US FDA issues Complete Response Lette to Takeda’s Entyvio for maintenance therapy in adults with ulcerative colitis
Takeda Pharmaceutical Company Limited received a Complete Response Letter from the US Food and Drug Administration (FDA) in response to the submission... Read More
Sandoz to commercialize proposed multiple sclerosis biosimilar natalizumab
Sandoz, a Novartis division and a global leader in biosimilars, announced that it has entered into a global commercialization agreement for a... Read More
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
Case Study: EC’s conditional marketing approval to Libtayo for advanced CSCC
Posted on02 Jul 2019
Tagscemiplimab, Conditional marketing authorisation, EU marketing authorization, Libtayo, MAB, Regeneron, Sanofi
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The European Commission (EC) has granted conditional marketing authorization for Libtayo (cemiplimab) for the treatment of adults with metastatic or locally advanced... Read More
USFDA Approves Amgen’s Trastuzumab Biosimilar, Kanjinti
The FDA has approved Amgen’s ABP 980, a trastuzumab biosimilar referencing Herceptin. The drug, trastuzumab-anns, will be sold as Kanjinti. Kanjinti was approved 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
Tildrakizumab (Ilumetri): Discovery, Development to Commercialization Case Study
Brand Name: Ilumetri Biomolecule: Tildrakizumab Tildrakizumab was designed to block interleukin-23, a cytokine that plays an important role in managing the immune... Read More
Plaque psoriasis drug Tremfya receives Australian & Brazilian approvals
MorphoSys AG, a late-stage, biopharmaceutical company, announced that country subsidiaries of its licensee Janssen reported that Tremfya (guselkumab) has been approved for... 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