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Adocia opens US subsidiary and appoints Simon Bruce and Stephen Daly

Adocia opens US subsidiary and appoints Simon Bruce and Stephen Daly

06-03-2015

French biotech company Adocia has created a US subsidiary, Adocia Incorporated, and appointed Simon Bruce…

AdociaAdocia IncorporatedBiotechnologyBoardroomUnited States

Sandoz’s Zarxio first biosimilar to be approved under new FDA pathway

Sandoz’s Zarxio first biosimilar to be approved under new FDA pathway

06-03-2015

Sandoz, the generics unit of Swiss pharma giant Novartis, today received approval from the US Food and…

AmgenBiosimilarsBiotechnologyNeupogenNovartisOncologyRegulationSandozUSAZarxioZarzio

Megafunds could solve biotech financing and unlock new orphan drug funding

Megafunds could solve biotech financing and unlock new orphan drug funding

06-03-2015

A new financing technique could reduce the risk associated with investing in the treatment of new diseases…

BiotechnologyFinancialHealthMedicineNational Center for Advancing Translational Studies

Gates Foundation makes $52 million investment in CureVac

Gates Foundation makes $52 million investment in CureVac

06-03-2015

The Bill & Melinda Gates Foundation has committed to invest $52 million in private biopharma company…

BiotechnologyBusiness FinanceCureVacHealth Medical PharmaUnited States

Spero Therapeutics gains rights to novel anti-infectives developed at HZI

Spero Therapeutics gains rights to novel anti-infectives developed at HZI

06-03-2015

Ascenion, the technology transfer partner of Germany’s Helmholtz Center for Infection Research (HZI),…

Antibiotics and Infectious diseasesBiotechnologyLicensingResearchSpero Therapeutics

AOP Orphan updates on Phase III trial PROUD-PV applying ropeginterferon

06-03-2015

Austria-based rare diseases specialist AOP Orphan Pharmaceuticals has completed recruitment for its Phase…

AOP Orphan PharmaceuticalsBiotechnologyPharmaEssentiaRare diseasesResearchropeginterferon alfa 2b

Norgine partners with Navidea for Lymphoseek marketing in Europe

05-03-2015

Netherlands-headquartered independent drugmaker Norgine says that its affiliate, SpePharm AG, has entered…

BiotechnologyEuropeLicensingLymphoseekNavidea BiopharmaceuticalsNorgineOncology

US biosimilar approvals poised to grow, but market uptake faces challenges, says Tufts CSDD

05-03-2015

Biosimilar approvals in the USA are expected to increase during the next five years, but safety concerns…

BiosimilarsBiotechnologyFinancialMarkets & MarketingRegulationUSA

US FDA expands use of Bristol-Myers’ Opdivo to NSCLC

US FDA expands use of Bristol-Myers’ Opdivo to NSCLC

05-03-2015

The US Food and Drug Administration late yesterday expanded the approved use of pharma major Bristol-Myers…

BiotechnologyBristol-Myers SquibbOncologyOpdivoRegulationUSA

Novogen’s TRXE-009 kills brain cancer stem cells

Novogen’s TRXE-009 kills brain cancer stem cells

05-03-2015

Shares of Australian biotech company Novogen rose dramatically as it announced that one of its lead candidate…

AustraliaBiotechnologyNovogenOncologyResearch

Baxter acquires biopharmaceutical firm SuppreMol

Baxter acquires biopharmaceutical firm SuppreMol

04-03-2015

US health care product company Baxter International has acquired SuppreMol GmbH for 200 million euros…

Baxter InternationalBiotechnologyImmunologicalsSuppreMol

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

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

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

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