title: Antibiotics: the changing regulatory and pharmaceutical industry paradigm.
abstract: Drug licensing is changing. Previously, regulators prioritized the licensing of innovative drugs that fulfilled a high unmet medical need for a small number of patients, including orphan, cancer and HIV medicines. Alternatives to large and costly prospective, randomized, double-blind clinical trials have led to a more bespoke development, such as adaptive design studies. Regulators have recently agreed to include much-needed narrow-spectrum antibiotics, active against certain MDR bacteria, in this paradigm. The background to why big pharmaceutical companies have largely deserted the antibacterial research arena, and the proposals that are hoped to reinvigorate their interest, are presented.
authors: TranScrip Partners LLP, 400 Thames Valley Park, Reading, Berkshire RG6 1PT, UK Institute of Pharmaceutical Science, King's College, London, UK richard.bax@transcrip-partners.com.
authors: Richard
authors: R
authors: Bax
authors: TranScrip Partners LLP, 400 Thames Valley Park, Reading, Berkshire RG6 1PT, UK.
authors: Samantha
authors: S
authors: Green
mesh_terms: D000900:Anti-Bacterial Agents / Q000191:economics* / Q000302:isolation & purification*; D017277:Drug Approval / Q000191:economics* / Q000379:methods*; D055808:Drug Discovery / Q000191:economics* / Q000379:methods*; D004345:Drug Industry / Q000639:trends*; D006801:Humans
chemical_list: D000900:Anti-Bacterial Agents
keywords: adaptive design; antibacterial use; antibiotic pricing; antimicrobial resistance; narrow spectrum antibiotics; regulatory approval