US FDA grants priority review status to Novartis’ sickle cell molecule crizanlizumab
Posted on17 Jul 2019
Tagscrizanlizumab, MAB, monoclonal antibody, priority review, Priority Review Designation, USFDA Priority Review
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Novartis announced the US Food and Drug Administration (FDA) accepted the company’s Biologics License Application (BLA) and has granted Priority Review for... Read More
Roche to launch emicizumab (Hemlibra) in India for people with haemophilia A on World Haemophilia Day
Roche announced that emicizumab (Hemlibra) has been approved in India for haemophilia A with factor VIII inhibitors. It is indicated as a... Read More
New Brand Launch: Biocon introducing KRABEVA, a biosimilar Bevacizumab
Posted on24 Nov 2017
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Biocon Ltd, Asia’s premier biopharmaceuticals company, has launched KRABEVA, a biosimilar Bevacizumab for the treatment of patients with metastatic colorectal cancer and... Read More
European approval for Roche’s tocilizumab for the treatment of giant cell arteritis (GCA)
Roche, a global pioneer in pharmaceuticals and diagnostics company, announced that the European Commission (EC) has approved Actemra/RoActemra (tocilizumab) for the treatment... Read More
Sun Pharma submitted BLA in USFDA for tildrakizumab to treat plaque psoriasis
Sun Pharmaceutical Industries Ltd, announced the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for tildrakizumab. The... Read More
Otsuka and Teva Sign Licensing Agreement for Japan for Fremanezumab
Posted on15 May 2017
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Otsuka Pharmaceutical Co., Ltd and Teva Pharmaceutical Industries, Ltd. announce an agreement covering Japan for Otsuka to develop and commercialize Teva’s investigational drug candidate fremanezumab... Read More
Sanofi Pasteur, MedImmune (global biologics R&D arm of AstraZeneca) to Partner on Phase II-Stage mAb against RSV in Infants
Posted on03 Mar 2017
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Sanofi Pasteur and MedImmune, the global biologics R&D arm of AstraZeneca, agreed to a potentially €615 million (approximately $649 million) collaboration to... Read More
US FDA accepts AstraZeneca’s BLA for durvalumab in bladder cancer
AstraZeneca and its global biologics research and development arm, MedImmune, announced that the US Food and Drug Administration (FDA) has accepted the... Read More
Alder BioPharmaceuticals Licenses Clazakizumab Rights to Vitaeris
Posted on08 May 2016
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Alder BioPharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, and Vitaeris Inc., a newly formed company that will pursue innovative... Read More