Samantha Hadfield, PPD, explains how mixed FSP/FSO models help sponsors balance speed, cost, and complexity in clinical trial outsourcing.

The collaboration will use Andelyn’s viral vector process to produce clinical-grade material for an upcoming gene therapy trial.

LEO Pharma acquires dersimelagon from Tanabe Pharma for up to $435M, adding a late-stage oral rare dermatology asset under FDA review.

This episode of PharmTech Explained discusses how China's biotech surge is reshaping US drug licensing, manufacturing control, and FDA data trust, the key shifts pharma professionals must track.

A dual-delivery capsule platform delivers multiple APIs in a single dosage unit, reducing pill burden and simplifying dosing regimens.

Glenn Herring, Halo Pharma, discusses its new sterile fill-finish platform: Groninger/SKAN tech, GMP design, and 2026 qualification timeline.

In part 2 of this 2-part interview, Silvia Forroova, director of Partnerships & Sustainability at CPHI, and founder of the CPHI Sustainability Collective, tells PharmTech about the challenges in achieving sustainability in pharma and how the CPHI Sustainability Summit, which launches at CPHI Milan 2026, can help organizations tackle these challenges.

This week, a $2.3 billion manufacturing campus and a new fill-finish platform signal capacity is crucial; AI in pharma is still evolving; and CPHI Milan previews a new Sustainability Summit.

FDA approves TAUKLARIFY, a tau PET imaging agent for Alzheimer's, adding a biomarker tool that could shape trial design for drug developers.

EMA’s draft GMP Annex 22 sidelines LLMs in critical manufacturing, fueling a push for risk-based guardrails and human accountability.

PharmTech spoke with Silvia Forroova, director of Partnerships & Sustainability at CPHI, and founder of the CPHI Sustainability Collective, about the new Sustainability Summit that will launch at CPHI Milan 2026 and how it can help organizations obtain measurable, commercially viable solutions for sustainability in the pharma industry.

Pen injector pre-assembly demands 160 PPM precision: LVDT/vision systems, tolerance control, and GAMP5 challenge testing ensure ISO 11608 compliance.

Richard Jaenisch, Open Biopharma breaks down AI's real limits in drug discovery, agent security risks, and what workforce readiness looks like by 2028.

Sentynl and Mereo's alvelestat deal for AATD-LD signals early manufacturing collaboration ahead of phase 3, shifting care from IV to oral therapy.

Glenn Herring, Halo Pharma, details the CDMO's new sterile fill-finish platform, Groninger/SKAN tech, GMP/Annex 1 design, and 2026 qualification timeline.

This year’s conference agenda includes more than 260 industry experts, a new Sustainability Summit, and zones targeting AI, cold chain, and labeling.

Lee Karras CEO, Halo Pharma ties the move to US injectable capacity along with an introduction to Halo’s new sterile fill-finish platform before GMP qualification.

Pharma's AI ROI gap isn't strategy or tech; it's the missing workforce qualification step every other regulated capability requires.

BMS's Investing $2.3B into its Houston campus signals a shift toward flexible, multi-modal manufacturing.

Venture-based Danish biotechs are driving innovation and gaining traction with investors.

This week’s content included Moderna's mRNA flu approval, CMO governance tips, OSTP’s deregulation push, a $2 billion oncology license, and July's regulatory wrap-up.

A phased playbook for moving life sciences data warehouses to a compliant, AI-ready cloud Lakehouse, balancing GxP rigor with faster insights.

The genetically modified oncolytic viral therapy, used in combination with nivolumab, was approved by the agency after data showed 1 in 4 patients responded to treatment.

In this episode, we discuss AI drug discovery hype, agent security risks, and why pharma's AI workforce bets remain unproven.

The FDA approved the first orexin receptor agonist for narcolepsy type 1, which validates a new mechanism-driven approach shaping CNS drug development and regulatory pathways.

FDA approves Moderna's mFlusiva, the first mRNA flu vaccine, testing the platform's manufacturing case amid federal funding cuts.

PharmTech spoke with Dr. Hui-Yin (Harry) Li, president and CEO of Wilmington PharmaTech, about steps that should be taken to build a productive relationship between sponsor and contract organizations.

OSTP's July 2026 report to Trump diagnoses U.S. science slowdown and pushes deregulation, new funding models, reshoring, and AI-driven "Genesis Mission."