PharmTech Weekly News Roundup — Week of November 24, 2025

In this PharmTech video feature, we highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week.

Collectively, the week’s coverage discusses the pharmaceutical industry’s recent developments and current regulatory landscape. Read on for recaps of each story we’ve covered.

Key AI applications in drug development?

Artificial intelligence (AI) and machine learning tools are now driving transformative shifts across bioanalysis, preclinical testing, and formulation optimization throughout the industry. In drug discovery, advanced models predict optimal solubilization technologies for poorly soluble candidates and characterize drug–excipient interactions, which systematically reduces reliance on empirical trial-and-error and minimizes API consumption. Digital twins, trained on large-scale, multi-modal data, are also enhancing preclinical evaluation by accurately forecasting organ function and enabling paired statistical analysis, which can accelerate drug discovery by reducing study size.

What are the regulatory/risk implications of compressed review timelines?

The FDA Commissioner’s National Priority Voucher (CNPV) pilot program offers the unprecedented opportunity to reduce drug application review times from 10–12 months to just one or two, particularly benefiting generics and biosimilars. This acceleration requires sponsors to conduct market access, manufacturing, and post-approval readiness activities in parallel, starting early in development, as there is no time to fix compliance gaps once a file is submitted. Therefore, compressed timelines amplify every weakness in a company’s quality risk management framework, demanding proactive inspection preparation and early investment in chemistry, manufacturing, and controls strength.

Where is the onshoring benefit?

Onshoring is an explicit selection criterion for the CNPV program, which FDA uses to steer advanced manufacturing, especially sterile injectables and biologics, back to the United States to strengthen supply chain resilience. This provides generic and biosimilar sponsors with numerous opportunities for significant pre-submission communication with FDA—a rare luxury for sponsors of non-complex generics—with the expectation that most issues are resolved before the dossier is formally filed. The program aims to safeguard critical manufacturing know-how, encourage modernization using continuous manufacturing, and enhance regulatory agility by leveraging US-based facilities that are easier to inspect.

What is FDA planning for epinephrine access?

FDA, in conjunction with Duke University, is convening a public workshop to jump-start the discussion about expanding accessibility and use of epinephrine to reduce morbidity and mortality related to anaphylaxis. This focus follows the recent global approval of Neffy, a nasal spray formulation of epinephrine developed by ARS Pharmaceuticals, which provides a needle-free alternative to traditional auto-injector devices. This innovation addresses the clinical challenge that patients, particularly young people, may be reluctant to carry or correctly use auto-injector devices due to fear or stigma.