Preparation and Characterization of Pregabalin Loaded Liposomes for Topical Drug Delivery: Utilizing the Novel Platform Technology for the Effective Treatment of Neuropathic Pain Management
Localized treatment approaches for diabetic neuropathic pain management, like pregabalin liposomal topical formulations, offer a novel strategy by directly targeting affected areas. Liposomes enhance skin permeability and sustain drug release, delivering pregabalin efficiently to peripheral nerves while reducing systemic exposure. In a proof-of-concept study using an IVPT and a diabetic neuropathic pain rat model, improved skin penetration and significant reductions in mechanical allodynia and thermal hyperalgesia were shown.
The FDA expanded Anktiva to BCG-unresponsive papillary-only NMIBC using existing CIS trial data, a precedent with implications for development timelines and supply planning.
Ishani Maharaj of Ingredients + Specialties from Univar Solutions explains how to stabilize GLP-1 multi-agonists, weigh delivery formats, and qualify novel excipients and suppliers.
MASH and cardiomyopathy AI collaboration: AstraZeneca pays insitro $40M upfront for target discovery, then leads clinical development and CMC planning.
Boyang Wang, Immortal Dragons, discusses how the FDA’s Expedited IND Pilot must prove efficiency as sponsors chase the fastest route to valid first-in-human data.
Nate 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’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors, CDMOs, and quality teams.