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On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.

Vitrakvi (larotrectinib) was first granted accelerated approval by FDA in November 2018.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the use of artificial intelligence and machine learning in pharmaceutical development and manufacturing.

Development of the state-of-the-art facility was made possible by a £2 million (US$2.6 million) round of funding, and a successful inspection by MHRA was completed in March 2025.

The company has plans to invest $23 billion during the next five years to expand manufacturing and R&D in the US, which will include seven new facilities.

Even with, or perhaps because of, the rapidity with which changes in United States policy are developing, many in the bio/pharmaceutical industry are taking a longer view.

Pharmaceutical Technology® Group spoke with Erik Wiklund, CEO of Circio, about the impact of the post-COVID-19 world on the pharmaceutical industry and how that has shifted the talent pool.

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about the bio/pharmaceutical trends from 2024 that continue to impact the industry in 2025.

Siemens said spending on AI software is predicted to double by the end of the 2020s, in a market increasingly driven by structural shifts that underscore a need for digital transformation.

SkyCell is working with Microsoft to incorporate SkyCell’s AI-powered supply chain solution into Microsoft Teams and Copilot.

Lack of skills in the AI realm was a distant second among those surveyed about the biggest barrier to innovation while using the technology.

Joe Bobacher of OPW Engineered Systems spoke with Pharmaceutical Technology® Group at INTERPHEX 2025 about fluid transfer in controlled environments and the importance of guarding against product loss.

As single use becomes more prevalent, end users are looking for more customization, and regulators are refining their rules, says Todd Andrews of CPC in an interview with Pharmaceutical Technology® Group.

Advanced solutions are improving drug dissolution, absorption, and overall therapeutic performance.

Dean Bornilla, Pace® Life Sciences, highlights his organization's future role in supporting biopharmaceutical development and manufacturing coast-to-coast.

3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

Michael Franco, global sales director at PSG Biotech, spoke with the PharmTech Group at INTERPHEX 2025 about recent advancements in pharmaceutical flow sensor technology.

Bringing in external expertise may be necessary when internal knowledge is lacking, but it is critical that any contract employee or consultant is comprehensively assessed to ensure the right person is employed.

Pharmaceutical Technology® spoke with Krishna Kanumuri, CEO of Sai Life Sciences, about which trends from 2024 will carry over and impact the bio/pharma industry in 2025.

In part two of Pharmaceutical Technology® Group's discussion with Joe Katakowski, director of Research at the RTW Foundation, the work of organizations like RTW Foundation in promoting the development of treatments for ultra-rare diseases is discussed.

The yearly convention in New York City showcased new and emerging technologies and gave participating exhibitors a chance to unveil their strategies for the second half of the 2020s.

Josh Hoerner, general manager of Purisys, provides his perspective on FDA’s recommendations for acceptable intake limits for N-nitrosamine impurities.

The Pharmaceutical Technology® Group sat down with Joe Katakowski, director of Research at the RTW Foundation about the challenges involved in the development of treatments for ultra-rare diseases.

The move towards “pharma 4.0” requires a major shift, both ideologically and technologically, to adapt current processes to a framework that will automate much of today’s manufacturing.

Sitting down with the PharmTech Group at INTERPHEX 2025, Nicole Hunter, head of Global WMArchitect at WMFTS, explains the industry initiative around single-use assembly components resulting from supply disruptions caused by the COVID-19 pandemic.

The Pharmaceutical Technology® Group sat down with Chris Gooding, general manager at CRL Solutions, to learn more about how beta bags assist in the transfer of supplies and equipment into a sterile environment.

Speaking with the PharmTech Group at INTERPHEX 2025, Dave Loula, global product director, ITT Engineered Valves, discusses innovation in advanced sensing technologies that addresses customer need for reliable valve function.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.

The Act is the European Union’s plan to avert drug shortages.