Drug Development

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.

Drug development for rare diseases leverages genetic targeting and drives innovation and investment in pharmaceutical technology as well as precision medicine, according to Dan Williams, PhD, CEO, SynaptixBio.

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.

Radiopharmaceuticals are moving from their standard use of treating superficial tumors into radio drug conjugates that target tumors without impacting other cells in the body.

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.

Re-Vana’s drug delivery technology is designed to release treatments over a 6- to 12-month period, with the goal of reducing frequency of injections for patients.

The two companies have entered into an agreement to develop respiratory, immunology, inflammation, and cancer therapies.

The agency has given a positive recommendation for a change in the gas propellant in Trixeo Aerosphere and Riltrava Aerosphere that will have a 1000-fold reduction in global warming potential compared to the current propellant.

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

In this exclusive Drug Digest video, Deepak Bahl from Roquette and Jagruti Patel from Lonza look at strategies for accelerating early-stage development while reducing risk, approaches to speeding up timelines for complex formats without sacrificing quality, and maintaining a flexible CMC process that ensures quality.