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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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