Quality Systems

In part 2 of his overview on hold times in biopharmaceuticals, Robert Dream details the regulations that govern hold times and how to mitigate risks that can occur during hold times.

Agentic AI changes the question from what a model can produce to what a system is allowed to decide.

FDA approves Rasonque (daraxonrasib), the first broad RAS-targeted therapy for metastatic pancreatic cancer, validating RAS(ON) inhibition for future drug development.

FDA priority review of Jemperli for biomarker-defined rectal cancer signals capacity, supply chain, and global filing shifts for manufacturers.

REGENXBIO's RGX-121 faces an FDA clinical hold after asymptomatic spine MRI findings, highlighting long-term imaging surveillance for CNS gene therapies.

The FDA grants accelerated approval to Ultragenyx's Genglycos, the first gene therapy for GSDIa, raising manufacturing and post-market monitoring questions.

The FDA approves first therapy shown to reduce new bone lesions and flare-ups in fibrodysplasia ossificans progressiva (FOP), based on a 63-patient trial using CT-scan efficacy endpoints.

In this episode of Ask the Expert, Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopeias.

The Trump administration nominates Heidi Overton for FDA commissioner amid leadership instability, raising questions for drug developers on review timelines and oversight.

FDA grants Priority Review to Teva's ecopipam new drug application, backed by phase 3 data. Ecopipam is a first-in-class D1 receptor therapy for pediatric Tourette syndrome.

Postmarketing governance must be evidenced across the full life cycle—design, validation, and live monitoring—not documented once and assumed to hold.

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.

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

Lee Karras, CEO, Halo discusses the company's new sterile fill-finish platform, Apotex partnership, and injectable onshoring strategy.

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

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

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.

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.

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.

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.

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.

Pharma's 2026 predictions revisited: AI tools have arrived, but organizational readiness, data governance, and regulatory gaps now limit real-world impact.

Modernizing infrastructures, record drug approvals, and harmonization were all positive regulatory advancements in July 2026.