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Sunovion receives FDA approval for Lonhala Magnair Inhalation Solution to Treat COPD

Dec 6, 2017
Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for Lonhala Magnair (glycopyrrolate) Inhalation Solution…
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New Confirmed Delegates & Speakers for RNA Therapeutics

Dec 6, 2017
SMi are thrilled to welcome Dr. James Hamilton, Vice President, Head of Clinical Development, Arrowhead Pharmaceuticalsonto the speaker panel RNA Therapeutics 2018! Dr. James…
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Lilly initiates clinical trial to evaluate the functionality and safety of its AID System

Dec 5, 2017
Yesterday marked dosing of the first patient with type 1 diabetes in a feasibility study to evaluate the functionality and safety of an automated insulin delivery (AID) system in…
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EMA accepts marketing application for Trastuzumab and Pegfilgrastim

Dec 4, 2017
Mylan and Biocon announced that the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Applications (MAA) for proposed biosimilar trastuzumab and…
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Andrew Hopkins, Chief Executive at Exscientia to discuss the role of Artificial Intelligence in…

Nov 30, 2017
SMi reports: Andrew Hopkins, Chief Executive at Exscientia to discuss the role of Artificial Intelligence in small molecule drug discovery at SMi’s Drug Discovery conference in March…
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GSK submits US regulatory application for single-dose tafenoquine for P. vivax malaria

Nov 30, 2017
GSK and Medicines for Malaria Venture (MMV) announced the submission of a new drug application (NDA) by GSK to the United States Food and Drug Administration (FDA), seeking approval of…
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Titan Pharmaceuticals Partners with Molteni to Market Probuphine in Europe

Nov 30, 2017
Titan Pharmaceuticals announced that it has entered into a binding term sheet with L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., pursuant to which the parties…
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BIOCAD Launches the New Manufacturing Site in North Africa

Nov 30, 2017
Russian biotechnology company BIOCAD and Moroccan pharmaceutical company Sothema Labs announced the launch of medicines derived using the technology provided by the Russian manufacturer…
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FDA Renews and Expands Its Portfolio of Simcyp Simulator (PBPK) Licenses

Nov 29, 2017
Certara announced that the US Food and Drug Administration (FDA) has greatly expanded its use of Certara’s PBPK Simcyp® Population-based Simulator and its Pediatric and Cardiac Safety…
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Sobi receives approval for Orfadin (nitisinone) Oral Suspension for the Treatment of HT-1

Nov 29, 2017
Sobi has received approval from Health Canada for an oral suspension formulation of Orfadin® (nitisinone). Orfadin is the first medicine approved in multiple countries globally for use…
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