded two safety…

bromocriptineEuropeNephrology and HepatologyNeurologicalPharmaceuticalRegulationRiensoTakeda Pharmaceuticalvalproate Sodium InjectionWomen's Health

Alnylam and TAP collaborate on ALN-AAT, for AAT deficiency-associated liver disease

Alnylam and TAP collaborate on ALN-AAT, for AAT deficiency-associated liver disease

19-06-2014

RNAi therapeutics company Alnylam Pharmaceuticals and The Alpha-1 Project (TAP), the venture philanthropy…

ALN-AATAlnylam PharmaceuticalsBiotechnologyNephrology and HepatologyRegulationResearchThe Alpha-1 ProjectUSA

Otsuka’s Samsca, first ADPKD therapy, approved in Japan

25-03-2014

Japanese drugmaker Otsuka Pharmaceutical says it has become the first company in the world to obtain…

Asia-PacificJapanNephrology and HepatologyOtsukaPharmaceuticalRegulationSamsca

Keryx Biopharma files for EU approval of Zerenex

Keryx Biopharma files for EU approval of Zerenex

10-03-2014

US drugmaker Keryx Biopharmaceuticals has submitted a Marketing Authorization Application to the European…

EuropeKeryx BiopharmaceuticalsNephrology and HepatologyPharmaceuticalRegulationZerenex

FDA cites insufficient information in response to AMAG’s Feraheme application

FDA cites insufficient information in response to AMAG’s Feraheme application

23-01-2014

US drug company AMAG Pharmaceuticals (Nasdaq: AMAG) has received a complete response letter from the…

AMAG PharmaceuticalsFerahemeHematologyNephrology and HepatologyPharmaceuticalRegulationUSA

Velphoro receives US FDA approval for hyperphosphatemia in CKD

Velphoro receives US FDA approval for hyperphosphatemia in CKD

28-11-2013

Switzerland-based Vifor Pharma has received US Food and Drug Administration approval for Velphoro for…

Nephrology and HepatologyPharmaceuticalRegulationUSAVelphoroVifor Pharma

US orphan status for Pharmalink’s Busulipo

US orphan status for Pharmalink’s Busulipo

29-10-2013

Swedish specialty pharma group Pharmalink says its product Busulipo, (busulfan), a best-in-class conditioning…

BusulipoNefeconNephrology and HepatologyNorth AmericaOncologyPharmaceuticalPharmaLinkRegulationResearch

Otsuka's Samsca gains additional indication in Japan

17-09-2013

Japanese drugmaker Otsuka (TYO: 4768) says that its vasopressin V2 receptor antagonist Samsca (tolvaptan)…

Asia-PacificNephrology and HepatologyOtsukaPharmaceuticalRegulationSamscatolvaptan

Setback for Otsuka's tolvaptan

30-08-2013

The US subsidiary of Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) has received a Complete Response…

Nephrology and HepatologyOtsukaPharmaceuticalRegulationRest of the Worldtolvaptan

Keryx Biopharma files for US approval of Zerenex

09-08-2013

Keryx Biopharmaceuticals (Nasdaq: KERX) says it has submitted a New Drug Application to the US Food and…

BiotechnologyKeryx BiopharmaceuticalsNephrology and HepatologyNorth AmericaRegulationZerenex

Negative advisory view for Otsuka's tolvaptan in ADPKD

06-08-2013

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) says that the US Food and Drug Administration's…

Nephrology and HepatologyNorth AmericaOtsukaPharmaceuticalRegulationtolvaptin

UK's NICE recommends new therapy for liver cancer patients

30-07-2013

UK specialist health care company BTG (LSE: BTG) says that the UK's National Institute for Health and…

BiotechnologyBTGEuropeNephrology and HepatologyNordionOncologyRegulation

Vifor gains US FDA approval for Injectafer

26-07-2013

Switzerland-based Vifor Pharma, part of the Galenica group (SIX: GALN), has received approval from the…

FerinjectInjectaferLuitpold PharmaNephrology and HepatologyNorth AmericaPharmaceuticalRegulationVifor Pharma

Added benefit of Mitsubishi Tanabe's colestilan not proven, says German IQWiG

10-07-2013

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

BindRencolestilanEuropeMitsubishi TanabeNephrology and HepatologyPharmaceuticalPricingRegulation

US FDA accepts NDAs for Otsuka's tolvaptan and BTG's Varisolve

12-04-2013

Japanese mid-sized drugmaker Otsuka Pharmaceutical (TYO: 4578) says that the US Food and Drug Administration…

BTGCardio-vascularNephrology and HepatologyNorth AmericaOtsukaPharmaceuticalRare diseasesRegulationtolvaptanVarisolve

Positive EU regulatory news for Alexza and Ferrer, but not Gentium

22-02-2013

USA-based Alexza Pharmaceuticals (Nasdaq: ALXA) and Spanish partner Grupo Ferrer Internacional have received…

AdasuveAlexza PharmaceuticalBiotechnologydefibrotideEuropeFerrer InternacionalGentiumNephrology and HepatologyNeurologicalPharmaceuticalRegulation

Vifor Fresenius PA21 filed for approval with US FDA, accepted by EMA

11-02-2013

A New Drug Application for PA21 (iron(III)-oxyhydroxide) has been submitted to the US Food and Drug Administration.…

EuropeFreseniusGalenicaNephrology and HepatologyNorth AmericaPA21PharmaceuticalRegulationVifor Pharma

Keryx Biopharma rockets on new Zerenex data and plans to file for approval

29-01-2013

USA-based Keryx Biopharmaceuticals (Nasdaq: KERX) saw its shares close up a whopping 77% to $4.70 in…

BiotechnologyKeryx BiopharmaceuticalsNephrology and HepatologyPharmaceuticalRegulationRenagelRenvelaResearchSanofiZerenex

Novartis' Votubia cleared for non-cancerous kidney tumors in EU

05-11-2012

Swiss drug major Novartis' (NOVN: VX) shares rose 1.1% this morning, as the company revealed it has received…

EuropeNephrology and HepatologyNovartisPharmaceuticalRegulationVotubia

AVEO and Astellas file NDA for tivozanib in kidney cancer

02-10-2012

USA-based AVEO Oncology (Nasdaq: AVEO) and Japanese drug major Astellas Pharma (TSE:4503) have submitted…

Astellas PharmaAVEO OncologyBiotechnologyNephrology and HepatologyNorth AmericaOncologyPharmaceuticalRegulationtivozanib

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