MASSBIOLOGICS | MedPath

Navigating the Regulatory Landscape of Cell and Gene Therapies in the EU and UK

7 months ago

• Cell and gene therapies (CGTs) are emerging as paradigm-shifting tools, offering potential cures for life-threatening diseases with single-dose treatments. • Regulatory frameworks in the EU and UK are evolving to accommodate the unique complexities of CGTs, including the use of human tissues and genetic material. • Challenges remain in scaling up manufacturing, navigating multi-authority regulations, and addressing pricing and reimbursement for these innovative therapies. • Harmonized and streamlined regulatory pathways are crucial for ensuring CGT development, patient access, and maintaining competitiveness in the EU and UK.

Pfizer and Valneva's Lyme Disease Vaccine Candidate Enters Phase 3 Trial

3 years ago

• Pfizer and Valneva have initiated a Phase 3 clinical trial for their Lyme disease vaccine candidate, VLA15, in areas highly endemic for the disease. • The VLA15 vaccine aims to protect individuals as young as five years old and targets an outer surface protein of the Borrelia bacteria. • This trial includes approximately 6,000 participants in the U.S. and Europe and could lead to regulatory authorization as early as 2025. • The vaccine is similar to the previous LYMERix vaccine but omits a protein region that some attributed to adverse events.

Lyme PrEP: Novel Monoclonal Antibody Treatment Enters Human Clinical Trials

4 years ago

• MassBiologics of UMass Medical School has initiated the first human clinical trial of Lyme PrEP, a pre-exposure prophylaxis using a single monoclonal antibody that could prevent Lyme disease. • The trial has enrolled 66 volunteers in Nebraska to evaluate safety and pharmacology, with researchers hoping to determine how long the protective antibody remains in circulation after administration. • Unlike traditional vaccines, Lyme PrEP provides immediate protection upon injection and targets Borrelia bacteria in tick guts before transmission, potentially offering a solution to a disease that affects approximately 476,000 Americans annually.