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FDA accepts Bayer's BLA for hemophilia A agent Kovaltry

FDA accepts Bayer's BLA for hemophilia A agent Kovaltry

04-03-2015

The US Food and Drug Administration has accepted German pharma major Bayer’s Biologics License Application…

BAY 81-8973BayerBiotechnologyHematologyKovaltryRegulationUSA

arGEN-X exercises option on ARGX-115 to target immune checkpoint in cancer

arGEN-X exercises option on ARGX-115 to target immune checkpoint in cancer

04-03-2015

Clinical-stage biopharma company arGEN-X has exercised its option to exclusively license preclinical…

arGEN-XBelgiumBiotechnologyLicensingOncology

Bristol-Myers will lead immuno-oncology market in 2022, say analysts

Bristol-Myers will lead immuno-oncology market in 2022, say analysts

04-03-2015

Analysts at Morningstar Equity Research see significantly more opportunity than the overall market for…

AstraZenecaBiotechnologyBristol-Myers SquibbMarkets & MarketingMerck & CoOncologyOpdivoResearchRoche

FDA formally accepts Actelion's NDA for Uptravi

FDA formally accepts Actelion's NDA for Uptravi

04-03-2015

Switzerland-based Actelion, Europe’s largest biotech company, says that the US Food and Drug Administration…

ActelionBiotechnologyRegulationRespiratory and PulmonaryselexipagUptraviUSA

Bavarian Nordic set to earn $975 million in Prostvac deal

Bavarian Nordic set to earn $975 million in Prostvac deal

04-03-2015

Danish biotech firm Bavarian Nordic has granted US pharma major Bristol-Myers Squibb an exclusive option…

Bavarian NordicBiotechnologyBristol-Myers SquibbLicensingOncologyProstvacVaccinesYervoy

Islet Sciences gains certain rights for Phase II SGLT2 inhibitor remogliflozin

Islet Sciences gains certain rights for Phase II SGLT2 inhibitor remogliflozin

03-03-2015

US biotech firm Islet Sciences has entered into a license agreement with Brighthaven Ventures (BHV) for…

BiotechnologyBrighthaven VenturesDiabetesIslet SciencesLicensingNephrology and Hepatologyremogliflozin

Oncolytics Biotech gains third orphan status for Reolysin

Oncolytics Biotech gains third orphan status for Reolysin

03-03-2015

Canada’s Oncolytics Biotech revealed today that the US Food and Drug Administration has granted Orphan…

BiotechnologyOncologyOncolytics BiotechRare diseasesRegulationReolysinUSA

Cardio3 BioSciences milestone in regulatory path for C-Cure registration in EU

Cardio3 BioSciences milestone in regulatory path for C-Cure registration in EU

03-03-2015

Belgian cell therapy specialist Cardio3 BioSciences has received a Pediatric Investigation Plan (PIP)…

BiotechnologyC-CureCardio-vascularCardio3 BioSciencesEuropeRegulation

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