R&D/Clinical Trials

These therapies may provide more stable treatments than stem cell therapies.

The CEO discusses his company’s platform that helps reformulate oral solid dose medications to liquid forms.

Pharm Exec’s 20th Annual Pipeline Report examines the emerging drug development trends and surging investments in five expanding therapeutic areas.

Pathways to success for this key component of Europe’s new HTA regulation, where thinking beyond the purely technical will be critical.

Demonstrating clinical benefit is the ultimate gateway to smoother patient access.

The Phesi CEO discusses his company’s recent analysis of the most studied diseases in the world.

Data from the Phase III FRONTIER3 trial found that 98% of caregivers prefer Mim8 for hemophilia A over other treatments.

The waveLINE-010 trial will compare zilovertamab vedotin, in combination with rituximab plus cyclophosphamide, doxorubicin, and prednisone against the current standard-of-care in patients with previously untreated diffuse large B-cell lymphoma.

The Phase III trial builds on findings from prior findings that indicated Anktiva can restore T-cell function and improve overall survival in patients with advanced of metastatic non-small cell lung cancer who are PD-1 checkpoint inhibitor resistant.

Trial findings show long-term recurrence-free survival in patients with low-grade upper tract urothelial cancer treated with Jelmyto.

Cary Claiborne, CEO, Adial Pharmaceuticals, discusses AD04’s development timeline and next steps towards approval for alcohol use disorder.

Data from a Phase Ia single ascending dose study found that ASC30 demonstrated dose-proportional pharmacokinetics, a half-life of up to 60 hours, and superior pharmacokinetic properties compared to other oral GLP-1 receptor agonists.

Cary Claiborne, CEO, Adial Pharmaceuticals, discusses promising results of the AD04 study in patients with Alcohol Use Disorder

John Hood, CEO, Endeavor BioMedicines discusses partnering with advocacy groups to increase awareness of clinical trials for idiopathic pulmonary fibrosis.

Pavone discusses how these methods can be used to combat a lack of diversity in clinical trials.

While challenges remain, AI is accelerating the process by enabling researchers to identify and design new drug candidates more quickly and efficiently with applications in target discovery, structure prediction, and drug optimization.

Data from the Phase III trial program found that AXS-05 demonstrated statistically significant efficacy in treating Alzheimer disease agitation.

John Hood, CEO, Endeavor BioMedicines discusses a potential timeline on availability of ENV-101 for patients with IPF and further validation of the treatment's safety profile.

John Hood, CEO, Endeavor BioMedicines discusses the key differences between ENV-101 and currently approved IPF treatments.

Regulatory, technological, and other factors are set to have a significant impact in the coming year.

Mohamed Haitham Ayad, CEO, co-founder, SPIMA Therapeutics, discusses the company’s launch and how multiple institutions have supported its pipeline.

Results from the SURMOUNT-5 Phase IIIb trial found that Zepbound achieved an average weight loss of 20.2%, surpassing Wegovy’s 13.7%.

Results of the RESILIENT SMA study found that while taldefgrobep demonstrated clinically meaningful motor function improvements in patients with spinal muscular atrophy, the treatment arm did not achieve statistical significance at 48 weeks.

Etira’s CEO discusses recent developments in R&D and with the company’s leadership.

As the first major treatment to be approved for schizophrenia in over 30 years, Cobenfy is poised to set the stage for new approaches in treating mental health disorders.

Framework proposes three strategies designed to address the unique challenges of personalized and genetic therapies for rare diseases—and increase the probability of economic success for a new wave of potential curative treatments for these conditions.

Results from the Phase III SURMOUNT-1 study show that tirzepatide, a dual GIP and GLP-1 receptor agonist, achieved substantial average weight loss of 22.9% in patients with pre-diabetes and obesity.

Why tapping the value generated for the next set of therapies is critical.

Results from the Phase III KOMET trial found that Koselugo demonstrated a statistically significant objective response rate compared to placebo treating plexiform neurofibromas.

Phesi’s founder and president discusses methods of improving the site selection process.