Drug Development

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.

To find out how FDA’s new draft guidance, Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development, may impact the development of radiopharmaceuticals as cancer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.

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.

Orforglipron showed clinically meaningful results at 72 weeks, after three doses, in a pool of more than 3000 adults.

The investment will expand the company’s manufacturing and packaging capabilities at its Maple Grove, Minn. site, which Bora acquired in 2024 with its acquisition of Upsher-Smith Laboratories.

The acquisition expands the CDMO’s small-molecule API development and manufacturing services in the US.

Findings from a Phase III study highlight the demonstrated action of donanemab-azbt (brand name Kisunla) in slowing the decline of patients exhibiting early symptomatic Alzheimer’s disease.

The program has been transitioned to a permanent pathway that is designed to support innovative tools like artificial intelligence, wearables, and biomarkers in drug development and trials.

The company presented new data from its Alzheimer’s disease research efforts across its diagnostics and pharmaceutical portfolios at this year’s AAIC.

If action is not taken within 60 days, the White House said it would “deploy every tool in our arsenal” to improve drug pricing practices for American patients.

Help us get a better picture of how new tariffs and trade policy have impacted you and your organization.

The changes, required for safety labeling of all opioid drugs, will emphasize the risks with long-term use to combat misuse and addiction.