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AGC Biologics Enters into Commercial Manufacturing Agreement with Horizon Pharma plc

May 4, 2018
AGC Biologics announced it has entered into an agreement with Horizon Pharma plc for commercial supply of teprotumumab, a monoclonal antibody biologic for the treatment of…
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Novartis receives FDA approval of Tafinlar + Mekinist for adjuvant treatment of BRAF V600-mutant…

May 4, 2018
Novartis announced that the US Food and Drug Administration (FDA) has approved Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients…
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AbbVie Submits Application to EMA for Investigational Treatment Risankizumab for Moderate to Severe…

May 4, 2018
AbbVie announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for risankizumab, an investigational interleukin-23 (IL-23)…
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Bavarian Nordic receives FDA Orphan Drug Designation for BN-Brachyury for the treatment of Chordoma

May 4, 2018
Bavarian Nordic A/S announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company’s novel cancer vaccine BN-Brachyury for the treatment…
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Merck KGaA, Darmstadt, Germany to Develop Abituzumab in Metastatic Colorectal Cancer with SFJ…

May 4, 2018
Merck KGaA, Darmstadt, Germany announced a development agreement for investigational molecule abituzumab with SFJ Pharmaceuticals Group (SFJ), a US-based company focused on increasing…
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Haselmeier and Common Sensing Enter Connected Injectable Medicine Collaboration

May 3, 2018
Haselmeier, a Swiss-based developer and manufacturer of innovative self-injection devices, and Common Sensing, a Cambridge-based smart injector monitoring and support solutions company,…
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5 Benefits of Risk-Based Monitoring (RBM) Within Clinical Trials

May 3, 2018
Risk-Based Monitoring is a procedure which ensures the quality of a clinical trials study by identifying, monitoring and mitigating the risks that could affect the safety of a study.…
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Janssen to Acquire BeneVir Biopharm to Advance Immunotherapy Regimens

May 3, 2018
Janssen Biotech announced that it has entered into a definitive agreement under which it will acquire BeneVir Biopharm, Inc. (BeneVir), a privately-held, biopharmaceutical company…
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Cirius Therapeutics Reaches Enrollment Target in Phase 2b EMMINENCE Trial in NASH

May 3, 2018
Cirius Therapeutics announced that it has reached its enrollment target in its Phase 2b EMMINENCE trial for its lead program MSDC-0602K in more than 380 patients with NASH and liver…
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OnKure Close $7M Series A Financing to Support Development of Epigenetics Drug

May 3, 2018
OnKure, Inc., the epigenetics-focused drug discovery and development company that is advancing the first Largazole-derived, histone deacetylase inhibitor into Phase 1 clinical trials,…
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