Christopher Cole is Associate Editorial Director for BioPharm International®, Pharmaceutical Technology®, and Pharmaceutical Technology Europe™.
Your Voice in Biopharma's Digital Shift: Manufacturing & Tech Adoption Survey
At a critical turning point in the adoption of digital tools across the bio/pharma industry, we want to hear to industry professionals on where things actually stand.
Survey Insights: How Tariffs and Trade Policy Impact Bio/Pharma
This video clips offers topline findings from our survey of nearly 90 bio/pharma professionals on the impacts of Trump-era tariffs and trade policy.
Novo Receives FDA 483 for Acquired Catalent Site
FDA cites Indiana drug plant for contamination, pest issues, and unresolved equipment failures, raising concerns over pharma manufacturing quality.
How the 15% US-EU Tariff Cap Affects Bio/pharma
The US-EU pharma tariff cap has been finalized at 15%, impacting manufacturing, supply chain, and quality and promoting domestic production and resilience.
Bio/Pharma's Response to Tariff and Trade Policy: Survey Results
Survey responses indicate that bio/pharma faces tariff-driven rising costs and supply strain, with firms aiming to boost compliance and diversification and seeking stable trade and R&D support.
Intellectual Property as a Core Strategy in Drug Formulation and Development
Dave Miller, PhD, explains how early formulation planning, novel platforms, and tailored approaches secure long-term protection against generics.
Sustainability Becomes Essential: Green Manufacturing and Supply Chain Resilience in Bio/Pharma
Dave Miller, PhD, explains how environmental audits, waste reduction, and supply chain security are reshaping priorities in pharmaceutical manufacturing.
Onshoring’s Unexpected Benefits: Quality, Efficiency, and Supply Chain Resilience
Dave Miller, PhD, discusses how shifting drug manufacturing to domestic CDMOs can improve quality, reduce rework, and enhance long-term efficiency.
Biopharma Development Hurdles: Lessons from Vedanta’s Live Bacteria Cocktail Failure
The Phase 2 trial failure highlights the need for Biopharma to optimize R&D, ensure manufacturing resilience, and adapt to evolving regulations.
The Importance for CDMOs of Partnering With a Sponsor’s Mindset
Dave Miller, PhD, explains how a development-first approach, scientific depth, and regulatory trust build lasting partnerships in the CDMO space.
Collaborative Innovation in CDMOs: Dave Miller, PhD, on Early Engagement, IP Strategy, and Advanced Formulation
Dave Miller, PhD, discusses how tailored solutions, trust, and lifecycle planning are redefining partnerships in bio/pharmaceutical development.
Prasad Returns to Head FDA’s CBER
FDA reinstates Vinay Prasad to lead CBER as gene therapy safety concerns spotlight regulatory challenges in biotech manufacturing.
Survey: Impacts of Tariffs & Trade Policy on the Bio/pharmaceutical Industry
Help us get a better picture of how new tariffs and trade policy have impacted you and your organization.
PL BioScience Expands Cell Culture Manufacturing Capacity to Meet Global HPL Demand
Germany-based biotech boosts animal-free supplement production, enabling greater scalability and supply security for next-gen cell therapies worldwide.
FDA Shake-Up: Vinay Prasad Exits Amid Tumult in Biologics Oversight
Prasad’s short FDA tenure brought stricter review standards for gene and COVID vaccines, sparking biotech concern and political backlash.
AstraZeneca’s Imfinzi Advances in Gastric Cancer With FDA Priority Review
Imfinzi’s application is supported by Phase III trial data showing improved pathologic complete response in early-stage gastric cancer.
Trade Policy Shifts: Compliance and Cost Strategies for Pharma
US pharma firms face higher drug costs, delayed launches, and compliance risks from proposed sectoral tariffs, prompting urgent supply chain reviews.
Manufacturing and CMC Challenges in Immunotherapy: Lessons from Recent Complete Response Letters
FDA’s recent CRLs for Replimune’s RP1 and others spotlight growing scrutiny on manufacturing, analytical rigor, and tech transfer in immunotherapy development.
Tariffs & Trade Policy: What to Watch for, Cost Impacts, and Supply Chain Strategies
US pharma tariffs may start low and rise, risking drug shortages, higher costs, and pressure on generics amid reshoring push.
What Pharma Manufacturers Need to Know About US Trade Policy Changes
Tariffs on APIs and finished drugs could take effect as early as August 1, with accelerated investigations raising urgency for supply chain planning.
7 Expert Strategies to Control Contamination in Cell & Gene Therapy Manufacturing
Minimize contamination in cell therapy manufacturing with isolators, staff protocols, sterile materials, and validated suppliers for process integrity.
What Sarepta’s Layoffs, and Others Across Biopharma, Mean for Industry Professionals
Biopharma job cuts surge in 2025, hitting R&D, manufacturing, and commercial roles and causing professionals to face shifting priorities and tighter pipelines.
FDA Approves Shingrix Prefilled Syringe to Simplify Vaccine Administration
How tRNAs Could Revolutionize Treatment for Dravet & More
LEO Pharma Takes Over Global Development of Spevigo for Rare Skin Disease GPP
The IL-36 inhibitor is being explored for additional inflammatory skin conditions, aiming to expand treatment options for underserved patient groups.
Junevity's Bold Move: Using siRNA to Fight Diabetes and Obesity
9 Implications of Trump’s Tax-Cut and Spending Bill for the Bio/Pharmaceutical Industry
Trump’s tax bill could reshape drug R&D, manufacturing, Medicaid access, clinical trials, and biotech funding, impacting strategy across the bio/pharmaceutical industry.
5 Ways mRNA Is Revolutionizing Drug Development Beyond Vaccines
Once limited to experimental vaccine platforms, messenger RNA (mRNA) is now taking center stage across the entire biotech landscape.
Biopharm Industry Impacts of FDA Eliminating REMS for CAR-T Therapies
Regulatory shift reflects maturation of CAR-T field and impacts biopharm manufacturing, development, and discovery.
SynaptixBio Responds to UK’s £650M Genomics Initiative with Call for Implementation Clarity
The biotech company urges government action to support newborn genome screening, emphasizing the need for rare disease care, testing, and family resources.