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

FDA backs Affymax and Takeda drug Omontys for anemia due to CKD


The US Food and Drug Administration yesterday approved Omontys (peginesatide, formerly known as Hematide)…

AffymaxBiotechnologyNephrology and HepatologyNorth AmericaOmontyspeginesatidePharmaceuticalRegulationTakeda Pharmaceuticals

US FDA mixed views on Vytorin and Zetia


US drug giant Merck & Co (NYSE: MRK) yesterday received Food and Drug Administration approval to update…

Cardio-vascularMerck & CoNephrology and HepatologyNorth AmericaPharmaceuticalRegulationVytorinZetia

Back to top