FarmaKology Newsletter - Issue #84
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China issues new guidelines to speed up novel drug development
China’s Center for Drug Evaluation (CDE), a division under the Chinese drug industry watchdog the National Medical Products Administration (NMPA), has been churning out guidelines in the past year to help the nation transform from a generics/biosimilar maker into a novel drug development hub, reports The Pharma Letter’s local correspondent. The most recent guideline was a draft for rare disease drug development issued on October 11. The draft encouraged drug developers to actively use biomarkers and model informed drug development (MIDD), which includes model-informed dosing, to largely improve clinical study efficiency.
Sage Therapeutics and Biogen Announce Plans to Submit a New Drug Application (NDA) for Zuranolone to the U.S. Food & Drug Administration in the Second Half of 2022 with Rolling Submission Expected to Start in Early 2022
Sage Therapeutics, Inc. and Biogen Inc. today announced their plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration for zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022. The planned initial submission package will seek approval of zuranolone for the treatment of major depressive disorder (MDD) and an additional filing for postpartum depression (PPD) is anticipated in the first half of 2023.
FSD Pharma Signs Agreement with Covar Pharmaceuticals to Support the Development of Lucid-PSYCH
FSD Pharma Inc., a life sciences holding company dedicated to building a portfolio of assets and biotech solutions, announced today it has entered into an agreement with Covar Pharmaceuticals Inc. , a contract development and manufacturing services organization (“CDMO”), to commence work on providing research quantities of FSD’s drug candidate, Lucid-PSYCH, on an exclusive basis for further clinical evaluation.
CareDx and Eledon Pharmaceuticals Announce Collaborative Research Agreement
CareDx, Inc. , a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, and Eledon Pharmaceuticals, Inc. , a clinical stage biopharmaceutical company developing precision therapies that target the CD40 Ligand pathway for use in organ and cellular transplantation, and for the treatment of amyotrophic lateral sclerosis (ALS) and autoimmune diseases, today announced a collaborative research agreement to use AlloSure to help assess the efficacy of Eledon’s investigational AT-1501 in the prevention of rejection in upcoming renal transplantation trials.
Research & Study
Scientists identify suspect protein as a marker for prostate cancer progression
Scientists gain new understanding of how brain cells talk
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