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Regulatory Issues for PF Syringes & Injectable Drug Devices

Nov 9, 2018
More so than ever injectable drugs are administered using devices like pre-filled syringes, auto-injectors, and pen-injectors. Patient-centricity is driving the future of the injectable…
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Genkyotex Meets Both Primary and Secondary Interim Efficacy Endpoints in Phase 2 Trial of GKT831 in…

Nov 9, 2018
Genkyotex announced that its lead product candidate GKT831, a NOX1/4 inhibitor, met both the primary and secondary interim efficacy endpoints with high statistical significance after…
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FDA Approves First Drug Using the Recombinant Factor C Assay for Endotoxin Testing

Nov 9, 2018
Lonza announced that the recombinant Factor C (rFC) Assay has been used for endotoxin testing of Eli Lilly’s Emgality (galcanezumab), the first drug approved by the U.S. Food and Drug…
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BioTime and Asterias Enter Into Definitive Merger Agreement to Create Leading Cell Therapy Company

Nov 9, 2018
BioTime and Asterias Biotherapeutics announced that they have entered into a definitive merger agreement whereby BioTime will acquire all of the remaining outstanding common stock of…
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Hikma announces global agreement with Vectura to develop generic versions of GSK’s Ellipta portfolio

Nov 9, 2018
Hikma Pharmaceuticals PLC announces that it has signed an agreement with Vectura Group plc (Vectura) for the global development and commercialisation of generic versions of…
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Sementis and Enesi Pharma partner to develop needle-free vaccines

Nov 9, 2018
Enesi Pharma, an innovative pharmaceutical company developing unique injectable solid dose drug-device vaccine products, and Sementis, a biotechnology company developing innovative…
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Amgen And Provention Bio Announce Co-Development Collaboration In Celiac Disease

Nov 9, 2018
Amgen and Provention Bio announced a licensing and co-development agreement for AMG 714, identified by Provention as PRV-015. AMG 714 is a novel anti-IL-15 monoclonal antibody being…
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Guided Therapeutics Announces Extension of Distribution Agreement for Eastern Europe and Russia

Nov 8, 2018
Guided Therapeutics announced it has signed an extension of its distribution agreement with its Russian and Eastern European Sales and Marketing partner, Newmars Group Kft. The…
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Altasciences Completes Bioanalytical Laboratory Expansion

Nov 8, 2018
Altasciences is excited to announce the completion of their laboratory expansion. The additional space will be dedicated to ligand binding and cell-based assays. Altasciences’…
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Final Reminder: 1 Week Until SMi’s Lyophilization USA

Nov 8, 2018
With the event now just 1 week away, I wanted to remind you that there is still time to secure your place at SMi's 4th annual event, Lyophilization USA, taking place on November 15th…
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