Quality Systems

Cereno reports that its lead program, CS1, demonstrated encouraging efficacy while meeting its primary endpoint of safety and tolerability in a Phase IIa trial.

Continued process verification ensures pharmaceutical manufacturing stays in control through data analysis, trend detection, and lifecycle monitoring.

The authors propose a streamlined, efficient approach to determining specification equivalence that starts with a paper-based assessment of the methods and progresses to a data assessment for the methods under evaluation.

The treatment becomes the only approved twice-yearly option for pre-exposure prophylaxis for HIV prevention in the European Union.

The recall was in response to particulate matter found in the container.

The deadline for stakeholder consultation submissions on the new and updated regulations is Oct. 7, 2025.

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.

FDA’s recommendation to control 7-OH products under the Controlled Substances Act should help prevent competition between legitimate pharmaceutical medicines and those companies looking to circumvent FDA regulations, says Michael White, Distinguished Professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy and Chair of the Kratom Consumer Advisory Council.

The guidance document provides recommendations for identifying an optimized dosage for radiopharmaceutical therapies for cancer treatment during clinical development.

Based on an analysis done by the European Medicines Agency on the feasibility of alternatives, the European Commission maintains use of titanium dioxide in drug products.

Orphan status was granted based on Phase II data showing that treatment with rilzabrutinib reduced flares and improved markers while demonstrating consistent safety.

Florida’s emergency rule will classify certain concentration forms of 7-hydroxymitragynine opioid products as Schedule 1 controlled substances in Florida, a step FDA recommended for 7-OH opioids in July 2025.

The company’s expanded label for Avtozma (tocilizumab-anoh) now includes the treatment of cytokine release syndrome, aligning the therapy with all indications for which Actemra is approved in the US.

The agency’s new program is designed to increase regulatory predictability and streamline review of domestic manufacturing facilities.

Pharma manufacturing is headed toward smarter tools, deeper partnerships, and a renewed focus on compliance and quality at every stage of the product lifecycle.

A new nuclear magnetic resonance method reveals real-time, coordinated changes in nanoemulsion drugs, improving noninvasive analysis and regulatory evaluation.

The company’s FDA-approved first generic sertraline capsules secured a 180‑day exclusivity period, highlighting strategic generic development pathways.

The program has been transitioned to a permanent pathway that is designed to support innovative tools like artificial intelligence, wearables, and biomarkers in drug development and trials.

Help us get a better picture of how new tariffs and trade policy have impacted you and your organization.

The changes, required for safety labeling of all opioid drugs, will emphasize the risks with long-term use to combat misuse and addiction.

7-OH and the leaf of the kratom plant are not analogous, but as the former is a derivative of the latter, it has opioid-like qualities that make its susceptibility to abuse concerning.

FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and help prevent drug shortages.

The authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.

EMA is phasing out animal testing and is asking pharmaceutical companies to use new approach methodologies.

Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than limiting operator activities. Equipment, automation, procedural and component changes can be utilized to make the aseptic activities safer. This article offers suggestions for reducing the adverse impact of intervention throughout the aseptic process.

The agency has given a positive recommendation for a change in the gas propellant in Trixeo Aerosphere and Riltrava Aerosphere that will have a 1000-fold reduction in global warming potential compared to the current propellant.

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on supply security, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Artificial intelligence and machine learning can help identify complex patterns.

Sotyktu (deucravacitinib) has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.