
In this week’s news, industry shifts are marked by new FDA draft guidances, Pfizer’s agreement to MFN pricing, Novartis’ launch of DTP distribution, and AI-driven protein design.
In this week’s news, industry shifts are marked by new FDA draft guidances, Pfizer’s agreement to MFN pricing, Novartis’ launch of DTP distribution, and AI-driven protein design.
Pfizer re-balances weight loss portfolio with Metsera, Bristol Myers Squibb and Roche make breast cancer progress, and Keytruda gets under your skin.
This week’s roundup highlights US manufacturing localization via tariffs, Pfizer’s $4.9 billion deal, and new tech in CRISPR, RNA, and continuous processing.
In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, PhD, Parexel, answer questions on the use of real-world evidence for both small-molecule and large-molecule drug development. In addition, they tackle a question on supply chain security problems that arise during transportation of pharmaceutical goods.
Regulatory crackdowns on risk disclosure rise, policy instability affects public health, and drug innovation focuses on advanced therapies and AI-driven discovery.
SynaptixBio CEO Dan Williams discusses how small biotechs drive rare disease innovation with genetic research, partnerships, and patient advocacy in a third interview installment.
FDA transparency, AI in manufacturing, automation for quality, and cell/gene therapy advancements are driving the biopharma industry forward.
SynaptixBio CEO Dan Williams notes how rare-disease drug development is advancing on the back of FDA incentives, priority review vouchers, and a growing recognition of unmet needs.
Benjamin McLeod and Sebastian Lykke Skafte Andersen go behind the headlines to examine the motivations behind recent M&A activity, tariff responses, and more.
Dan Williams, PhD, SynaptixBio CEO, discusses how rare disease drug development leverages genetic targeting and drives innovation and investment in pharmaceutical technology and precision medicine.
Jonathan D. Grinstein, PhD, Manfred Scholz, PhD, and Erik Wiklund, PhD, go behind the headlines to address a shifting policy landscape and what it means for the future of chronic disease, diagnostics, and next-generation cell and gene therapies.
US pharma firms face higher drug costs, delayed launches, and compliance risks from proposed sectoral tariffs, prompting urgent supply chain reviews.
In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss if and when identity testing is necessary to be performed on a final product when the API is sourced from a third party.
US pharma tariffs may start low and rise, risking drug shortages, higher costs, and pressure on generics amid reshoring push.
BioPharm International® spoke with Robert Cornog, senior director, Product Development, at Quotient Sciences about how commercial manufacturing and tech transfer impact biopharmaceuticals at the development stage.
BioPharm International® spoke with William O. Bullock, Senior VP, Economic and Statewide Development, North Carolina Biotechnology Center, about the growing biotechnology industry in North Carolina.
BioPharm International® spoke with Jon Ellis, CEO, Trenchant BioSystems, about the commercial landscape for cell therapies and how digitization is impacting the industry.
BioPharm International® spoke with Oury Chetboun, CEO of Seekyo Therapeutics, to get his perspective on what impact new modalities and technology innovations are having on biopharmaceutical development.
In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how to address an FDA warning letter citation for a failure to establish a quality control unit.
BioPharm International® spoke with Ryan Larson, PhD, SVP, Head of Research at Umoja BioPharma about how emerging modalities in cancer treatments, including cell therapies, are evolving.
BioPharm International® sat down with Noah Kopcho, field application scientist at Gyros Protein Technologies, to talk about the challenges in the production of AAV vectors.
BioPharm International® spoke with Lun Xin, associate director at WuXi Biologics, about how automation can accelerate and improve the formulation of high-concentration biologics.
BioPharm International® spoke with Lun Xin, associate director at WuXi Biologics, about high-concentration biologics and some of the biggest challenges associated with their formulation.
In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss EMA’s revised guidelines on data protection in marketing authorization applications.
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.
Andrew Moreo, head of Process Development and Pre-clinical Manufacturing at Andelyn Biosciences, talks with BioPharm International® about the benefits and challenges of gene therapies developed to treat cancer.
Christine Mya-San, global account manager at Roquette Pharma Solutions, discusses the most significant pharma ingredients at play over the past year and looks ahead at ingredient innovation.
Russell Miller, vice-president of Global Sales & Marketing at Enzene, discusses how continuous bioprocessing is at the forefront of changing biologics manufacturing moving forward.
PharmTech Group sat down with Anil Kane of Thermo Fisher Scientific live on site at DCAT Week 2025, to talk about technologies and digital solutions companies are using to meet demand across the bio/pharma industry.