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1 to 25 of 2522 results

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

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

Shire files for US approval of Lifitegrast for dry eye disease

02-03-2015

Ireland-based drugmaker Shire has submitted a New Drug Application with the US Food and Drug Administration…

BiotechnologyEBI-005Eleven BiotherapeuticsLifitegrastOphthalmicsRegulationShireUSA

Celgene’s Abraxane gains new indication in Europe

02-03-2015

The European Commission has approved US biotech firm Celgene’s Abraxane (paclitaxel formulated as albumin-bound…

AbraxaneBiotechnologyCelgene CorpEuropeOncologyRegulation

Amgen's Kyprolis doubles progression-free survival in head-to-head against Velcade

Amgen's Kyprolis doubles progression-free survival in head-to-head against Velcade

02-03-2015

USA-based biotech firm Amgen and its subsidiary Onyx Pharmaceuticals have announced the interim results…

AmgenBiotechnologyKyprolisOncologyResearchUSAVelcade

National Institute of Allergy and Infectious Diseases launches ZMapp Ebola trial with Liberia

National Institute of Allergy and Infectious Diseases launches ZMapp Ebola trial with Liberia

02-03-2015

The USA’s National Institute of Allergy and Infectious Diseases has launched a clinical trial with…

Anti-viralsBiotechnologyLiberiaMapp BiopharmaceuticalResearchZMapp

Amarin in deal with Eddingpharm to commercialize Vascepa in China

Amarin in deal with Eddingpharm to commercialize Vascepa in China

28-02-2015

US biotech firm Amarin has entered into an exclusive agreement for Chinese drugmaker Eddingpharm to develop…

AmarinBiotechnologyCardio-vascularChinaEddingpharmLicensingVascepa

1 to 25 of 2522 results

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