Duloxetine was recalled over excess nitrosamine impurity, renewing scrutiny of process controls across generic drug manufacturing.

Karianne Gelinas, LVEDC, outlines workforce strategies to fill 850 technical roles ahead of Eli Lilly's major Lehigh Valley manufacturing investment.

Attention around pharmacovigilance transformation potential has tended to focus on automating discrete steps in the case-processing pipeline. End-to-end ICSR autonomy may enable near-instantaneous case processing so that current SUSAR targets become obsolete.

A warning letter, a hard look at why “a human reviews it” doesn’t settle anything, and one company’s argument that accuracy was never the real problem.

Kristin Ciriello Pothier, KPMG US, discusses biopharma dealmaking shifting toward strategic precision, with oncology, GLP-1s, and manufacturing complexity reshaping M&A valuations in 2026.

The FDA priority review granting of AstraZeneca’s ravulizumab reinforces the commercial and scientific rationale for sustained investment in complement biology platforms.

As quality control labs move toward more connected, data-driven operations, digital technologies must be adopted in a way that upholds patient safety.

Lehigh Valley's deep manufacturing base, community college partnerships, and apprenticeship programs positioned the region to attract Eli Lilly's investment.

Treatment pipelines for rare diseases have never been more promising. Optimizing their impact will require integrated, precision-first CDMO support systems.

CAI's Jon Thompson details how digital twins cut cleanroom commissioning time by up to 30% and accelerate GMP deviation investigations.

GSK's momelotinib receives US and EU orphan drug designations for VEXAS syndrome, a rare myeloid disorder with 30–40% five-year mortality and no approved treatments.

Tom Sellig, Adare, discusses 3D-printed tablets, US reshoring investment, FDA timeline pressures, and workforce development strategies driving CDMO growth.

GLP-1 / insulin demand is straining CDMO fill-finish capacity. This piece examines bottlenecks in automated pen injector assembly and strategies to optimize operations.

The EMA’s annual report shows the agency approved 104 human drugs in 2025 that included first-in-class and first-in-indication therapies.

Molly Klote, Klote Medical Research Advisors, discusses how pharma must move beyond tariff-driven reactions to build evidence-based, quality-led supply chain resilience that satisfies FDA scrutiny and protects patient access.

GSK boosts oncology pipeline with Nuvalent acquisition, advancing FDA-designated ROS1/ALK inhibitors for NSCLC and expanding kinase inhibitor drug development in lung cancer.

Nicholas Richardson, vice president of clinical development at Precision for Medicine, explains why radiopharmaceuticals are unique for patients with cancer and what makes them challenging to develop for those patients.

The standards organization’s annual drug shortages report finds drug shortages lasting longer and the number of discontinuations rising, but the number of shortages themselves have gone down.

Pharmaceutical suppliers face growing pressure to calculate product carbon footprints as customer requirements and global regulations tighten.

Three primary clinical data management architectures--Clinical Data Warehouses, Clinical Data Lakes, and Clinical Data Lakehouses--are the newest technologies aiming to leverage AI for predictive analytics.

J&J and Roche commit billions to protein degrader platforms, signaling a new era in oncology drug development with major manufacturing implications.

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies can investigate patient complaints involving prefilled syringes and combination products.

Regulatory reform, patient access, and supply chain security were 3 of the key themes showcased this week on PharmTech.com.

Tom Sellig, Adare Pharma Solutions, shares how the CDMO is positioning for growth amid US reshoring and oral dose innovation trends.

At CPHI Americas, Molly Klote, Klote Medical Research Advisors, spoke about how the pharma industry faces tariff volatility and reshoring pressure. She warned FDA wants actionable supply chain plans, not slogans, with quality built in.

The established safety profiles, dosing regimens, and manufacturing pathways of repurposed generics can significantly shorten timelines and reduce costs as alternative cancer therapies.

At CPHI Americas, Delaware Gov. Matt Meyer argues domestic pharma manufacturing is a national security priority and positions Delaware as the ideal reshoring hub.

Changes in regulations are reducing costs, expediting approval, and increasing the market for biosimilars.