Industry experts talk with PharmTech, Pharmaceutical Commerce, Applied Clinical Trials, and Pharmaceutical Executive about FDA's CNPV pilot program.

In Episode 30, John Androsavich, Benjamin Fryer, and John Wilkerson go behind the headlines.

The FDA Commissioner’s National Priority Voucher pilot program has added J&J’s Tecvayli as the latest voucher recipient.

Life sciences is a decade behind other industries in its optimization and strategic exploitation of data. This is perplexing, given how much companies profess their ambitions to exploit AI. An industry podcast brought together life sciences thought leaders to debate the subject. The panelists noted that really, by now, standardized data should be yielding greater intelligence, and powering pharma’s future, accelerated by AI. If only companies could find new momentum to finally sort out their underlying data. This article sets out some of the key points that arose from the panel.

FDA leadership initiated rapid drug review programs, enhanced transparency by publishing decision letters in real time, and strategically integrated AI into agency operations.

The approval was granted to USAntibiotics, with FDA saying it addresses pronounced antibiotic shortages in the past two decades.

Pharma R&D, formulation, and manufacturing are transforming via HPAPI advances, AI-driven automation, EU regulatory shifts, and patient-centric drug design.

The agency is approaching the new overhaul as a chance to reshape drug regulations in the European Union.

Co-legislators in Europe have reached a provisional agreement on a new pharmaceutical policy framework to help boost competitiveness, innovation, and supply chain security.

The collaboration will initially focus on advanced stages of solid cancers such as colorectal, pancreatic, lung, and breast, but may expand to other cancer types in the future.

The new Tethered Cap, which will be showcased at 2026 Pharmapack Europe, addresses the demand for sustainability with a TE safety ring that remains attached to the cap.

David Basile, VP Technical Operations, Americas, Hovione, explains what regulators expect for the maintenance of GMP facilities and equipment.

Luca Cavazzini, Sales & Marketing Director at IMA Active, discusses some of the industry’s most common manufacturing challenges, such as sustainability, continuous processes, and technology advancements.

In Episode 29, John Androsavich, Benjamin Fryer and John Wilkerson go behind the top headlines from 2025.

Technology advances are converging with cost and time pressures and formulation complexity to drive greater adoption of automated processes.

New drug delivery systems prioritize convenience and customization, using advanced technologies like nano-engineering and non-invasive routes to improve patient outcomes.

Increasing demand, complexity, and potency are driving innovation and investment in HPAPIs.

The articles in this issue reflect an industry in transition, committed to innovation while ensuring safe, reliable, and forward-looking pharmaceutical production.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, outlines the importance of batch recovery procedures in pharmaceutical manufacturing.

Counterfeit pharmaceuticals jeopardize public health worldwide, often leading to ineffective or dangerous treatments. Enter Raman spectroscopy: a rapid, non-destructive analytical technique that unveils the molecular secrets of medications. With its ability to identify counterfeit drugs through unique molecular fingerprints—even without unsealing their packaging—this technology is transforming pharmaceutical forensics and safeguarding global health.

Digital transformation, AI, 3D printing, and proactive maintenance are reshaping pharma, speeding discovery and demanding new manufacturing standards.

Biopharma quality control is being revolutionized by advanced analytics and digital transformation through a synergy that boosts quality and scalability.

Though not an actual creature, the aptly named longevity fund has announced a strategic investment in Etheros’ development of a new class of drugs.

Large-language models are excellent for general-use AI systems, but they don’t understand pharmaceutical companies’ proprietary documentation—the validated procedures and quality protocols that ensure drug safety. Smaller, domain-specific language models give companies more control and efficiency in their AI use.

FDA has granted orphan drug designation to FS2 (kynurenic acid) for the investigational treatment of idiopathic pulmonary fibrosis.

Starting with risk mitigation, GMP facility and equipment maintenance is all about anticipating problems before they happen and showing regulators a controlled environment.

The agency is expanding its use of artificial intelligence (AI) with the deployment of agentic AI for staff to create more complex AI workflows and harness AI models.

Live cell phenotypic screening can enhance translational predictability and speed up lead optimization.