Drug Development

Novo Nordisk’s Wegovy will be competing with Madrigal Pharmaceuticals’ Rezdiffra in the metabolic dysfunction-associated steatohepatitis arena.

The 2024 edition of the annual conference, held in Milan, attracted more than 59,000 professionals from across the bio/pharmaceutical landscape.

The two organizations are collaborating on an integrated translational biology platform for the development of radiopharmaceuticals.

Scientific discovery, technological evolution, and market demands are constantly reshaping the landscape.

Aaron Cowley, Recipharm Advanced Bio; Renee Hart, LumaCyte; and Vibha Jawa, EpiVax, go behind the headlines to delve deeper into recent market deals driven by Big Pharma patent cliffs and the complex manufacturing of ATMPs.

Bothe data integrity and quality of data are critical for drug discovery, manufacturing efficiency, regulatory compliance, and patient safety.

The partnership, which has received £118 million (US$158 million) in research funding, aims to establish a better understanding not only of how the body fights infection, but also how vaccines protect it.

This article previews some formulation topics discussed in the Pharma Fundamentals series, which aims to enhance learning for professionals in pharmaceutical drug development and manufacturing.

Aficamten is a small-molecule cardiac myosin inhibitor that was compared for the first time in the trial to the standard-of-care beta blocker.

EMA and WHO have collaborated for a decade, with WHO utilizing EMA’s scientific expertise to fulfill its mandate to improve access to safe and effective medicines.

AC-201 is being developed in a novel, oral formulation as a potent inhibitor that binds to the pseudo kinase domain, JH2, of TYK2/JAK1.

This article investigates the role of flavoring agents and taste modulation strategies and describes how these solutions can help to mask unpleasant tastes, improve palatability, and, ultimately, increase patient compliance to drive better treatment outcomes.

Dan Williams, CEO of SynaptixBio discusses drivers of rare disease drug development, including FDA incentives, priority review vouchers, and a growing recognition of unmet needs.

This comprehensive overview of contemporary formulation strategies covers the drug product lifecycle from end to end, illustrating best practices for various formulation types seen through a CRDMO’s lens while also covering problem solving, the role of digital tools, and geopolitical changes.

The company will be adding a 160,000-square-foot dedicated manufacturing facility at the FUJIFILM site in Holly Springs, NC.

Orlynvah is the first new, branded product for the treatment of uncomplicated UTIs to be introduced in the US in more than 25 years.

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.

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 is not developing an mRNA vaccine, but had been using one as the control in a 10,000-subject Phase IIb trial.

The new targeted pipeline will advance Nxera’s oral GLP-1 agonists, novel GPCR targets, and structure-based drug design to address obesity and related health conditions.

New manufacturing methods are being explored, but challenges are still present in personalized medicine development.

For the first target addressed in the partnership, the two companies reported the successful delivery of AI-designed, functional antibody leads.