Oral administration is the preferred route of delivery for therapeutic molecules due to its convenience. However, most New Chemical Entities (NCE) exhibit physico-chemical properties limiting their absorption in the gastrointestinal (GI) tract, with almost 70% of identified molecules facing solubility issues in aqueous GI fluids according to Pharmacircle data from March 2022. Lipid-based formulations (LBF) is an interesting approach to enhance oral bioavailability of poorly water-soluble (PWS) drugs, including small molecules and macromolecules such as peptides and proteins.
The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
The Leadership Summit will bring senior pharma executives together to discuss supply chain resilience, medicine security, and manufacturing capacity amid growing geopolitical fragmentation.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical industry and how CPHI Milan is addressing these areas this year.