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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

NICE draft guidance backs Gilead’s Harvoni for treating chronic hepatitis C

NICE draft guidance backs Gilead’s Harvoni for treating chronic hepatitis C

03-03-2015

The National Institute for Health and Care Excellence (NICE), the medicines cost watchdog for England,…

Anti-viralsBiotechnologyGilead SciencesHarvoniPricingRegulationUK

Interview: Boehringer Ingelheim's Heidi Hunter on biosimilar originality, jousting and getting to market

Interview: Boehringer Ingelheim's Heidi Hunter on biosimilar originality, jousting and getting to market

02-03-2015

German family-owned drug major Boehringer Ingelheim has been in the biosimilars business since the end…

BiosimilarsBiotechnologyBoehringer IngelheimGermanyHeidi HunterInterviews

Positive Ph III results for Portola’s Xarelto antidote andexanet alfa

02-03-2015

USA-based Portola Pharmaceuticals saw its shares jump 7.2% to $40.83 after it announced positive results…

andexanet alfaBayerBiotechnologyCardio-vascularPortola PharmaceuticalsRegulationResearchUSA

Jeff Barrett named founding director of Centre for Therapeutic Target Validation with GSK and Wellcome

Jeff Barrett named founding director of Centre for Therapeutic Target Validation with GSK and Wellcome

02-03-2015

Jeffrey Barrett has been appointed the founding director for the Centre for Therapeutic Target Validation,…

BiotechnologyBoardroomCentre for Therapeutic Target ValidationGlaxoSmithKlineUK

Boehringer Ingelheim files BLA with FDA for Pradaxa antidote idarucizumab

02-03-2015

German family-owned pharma major Boehringer Ingelheim has submitted a Biologics License Application (BLA)…

BiotechnologyBoehringer IngelheimCardio-vascularidarucizumabPradaxaRegulationUSA

Amgen licenses AMG 714 to start-up Celimmune

Amgen licenses AMG 714 to start-up Celimmune

02-03-2015

USA-based biotech company Amgen has licensed a Phase II-stage anti-IL-15 monoclonal antibody, AMG 714,…

AmgenBiotechnologyGastro-intestinalsImmunologicalsLicensingUSA

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