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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

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

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

31-07-2013

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

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

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

12-07-2013

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

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

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

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

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

19-10-2012

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

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

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

BTG debuts Voraxaze in the USA

01-05-2012

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

16-04-2012

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

28-03-2012

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

26-01-2012

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

Cardio-vascularMerck & CoNephrology and HepatologyNorth AmericaPharmaceuticalRegulationVytorinZetia

BTG’s Voraxaze gains first approval, in USA

19-01-2012

The US Food and Drug Administration has approved UK headquartered BTG International’s (LSE: BGC)…

BiotechnologyBTGNephrology and HepatologyNorth AmericaOncologyRegulationVoraxaze

FDA committee backs Affymax CKD drug

09-12-2011

The US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted 15 to one,…

AffymaxNephrology and HepatologyNorth AmericaOncologypeginesatidePharmaceuticalRegulationTakeda Pharmaceuticals

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