New legislation will improve patient access to innovative medicines in Europe and the United Kingdom.

In this episode of Ask the Expert, Susan J. Schniepp and Siegfried Schmitt discuss how companies should approach preventing product recalls.

Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about the technologies being used to fight counterfeiting and how predictive modeling can be used to validate transport conditions.

Merck acquires Terns Pharmaceuticals for $6.7B, gaining TERN-701, a promising oral CML therapy with a novel mechanism and early Phase I/II clinical data.

Quality control for pharmaceuticals is evolving with the assistance of digital tools, sustainability practices, and a push to move manufacturing onshore.

In regard to their presentations at PDA Week 2026, Richard Jaenisch and David Jaenisch discuss balancing AI integration with human expertise, compliance, and IP protection.

Olon is expanding global biologics and high-potency manufacturing capacity across four countries, with major ADC chain investments completing in 2026.

Hybrid cloud architecture enables pharma organizations to balance public cloud scalability with private infrastructure control, accelerating drug development while maintaining regulatory compliance.

Tony Lakavage, executive vice president and head of Global External Affairs, US Pharmacopeia (USP), discusses how IRA negotiations, Most Favored Nation pricing, US manufacturing push, and new FDA biosimilar guidance are reshaping the industry.

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology advocates clinically relevant PDX models to bridge preclinical and clinical gaps for radiopharmaceutical success.

Pharma companies reveal capacity expansions and strategic pivots at DCAT Week 2026, signaling where supply chain investment is heading.

The FDA approved higher-dose semaglutide (7.2 mg) in 54 days under its new priority voucher program, signaling faster reviews for drug developers.

FDA’s 2024-2025 guidances and policy signals, when read together, point to a digital-by-default oversight model built on structured data exchange, more routine remote engagement, and clearer expectations for lifecycle control of automated systems used in regulated decisions. This article translates those signals into practical steps for chemistry, manufacturing, and control, as well as quality management systems.

FDA's March 2026 draft guidance outlines a validation framework for non-animal drug testing methods, signaling a shift in nonclinical submission expectations.

A framework for 2026 that moves beyond manual AI onboarding toward "zero-lag" integration for pharmaceutical manufacturing.

European biotech companies are exploring new therapeutic targets on T-cells to overcome drug resistance and improve clinical outcomes in cancer.

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology explains how patient-derived xenografts improve drug biodistribution studies and first-in-human dose accuracy.

The FDA approves icotrokinra, the first targeted oral peptide blocking the IL-23 receptor, for moderate-to-severe plaque psoriasis with Phase III data across 2,500 patients.

Industry experts explain how incorporating sustainability into the early development phase creates greener pharmaceutical manufacturing.

SGD Pharma and Prince launch sterile Type I glass nasal vials for the US market, targeting complex chronic conditions like Alzheimer's and Parkinson's.

The new €3.2M (US$3.7M) research lab will investigate immunogenic cell death mechanisms in lung cancer to improve how existing therapies trigger immune response.

The FDA will evaluate tildrakizumab-asmn for psoriatic arthritis. A 2026 decision is expected based on Phase III clinical trial data.

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology, discusses PDX models preserving tumor architecture and heterogeneity, yielding clinically relevant data for more accurate radiopharmaceutical translation.

This week, the industry experienced accelerated digital transformation, regulatory evolution, and a strategic shift toward complex, patient-centric modalities.

Rare disease drugs are forecast to exceed $400B by 2032, driven by policy shifts and pipeline growth, despite competition from large-indication products.

groninger will present innovations in equipment lifecycle programs, RTU platform flexibility, and earlier format alignment at INTERPHEX NYC, 2026.

FDA replaces seven fragmented adverse event databases with AEMS, enabling real-time safety signal access for pharmaceutical manufacturers and researchers.

Japan's largest pharma event returns May 2026 with 320 sessions spanning manufacturing, quality, CMC, and digital transformation.