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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

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

28-01-2013

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

11-01-2013

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

10-01-2013

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

04-12-2012

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

05-11-2012

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

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

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

29-10-2012

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

09-10-2012

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

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

Pfizer says Torisel combo fails in Ph III for kidney cancer

13-08-2012

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

10-08-2012

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

06-08-2012

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

09-07-2012

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

26-06-2012

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

11-06-2012

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

23-05-2012

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

20-05-2012

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

17-05-2012

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

04-05-2012

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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