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


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


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

BiotechnologyKeryx BiopharmaceuticalsNephrology and HepatologyPharmaceuticalRegulationRenagelRenvelaResearchSanofiZerenex

Alfa Wassermann and Norgine's Targaxan gets first European launch, in UK


Following recent European Union approval (The Pharma Letter December 9, 2012), Netherlands-based Norgine…

Alfa WassermannEuropeMarkets & MarketingNephrology and HepatologyNorginePharmaceuticalTargaxanXifaxan

Japan launches for Lotriga and Argamate


Norway's Pronova BioPharma (OSE: PRON.OL), recently the subject of a $845 million takeover bid from Germany's…

ArgamateAstellas PharmaCardio-vascularLotrigaMarkets & MarketingNephrology and HepatologyNorth AmericaPharmaceuticalPronova BioPharmaSanwa KagakuTakeda Pharmaceuticals

OPKO Health inks deal to acquire Cytochroma and two Ph III products


Privately-held Canadian company Cytochroma says that it has entered into a definitive agreement to be…

AlpharenCytochromaMergers & AcquisitionsNephrology and HepatologyOPKO HealthPharmaceuticalReplidea

Baxter to expand renal therapies range with $4 billion buy of Gambro


Confirming recent rumors and speculation, Baxter International (NYSE:BAX ) said yesterday it has entered…

Baxter InternationalGambroMergers & AcquisitionsNephrology and HepatologyPharmaceutical

ASN meeting highlights Otsuka's tolvaptan' Alexion's Solaris and Roche's aleglitazar research


Japan's Otsuka Pharmaceutical (TYO: 4768) that the clinical trial results for tolvaptan, an investigational…

aleglitazarAlexion PharmaceuticalsNephrology and HepatologyOtsukaPharmaceuticalResearchRocheSolaristolvaptan

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


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

EuropeNephrology and HepatologyNovartisPharmaceuticalRegulationVotubia

Amgen and KPCB to create Atara Biotherapeutics; Banner Pharmacaps changes hands


The world's largest biotech firm Amgen (Nasdaq: AMGN) and venture capital group Kleiner Perkins Caufield…

AmgenAtara BiotherapeuticsBanner PharmacapsBiotechnologyLicensingMergers & AcquisitionsNephrology and HepatologyOncologyPatheonPharmaceuticalProduction

US nephrologists expect rapid adoption of USA's first biosimilars - epoetin alfa


More than 60% of surveyed nephrologists in the USA expect to begin prescribing biosimilar epoetin alfa…

BiotechnologyDiabetesGenericsMarkets & MarketingNephrology and Hepatology

AVEO and Astellas file NDA for tivozanib in kidney cancer


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

Astellas PharmaAVEO OncologyBiotechnologyNephrology and HepatologyNorth AmericaOncologyPharmaceuticalRegulationtivozanib

Pfizer says Torisel combo fails in Ph III for kidney cancer


In a second research disappointment within a matter of days, US drugs behemoth Pfizer (NYSE: PFE) revealed…

AvastinNephrology and HepatologyOncologyPfizerPharmaceuticalResearchTorisel

Takeda and Affymax in supply deal for Omontys injection with US Renal Care


Japan's largest drugmaker Takeda Pharmaceuticals (TYO: 4502) and Affymax (Nasdaq: AFFY) have said that…

AffymaxMarkets & MarketingNephrology and HepatologyNorth AmericaOmontysPharmaceuticalTakeda Pharmaceuticals

Japanese filings for Shionogi's metreleptin and Otsuka's tolvaptin


Japanese drugmaker Shionogi (TYO: 4507) said last week that it has filed a New Drug Application with…

Asia-PacificmetreleptinNephrology and HepatologyOtsukaPharmaceuticalRare diseasesRegulationSamscaShionogitolvaptin

Regulatory filing preparations underway for Vifor's PA21 on good Ph III results


The pivotal Phase III clinical study shows that the new phosphate binder PA21 successfully controls hyperphosphatemia…

FreseniusGalenicaNephrology and HepatologyPA21PharmaceuticalRegulationResearchVifor Pharma

Astellas debuts Kiklin capsules, for hyperphosphatemia, in Japan


Japanese drug major Astellas Pharma (TYO: 4503) yesterday launched Kiklin capsules 250mg (bixalomar)…

Asia-PacificAstellas PharmaKiklinMarkets & MarketingNephrology and HepatologyPharmaceuticalSanwa Kagaku

Amgen's Sensipar/Mimpara fails to meet endpoint in CV events for dialysis patients


Amgen (Nasdaq: AMGN), the world's largest independent biotech company, announced top-line results on…

AmgenBiotechnologyCardio-vascularMimparaNephrology and HepatologyResearchSensipar

Pharma scrambling to expand gout treatment market


Joint pain caused by gout may be on its way out, as the ever-expanding market encourages the discovery…

Anti-Arthritics/RheumaticsMarkets & MarketingNephrology and HepatologyPharmaceuticalResearch

Erythropoietin market in Japan to reach $1.54 billion by 2015


The erythropoietin market in Japan is forecast to reach $1.54 billion by 2015 by analysts at TechNavio.…

Asia-PacificBiotechnologyGenericsMarkets & MarketingNephrology and HepatologyPatents

Pfizer's Torisel fails in Ph III advanced renal cell cancer study


There was disappointment for global pharma behemoth Pfizer (NYSE: PFE) when it said that the Phase III…

BayerNephrology and HepatologyNexavarOncologyPfizerPharmaceuticalResearchTorisel

Abbott Labs acquires drug candidate from Action Pharma


US health care group Abbott Laboratories (NYSE: ABT) and Action Pharma A/S, a privately-owned company…

Abbott LaboratoriesAction PharmaLicensingNephrology and HepatologyPharmaceuticalZealand Pharma

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