In the podcast series, Thermo Fisher Scientific’s Sr. Product Manager, Linas Pupelis, will discuss latest development of critical raw materials required to support the synthesis of mRNA for therapeutic development. Today, mRNA therapies are one of the hottest drug classes and the development of an entirely new drug class is not without challenges. A major issue in this industry is lack of high-quality raw material that meet clinical research and manufacturing regulations. In this podcast, we will discuss how our TheraPure reagents, which is specifically designed and carefully manufactured following the principles of 21 CFR 210/211 and ICH Q7, can help build the solutions to today’s challenges.
Nathan Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
The FDA launches a new rare disease development initiative, BioNTech’s BNT113 misses a progression-free survival endpoint, and Viking Therapeutics begins Phase III trials of its oral obesity candidate.
As ArsenalBio, TScan, Bristol Myers Squibb, and others abandon ex vivo programs for in vivo engineering, early clinical data and platform differences point to both the promise and the unresolved safety, manufacturing, and regulatory questions of generating CAR-T cells inside the body.
Viking Therapeutics has started two Phase 3 trials of once-daily oral VK2735, a dual GLP-1/GIP receptor agonist, in adults with obesity, with and without type 2 diabetes.
The FDA has accepted Pierre Fabre Pharmaceuticals’ resubmitted BLA for tabelecleucel, an allogeneic T-cell immunotherapy for EBV+ post-transplant lymphoproliferative disease. The FDA’s target action date is March 31, 2027.
