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. Sponsored By: Blue Matter Biopharma companies in rare diseases: How to maximize the odds of success by becoming a valued member of the unique “rare disease ecosystem.” Sponsored by: Metabolon Learn six ways metabolomics provides greater confidence, higher success rates and complements the work of your in-house teams for your drug development pipeline. Sponsored by: Covance Download the whitepaper to learn how your safety organization can implement automation technologies to enable process and cost efficiencies, improve resource allocation and ensure compliance and quality. Sponsored By: BBK Worldwide The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement. Sponsored by: Rousselot This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments. Sponsored by: Aldevron Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience. Sponsored By: Outer Edge Technology A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success. Sponsored by: Catalent In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. | 
