Drug Development

Siegfried Schmitt, PhD, vice-president, Technical at Parexel, answers questions on the use and benefits of real-world evidence for small-molecule and large-molecule drug development.

This article takes a look at the developing use of AI in pharmaceutical development and manufacturing.

The go-ahead for Novartis’ oral treatment marks a new option for patients with spontaneous urticaria who remain symptomatic despite antihistamine therapy.

Sept. 30 marked 61 days since July 31, one day past the timeframe President Donald Trump had set forth for companies to lower prescription drug prices in the United States.

A draft reflection paper on patient experience data is up for public consultation until Jan. 31, 2026.

Vienna to host BIO-Europe 2025, connecting top biopharma companies for collaborations and pipeline development.

The dispute shines a light on the vulnerability of long-established drugs to renewed safety scrutiny: Even when causal evidence is lacking, observational findings can influence policy and public perception.

Pfizer gains access to Metsera’s oral and injectable obesity candidates, underscoring innovation in drug development and scalable manufacturing.

EMA states the new variations guidelines will streamline lifecycle management and make processing variations quicker.

CDC panel shifts vaccine policy by discouraging combined MMRV shot for young children due to increased febrile seizure risk.

The Phase IIa study will test HTL0039732 in combination with immunotherapy to boost responses in resistant solid tumors and broaden treatment choices.

Corstasis Therapeutics plans to launch the product in the United States in the fourth quarter of 2025.

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.

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.

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.

To find out how FDA’s new draft guidance, Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development, may impact the development of radiopharmaceuticals as cancer treatments, Pharmaceutical Technology® spoke with Michael Ritchie, chief commercial officer of Champions Oncology.

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.

Pharmaceutical Technology® spoke with C. 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, about recent government actions regarding kratom and concentrated 7-hydroxymitragynine (7-OH) products.

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.