Pharmaceutical - Pharmaceutical, North America, Astellas Pharma

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Astellas and Medivation file sNDA for new Xtandi indication

Astellas and Medivation file sNDA for new Xtandi indication


Japanese drug major Astellas Pharma and US partner Medivation have filed a supplemental New Drug Application…

Astellas PharmaMedivationNorth AmericaOncologyPharmaceuticalRegulationUSAXtandi

Cumberland Pharma acquires Vaprisol from Astellas


USA-based Cumberland Pharmaceuticals says it has acquired from the US subsidiary of Japan’s Astellas…

Astellas PharmaCumberland PharmaceuticalsHematologyLicensingNorth AmericaPharmaceuticalUSAVaprisol

Astellas amends license deal for isavuconazole with Basilea


Japanese drug major Astellas Pharma has amended the license, co-development and co-promotion agreement…

Antibiotics and Infectious diseasesAstellas PharmaBasilea PharmaceuticaCanadaisavuconazoleLicensingNorth AmericaPharmaceuticalUSA

Prostate cancer market set to grow 50% by 2021: report


The increasing number of sufferers and the uptake of new drugs will see the prostate cancer market grow…

Asia-PacificAstellas PharmaEuropeJohnson & JohnsonMarkets & MarketingNorth AmericaOncologyPharmaceuticalXtandiZytiga

Theravance reintroduces Vibativ in USA


US drug developer Theravance (Nasdaq: THRX) says it has commenced shipments of Vibativ (telavancin) into…

Antibiotics and Infectious diseasesAstellas PharmaMarkets & MarketingNorth AmericaPharmaceuticalProductionTheravanceVibativ

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

FDA backs Astellas' Astragraf XL for kidney transplant rejection prophylaxis


The US Food and Drug Administration has approved Japanese drug major Astellas Pharma's (TYO: 4503) Astragraf…

Astellas PharmaAstragraf XLImmunologicalsNorth AmericaPharmaceuticalRegulationtacrolimus

Briefs: Boehringer files Pradaxa for DVT and PE; Astellas' Mycamine pediatric approval; Simcere divests Boda


Family-owned German drug major Boehringer Ingelheim has submitted an application to the European Medicines…

Antibiotics and Infectious diseasesAstellas PharmaBoehringer IngelheimCardio-vascularEuropeJilin BodaMergers & AcquisitionsNorth AmericaPharmaceuticalRegulationSimcere PharmaceuticalYidashen

Negative FDA news for AVEO's tivozanib and Dynavax' hep B vaccine


US biotech firm AVEO Oncology (Nasdaq: AVEO) says that it has received a complete response letter from…

Anti-viralsAstellas PharmaAVEO OncologyBiotechnologyDynavax TechnologiesHeplisavNorth AmericaOncologyPharmaceuticalRegulationtivozanibVaccines

AbbVie/Eisai's Humira has best clinical profile among psoriatic arthritis treatments


Based on clinical data and the opinions of interviewed thought leaders interviewed by health care advisory…

AbbVieAnti-Arthritics/RheumaticsAstellas PharmaBiotechnologyCimziaEisaiEuropeHumiraMarkets & MarketingNorth AmericaPharmaceuticalUCB

Fast FDA approval for Bayer's new drug for advanced prostate cancer, Xofigo


The US Food and Drug Administration yesterday (May 15) approved Xofigo (radium Ra 223 dichloride, initially…

AlgetaAstellas PharmaBayerNorth AmericaOncologyPharmaceuticalRegulationXofigo

Six months post launch, US prescribing trends for Xtandi


At six months following launch of Xtandi (Astellas Pharma/Medivation's enzalutamide), surveyed urologists…

3MAstellas PharmaJevtanaJohnson & JohnsonMarkets & MarketingMedivationNorth AmericaOncologyPharmaceuticalSanofiXtandiZytiga

FDA advisory votes against AVEO and Astellas' cancer drug tivozanib


US biotech firm AVEO Oncology (Nasdaq: AVEO) saw its shares plunge as much as 57% in late trading yesterday…

Astellas PharmaAVEO OncologyBiotechnologyNorth AmericaOncologyPharmaceuticalRegulationtivozanib

Advantages of Tivopath over currently used kidney cancer therapies seen by thought leaders


US and European oncologists surveyed by health care advisory firm Decision Resources agree that a therapy's…

Astellas PharmaAVEO OncologyBiotechnologyBristol-Myers SquibbEuropeInlytaKyowa Hakko KirinMarkets & MarketingnivolumabNorth AmericaOncologyPfizerPharmaceuticalTivopathtivozanib

BioTrends views Xeljanz and Zytiga prescribing in USA


After around two months on the market, 37% of US rheumatologists have prescribed Pfizer's (NYSE: PFE)…

Anti-Arthritics/RheumaticsAstellas PharmaBiotechnologyJevtanaJohnson & JohnsonMedivationNorth AmericaOncologyPfizerPharmaceuticalSanofiXeljanzXtandiZytiga

Regulatory briefs from Astellas, Janssen, Biogen and Elan, and QRxPharma


The US subsidiary of Japanese drug major Astellas Pharma (TYO: 4503) says the US Food and Drug Administration…

Anti-viralsAstellas PharmaBiogen IdecBiotechnologyElanEuropeJanssenJohnson & JohnsonMoxDuoNeurologicalNorth AmericaOncologyPharmaceuticalPrezistaQRxPharmaRegulationTarcevaTysabri

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

Regulatory briefs from Ipsen/Inspiration, Janssen and Astellas


French drugmaker Ipsen (Euronext: IPN) and partner USA-based privately-held Inspiration Biopharmaceuticals…

Astellas PharmaBiotechnologyEuropeInspiration BiopharmaceuticalsIpsenJanssen-CilagJohnson & JohnsonNorth AmericaOBI-1OncologyPharmaceuticalRegulationTarcevaZytiga

Reimbursement barriers a factor that strongly constrains Zytiga prescribing in USA


In a little more than a year after its launch, a sizeable proportion of surveyed US oncologists indicate…

Astellas PharmaJanssenJohnson & JohnsonMarkets & MarketingMedivationNorth AmericaOncologyPharmaceuticalPricingXtandiZytiga

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

Medivation and Astellas debut Xtandi in USA


USA-based Medivation (Nasdaq: MDVN) and Japanese partner Astellas Pharma (TSE: 4503) yesterday announced…

Astellas PharmaenzalutamideMarkets & MarketingMedivationNorth AmericaOncologyPharmaceuticalXtandi

FDA backs Medivation and Astellas' prostate cancer drug Xtandi


USA-based Medivation (Nasdaq: MDVN and Japanese drug major Astellas Pharma (TYO: 4503) say that the US…

Astellas PharmaBiotechnologyenzalutamideMedivationNorth AmericaOncologyPharmaceuticalRegulationXtandi

FDA approves Astellas' Myrbetriq for overactive bladder


The US Food and Drug Administration has approved Japanese drug major Astellas Pharma's (TYO: 4503) Myrbetriq…

Astellas PharmaGenito-urinarymirabegronMyrbetriqNorth AmericaPharmaceuticalRegulation

Expanded Access Program for enzalutamide agreed with US FDA


The US Food and Drug Administration agreed that Medivation (Nasdaq: MDVN) and Japanese drug major Astellas…

Astellas PharmaBiotechnologyenzalutamideMDV3100MedivationNorth AmericaOncologyPharmaceuticalRegulation

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