Therapeutic Areas

Phase III NextCOVE trial shows Moderna’s next-generation, investigational SARS-CoV-2 vaccine mRNA-1283 achieved the primary efficacy endpoint of non-inferiorty compared with Spikevax in preventing COVID-19.

The Phase III BE MOBILE 1, BE MOBILE 2, and BE MOVING trials show Bimzelx, an IL-17A and IL-17F inhibitor, produced sustained suppression of inflammation over two years and improvements in quality of life among patients with active non-radiographic axial spondyloarthritis and ankylosing spondylitis.

Seladelpar is a first-in-class, oral, selective peroxisome proliferator-activated receptor-delta agonist that has been found to improve markers of liver function and pruritis in patients with primary biliary cholangitis.

GIP receptor and GLP-1 receptor agonist tirzepatide demonstrates superiorty to placebo in MASH resolution in patients with with stage 2 or 3 fibrosis.

Dupixent (dupilumab) was previously granted priority review status as an add-on maintenance treatment for certain adults with uncontrolled chronic obstructive pulmonary disease.

Sotyktu (deucravacitinib; Bristol Myers Squibb) is an oral, selective, allosteric tyrosine kinase 2 inhibitor that produced clinically meaningful improvements in Psoriasis Area and Severity Index scores among adult patients with moderate-to-severe plaque psoriasis.

Once-weekly subcutaneous injection of CT-388 produced significant weight loss in healthy adults with obesity compared with placebo across 24 weeks in an early phase trial.

Leqembi (lecanemab-irmb) was previously granted fast track designation by the FDA for a subcutaneous version of the drug to treat Alzheimer disease in patients with mild cognitive impairment or the mild dementia stage of the disease.

In the Complete Response Letter to Dynavax, the FDA stated that the supplemental Biologic License Application based on findings from the Phase I HBV-24 trial lacked sufficient data to support a full evaluation of the efficacy or safety of a four-dose Heplisav-B regimen in adults on hemodialysis.

Administrative constraints cause FDA to push back its review of data from a pivotal Phase III trial (NCT05127434), which demonstrated favorable clinical safety and efficacy for mRNA-1345, an investigational vaccine found to reduce the incidence of RSV-associated lower respiratory tract disease.

Cell-selective, adeno-associated virus gene therapy DB-OTO restored hearing to normal levels within 24 weeks in a child born with profound genetic deafness due to variants of the otoferlin gene.

Phase I/IIa HORNBILL trial results show Boehringer Ingelheim’s novel humanized monoclonal anti-Sema3A antibody was well tolerated and showed early signs of efficacy.

Survey study assessed 58 cancer centers in the United States to identify their greatest challenges.

Data from the Phase III STRIDE-10 trial showed V116 produced immune responses against the serotypes responsible for the majority of adult invasive pneumococcal disease.

Rinvoq (upadacitinib) shows efficacy in both itch resolution and skin clearance in the treatment of patients with atopic dermatitis.

In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.

Cross-sectional comparative study of over 36,000 patients with diabetes found differences in the two groups, suggesting a need for broader patient criteria in trials.

Morbidity and Mortality Weekly Report finds that the original monovalent COVID-19 vaccines were associated with fewer hospitalizations, particularly within the first four months after vaccination, but the duration of protection from the original vaccine diminished over time.

Data from an open-label extension study show that administration of first-line Kesimpta for up to six years in treatment-naïve patients recently diagnosed with relapsing multiple sclerosis led to fewer relapses, suppressed MRI lesion activity, and fewer disability worsening events.

Phase III SURMOUNT-OSA trial data shows promise of tirzepatide, marketed as Zepbound and Mounjaro, treating the underlying disease in patients with moderate-to-severe obstructive sleep apnea.

Multicenter, open-label, 156-week extension trial finds that Qulipta (atogepant) reduced migraine days and acute medication use in patients with chronic or episodic migraine.

A full summary of the acute adverse effects of psilocybin in the treatment of depression and anxiety is vital for health care providers to provide effective patient counseling.

Findings from MONeT clinical trial show positive safety and efficacy of Abrysvo in individuals aged 18 to 59 years with an increased risk of developing severe respiratory syncytial virus-associated lower respiratory tract disease.

In the EMPACT-MI trial, Jardiance produced a 10% relative risk reduction in the primary composite endpoint of time to first hospitalization for heart failure or all-cause mortality.

In the Phase III BE HEARD I and BE HEARD II trials, a greater proportion of patients with moderate-to-severe hidradenitis suppurativa who were administered Bimzelx achieved the primary endpoint of clinically meaningful improvements in HiSCR50.

Phase III GATHER2 trial data show Izervay reduced the rate of geographic atrophy lesion growth across every month and every-other-month dosing through two years of treatment.

LPCN 1148 is an oral treatment that has shown promise preventing recurrence of overt hepatic encephalopathy and treating sarcopenia.

Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.

In part 2 of this video interview, Greg Sturmer, co-founder and CEO of Elysium Therapeutics discusses what industry should be keeping top of mind when it comes to designing and executing pain clinical studies.

mRNA-1283 was found to elicit a higher immune response against SARS-CoV-2 than Moderna's licensed COVID-19 vaccine, mRNA-1273.