Drug Research
Proprietary Nasal Delivery Formulation of Diazepam Developed by Particle Sciencesโ Reaches NDA
Proprietary nasal delivery formulation of diazepam for the treatment of epilepsy developed by CDMO, Particle Sciences, a Lubrizol LifeSciences company, has been submitted as a New Drug Application (NDA) to the U.S. FDA by San-Diego-based Neurelis Inc. ...
Drug Research
Celerion Expands NASH Biomarkers Services With the Implementation of FibroScan
Celerion, a leader in early clinical research, is pleased to announce the implementation of FibroScanยฎ to complement a suite of soluble biomarkers Celerion has validated to support nonalcoholic steatohepatitis (NASH) clinical studies. This combined approach enables Celerion to provide...
Drug Research
AbbVie to Assume Full Development and Commercial Control of Cystic Fibrosis Research Program
AbbVie ,a research-based global biopharmaceutical company, announced that it will assume full development and commercial responsibility for its collaboration with Galapagos to discover and develop new therapies to treat cystic fibrosis (CF). AbbVie's research program aims...
Drug Research
Arzeda Leverages Scalable Synthetic Biology Resources to Drive Computational Protein Design Platform
Arzeda, the Protein Design Compan, Twist Bioscience Corporation, TeselaGen Biotechnology Inc. and Labcyte Inc. have partnered to build a state-of-the-art DNA assembly platform to significantly reduce the time and cost required to build genes encoding Arzedaโs designed proteins.
The customized...
Articles
DSCSA one-month countdown
From 27 November 2018, the Drug Supply Chain Security Act (DSCSA) will be actively enforced by regulators in the US. Here, leaders from across the pharmaceutical sector discuss the industryโs readiness and what companies should be...
Drug Research
Collaboration to identify biomarkers that predict therapeutic response
The National Center for Tumor Diseases (NCT) Heidelberg and Protagen AG announced a collaboration to utilize Protagenโs Cancer Immunotherapy Array to identify biomarkers that predict therapeutic response and the incidence of immune-related adverse events (irAEs) in urothelial carcinoma patients...
Articles
Is the market now DSCSA ready?
Roundtable questionsIn November 2017, the pharma industry was granted an extension of the Drug Supply Chain Security Act (DSCSA) enforcement date to November 2018. Regulators told the market that they would not actively enforce the new serialization requirements until...
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