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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

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NICE draft guidance backs Gilead’s Harvoni for treating chronic hepatitis C

NICE draft guidance backs Gilead’s Harvoni for treating chronic hepatitis C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

EMA/CHMP backs Roche’s Avastin plus chemotherapy in advanced cervical cancer

EMA/CHMP backs Roche’s Avastin plus chemotherapy in advanced cervical cancer

28-02-2015

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a…

AvastinBiotechnologyEuropeOncologyRegulationRoche

Positive Ph III results from Biogen Idec and SOBI’s Alprolix in pediatric study

Positive Ph III results from Biogen Idec and SOBI’s Alprolix in pediatric study

28-02-2015

US biotech major Biogen Idec and Nordic drugmaker Swedish Orphan Biovitrum have announced positive top-line…

AlprolixBiogen IdecBiotechnologyEuropeHematologyRegulationResearchSobiSwedish Orphan Biovitrum

Significant drop in pharma applications to EPO shows pace of innovation is dropping

Significant drop in pharma applications to EPO shows pace of innovation is dropping

26-02-2015

The European Patent Office (EPO) has reported an increase in the number of patent filings for the fifth…

BiotechnologyEPOEuropeLegalPharmaceutical

UK doctors call for approval of off-label use of Avastin for wet-AMD

UK doctors call for approval of off-label use of Avastin for wet-AMD

25-02-2015

Doctors in the UK are calling on health ministers and NHS England to intervene to make Swiss pharma giant…

AvastinBiotechnologyHealthcareLucentisNovartisOphthalmicsPricingRegulationRocheUK

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