FDA puts Altimmune's intranasal COVID-19 vaccine trial on hold Ascendis files IND for sustained-release, anti-cancer TLR drug Nanoparticle drug delivery shows promise in brain injuries Tonix deal sets up use of intranasal drug in diabetes, obesity Becton Dickinson, ramping up syringe capacity, set to turn out 1B COVID-19 vaccine devices by year-end New drug approvals hit a high note in 2020 but face uncertainty in 2021 Featured Story | By Nick Paul Taylor The FDA has put a planned phase 1 clinical trial of Altimmune’s intranasal COVID-19 vaccine on clinical hold. Altimmune attributed the setback to the need for protocol modifications and additional chemistry, manufacturing and controls (CMC) data. read more |
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Top Stories By Nick Paul Taylor Ascendis Pharma has filed to run a clinical trial of an intratumoral, sustained-release formulation of resiquimod. The TLR agonist has shown preclinical promise as a cancer therapy, but its clinical use has been held back by tolerance, poor solubility and adverse effects associated with systemic delivery. read more By Nick Paul Taylor A nanoparticle drug delivery system designed to shuttle molecules across the blood-brain barrier has shown promise in preclinical tests. The researchers used the system to transport siRNA across the intact blood-brain barriers of mice, pointing to its potential use in the treatment of traumatic brain injury. read more By Nick Paul Taylor Tonix Pharmaceuticals has struck a licensing deal to expand use of its intranasal potentiated oxytocin into cardiometabolic syndromes. The agreement gives Tonix exclusive rights to University of Geneva technology covering oxytocin-based treatments for insulin resistance, diabetes and obesity. read more By Fraiser Kansteiner Beckton Dickinson has taken orders for more than 1 billion pandemic needles and syringes, and that's just a piece of the company's COVID-19 battle plan. Next up, BD will overhaul its prefilled syringe capacity to keep the vaccine supply chain running as mass immunization campaigns ramp up. read more By Amirah Al Idrus 2020 didn't match 2018's record-breaking performance in the new drug approvals department, but it came pretty darn close. read more Resources Sponsored By: Polpharma Biologics Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards. 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