Associate Editorial Director
How Pharma Can Build Resilient Supply Chains Amid Trade and Tariff Shifts
Cross-functional trade compliance planning is critical as pharma braces for broad 232 tariffs and shifting United States-China-India supply dynamics.
CMC and Analytical Gaps in CRLs: Why They Persist Despite FDA Guidance and How You Can Position Yourself for Success
Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and analytical issues despite early regulatory guidance. Review key risk points in analytical and tech transfer to better ensure commercial readiness.
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.
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.
Operators Are the Main Source of Contamination in Pharmaceutical Manufacturing
UK Anaphylaxis Nasal Spray Approval Helps Reshape Emergency Allergy Treatment
Newly approved needle-free adrenaline spray offers longer shelf life, better stability, and easier use, signaling a shift in emergency drug delivery design.
The 6-Stage Compounding Framework Every Pharmaceutical Manufacturing Professional Should Know
A structured, risk-based framework for pharmaceutical compounding that enhances quality, regulatory compliance, and process consistency.
FDA Approves Shingrix Prefilled Syringe to Simplify Vaccine Administration
AI Boosts Early Disease Detection and Diagnostic Accuracy
PODD 2025 Unveils Agenda Highlighting Innovation in Drug Delivery Technologies
The annual Boston conference will explore strategic partnering, device innovation, and delivery solutions for emerging therapeutics.
Why You Should Know About a New Weekly Injectable for Parkinson’s
Biodegradable weekly implant delivers stable levodopa levels, aiming to streamline Parkinson’s care while reshaping drug reformulation and delivery strategies.
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.
FDA Publishes More Than 200 Complete Response Letters
FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.
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.
Siemens Finalizes $5.1B Dotmatics Acquisition
Siemens expands AI-driven pharma software portfolio, integrating Dotmatics’ platform to connect drug research, development, and manufacturing digitally.
CureVac to Be Acquired by BioNTech in $1.25B Deal to Advance mRNA Cancer Therapies
The acquisition boosts BioNTech’s mRNA design and manufacturing capabilities, accelerating development of next-gen cancer immunotherapies.
Elkedonia Raises €11.25M Seed Round to Advance Neuroplastogen Therapy for Depression
Elkedonia will develop first-in-class Elk1 inhibitors for treatment-resistant depression, targeting neuroplasticity without psychedelic side effects.
Implications of RFK Jr.’s CDC Vaccine Committee Overhaul for the Pharmaceutical Industry
The dismissal of all 17 members of the Advisory Committee on Immunization Practices has far-reaching impacts for the industry and beyond.
pharma& Secures MHRA Approval for Pegasys API Production at Loba Biotech
MHRA approves Loba Biotech to manufacture Pegasys API, enabling pharma& to strengthen UK supply and ensure continued access for eligible patients.
Sanofi to Acquire Vigil Neuroscience to Expand Neurodegenerative Disease Pipeline
Sanofi is acquiring Vigil Neuroscience, a biotech firm focused on novel neurodegenerative disease therapies, to boost its early-stage neurology pipeline.
Emerson Unveils AI Platform for Mission-Critical Industrial Applications
Emerson’s purpose-built industrial AI solutions are meant to enhance accessibility and reliability, enabling manufacturers to maximize efficiency and performance from automation systems.
FDA Refines Regulatory Pathway for Canadian Drug Importation
FDA announced efforts to streamline its drug importation process to help U.S. states and Native American tribes access lower-cost Canadian drugs while maintaining safety standards.
Mirai Bio and Thermo Fisher Partner to Advance Genetic Medicine Manufacturing
Mirai Bio and Thermo Fisher partner to integrate AI-driven design with CGMP manufacturing, aiming to streamline development of genetic medicines.
IND Application Cleared for Phase II Trial of Grifols’ Dry Eye Disease Drops
Grifols received FDA clearance to begin a Phase II trial of GRF312, an immunoglobulin eye drop for dry eye disease, aiming to improve current treatments.
Personalised Capsule Machine Unveiled by ACG
ACG partnered with Art of You to launch the world-first Personalised Capsule Machine, enabling on-demand, customized supplement capsules based on individual health data.