Pharmaceutical - Pharmaceutical, North America, Nephrology and Hepatology

US orphan status for Pharmalink’s Busulipo

US orphan status for Pharmalink’s Busulipo


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

BusulipoNefeconNephrology and HepatologyNorth AmericaOncologyPharmaceuticalPharmaLinkRegulationResearch

Negative advisory view for Otsuka's tolvaptan in ADPKD


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

Nephrology and HepatologyNorth AmericaOtsukaPharmaceuticalRegulationtolvaptin

AstraZeneca to fork out $815 million for rights to anemia drug candidate


In yet another move to boost its R&D pipeline, Anglo-Swedish drug major AstraZeneca (LSE: AZN) has entered…

Asia-PacificASP1517Astellas PharmaAstraZenecaBiotechnologyFG-4592FibroGenLicensingNephrology and HepatologyNorth AmericaPharmaceuticalResearch

Vifor gains US FDA approval for Injectafer


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

FerinjectInjectaferLuitpold PharmaNephrology and HepatologyNorth AmericaPharmaceuticalRegulationVifor Pharma

Rockwell Medical leaps on Phase III study results for lead iron delivery drug


US biopharmaceutical company Rockwell Medical (Nasdaq: RMTI) has announced successful Phase III results…

Nephrology and HepatologyNorth AmericaPharmaceuticalResearch

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


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

BTGCardio-vascularNephrology and HepatologyNorth AmericaOtsukaPharmaceuticalRare diseasesRegulationtolvaptanVarisolve

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

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

FDA extends PDUFA date for Biogen Idec's MS drug BG-12; Abbott and Reata's bardoxolone stalled


Shares of US biotech firm Biogen Idec (Nasdaq: BIIB) fell 3% to $149.50 in premarket trading yesterday,…

Abbott LaboratoriesbardoxoloneBG-12Biogen IdecBiotechnologyDiabetesNephrology and HepatologyNeurologicalNorth AmericaPharmaceuticalReata PharmaceuticalsRegulationResearch

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

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

BTG debuts Voraxaze in the USA


The US subsidiary of the UK-based BTG (LSE: BGC) yesterday announced the launch of Voraxaze (glucarpidase)…

ASD HealthcareBTGMarkets & MarketingNephrology and HepatologyNorth AmericaPharmaceuticalVoraxaze

Affymax and Takeda get special Medicare code for Omontys


USA-based Affymax (Nasdaq: AFFY) and the US subsidiary of Japanese drug major Takeda Pharmaceuticals…

AffymaxBiotechnologyNephrology and HepatologyNorth AmericaOmontysOncologypeginesatidePharmaceuticalPricingRegulationTakeda Pharmaceuticals

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