Aligning mRNA Progress with Regulatory Streamlining
PackGene Forms Global Alliance with Non-Profit GC4K and Weill Cornell Medicine for Gene Therapy Treatment for Rare Neurological Disease
Under a global alliance with the Australian non-profit GC4K and Weill Cornell Medicine, PackGene aims to deliver a custom-tailored gene therapy solution for hereditary spastic paraplegia type 56, an exceptionally rare neurological disease.
Bora Biologics to Support DotBio’s Novel Antibody Against Cancer Targets
Bora said it will be involved in stages ranging from chemistry, manufacturing, and controls strategy through to clinical development.
Coave Announces €32 Million in Funding for Next-Gen Genetic Medicines
The co-leaders of the financing were Novo Holdings and Bpifrance, with other investments from Invus, UI Investissement, Seroba Life Sciences, Fund+, Kurma Partners, Omnes Capital, and Turenne Capital.
Final Thoughts and Looking Forward: The Future of Pandemic Preparedness
Sustained investment, technological innovation, and collaboration are essential to future pandemic preparedness.
Vaccine Nationalism and Global Health Interdependence
Strategies to combat vaccine hesitancy and ensure equitable global vaccine distribution are explored amidst declining confidence.
Spark Risk: Improving Pandemic Sentinel Warnings
Advances in surveillance, including AI and wastewater monitoring, are critical to detecting and responding to emerging pathogens.
Capacity and Surge Response Leading Into a State of Readiness
Sustaining pandemic readiness requires investment in workforce, infrastructure, and scalable manufacturing practices.
Empowering Informed Decisions: Tools for Navigating Public Health Challenges
Empowering the public with balanced information and enhancing agency alignment are central to navigating public health crises effectively.
An All-Government Approach: Recognizing the Benefits and Drawbacks
The panel covers the benefits and challenges of a unified government pandemic response, focusing on transparency and trust-building.
Reflecting on the COVID-19 Pandemic Response
Lessons from the COVID-19 response highlight regulatory collaboration, research expansion, and challenges in vaccine access and preparedness.
Pandemic Defense Strategies: Panel Introductions and Discussion Overview
The panelists introduce themselves and outline key aspects of pandemic preparedness, emphasizing global collaboration and coordinated responses.
FDA Grants Orphan Drug Designation to Cour Pharmaceuticals’ PBC Treatment
CNP-104 is a biodegradable nanoparticle that previously received fast track designation from FDA in January 2022, which would eventually make it eligible for accelerated approval and priority review.
FDA Fast Tracks J&J’s Posdinemab for Alzheimer’s Disease
This latest fast track designation marks the second such designation by FDA for J&J’s tau-directed investigational therapies for treating Alzheimer’s disease.
Two Guidance Documents, One Final, Published by FDA
The final guidance is a revision of a policy that has existed in some form since at least 2009, while a separate, draft guidance will accept public comment for consideration for its final version through April 8.
Argobio and University of Southern Denmark Launch Inverna Therapeutics, a Next-Generation RNA Company
The new company will harness splicing technology to innovate safer and more effective RNA therapies for severe genetic diseases.
