R&D/Clinical Trials

The use of RWD data in place of placebo groups is improving various elements across the clinical trial space.

Interim results from the ongoing Phase III ASSURE trial demonstrated that Livdelzi maintained a consistent biochemical response in patients with primary biliary cholangitis.

Top-line results from two pivotal Phase III trials found that MR-107A-02 significantly reduced pain intensity following herniorrhaphy and bunionectomy surgeries compared to placebo.

The aura6000 system showed a 65% responder rate at 12 months in patients with obstructive sleep apnea, defined as achieving at least a 50% reduction in apnea-hypopnea index.

Results from the Phase III MYR301 trial show that 36% of patients who achieved undetectable hepatitis delta virus levels when treated with bulevirtide maintained suppression for nearly two years.

Doug Long, VP, industry relations, IQVIA, examines shifting pharmaceutical trends, including specialty growth, biosimilar gaps, reimbursement pressure from GLP-1s, and persistent access challenges.

A new study shows that varenicline combined with brief remote counseling significantly improves vaping abstinence in in patients between 16 and 25 years of age.

In the Phase III HARMONi-6 trial, ivonescimab plus chemotherapy significantly outperformed tislelizumab plus chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer.

Results from the dual Phase III TRIUMpH trials demonstrated the statistical superiority of tegoprazan over lansoprazole in patients with erosive esophagitis and non-erosive reflux disease.

In the Phase III ARISE trial, Cobenfy administered as an adjunctive treatment to atypical antipsychotics for patients with inadequately controlled schizophrenia did not achieve statistically significant improvements.

Results from the Phase IIb SunRISe-1 study demonstrated a one-year duration of response with the TAR-200 intravesical gemcitabine-releasing system in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer.

Nigel McCracken, chief operating officer, Virax Biolabs, discusses the expansion of its ViraxImmune platform into areas such as transplant monitoring, vaccine efficacy, latent virus reactivation, and CAR T cell therapy.

Nigel McCracken, chief operating officer, Virax Biolabs explains how the ViraxImmune PAIS assay uses T cell responses and cytokine levels to detect immune dysfunction and identify viral triggers of chronic inflammation.

New Phase II data demonstrate amlitelimab’s efficacy in heterogeneous inflammatory asthma, as lunsekimig and itepekimab advance into chronic rhinosinusitis, chronic obstructive pulmonary disease, and bronchiectasis.

Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks achieved non-inferior visual acuity outcomes compared to Eylea in patients with macular edema following retinal vein occlusion.

A new study found that patients with type 2 diabetes treated with GLP-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors demonstrated lower risks of developing Alzheimer disease compared to other glucose-lowering drugs.

Nigel McCracken, chief operating officer, Virax Biolabs, discusses new findings that reveal altered cytokine activity and evidence of T cell exhaustion in long COVID patients, providing deeper insight into post-infection immune disruption.

Ziresovir is the first antiviral to demonstrate significant clinical efficacy and long-term respiratory benefits in hospitalized infants under six months of age with respiratory syncytial virus.

In the Phase III DeLLphi-304 trial, patients with small cell lung cancer administered Imdelltra achieved a statistically significant and clinically meaningful improvement in overall survival compared to standard-of-care chemotherapy.

In the Phase III ODYSSEY-HCM trial, patients treated with Camzyos for symptomatic non-obstructive hypertrophic cardiomyopathy did not show significant improvements based on Kansas City Cardiomyopathy Questionnaire – Clinical Summary Scores and peak oxygen consumption.

Nigel McCracken, chief operating officer, Virax Biolabs, discusses results from new data on the role of T cell dysfunction in post-acute infection syndromes.

Despite meeting key pharmacokinetic goals, a potential case of drug-induced liver injury led Pfizer to conclude that danuglipron’s risk-benefit profile did not support further development for chronic weight management.

Odylia Therapeutics event brings together leaders across biotech, pharma, venture capital, patient advocacy, and research sectors to address the financial and structural barriers that impede rare disease drug development.

LaShell Robinson, Head of Global Feasibility and Trial Equity at Takeda, speaks about the company's strategies to engage patients in underrepresented populations in its phase III psoriasis trials.

In the Phase III ICONIC-LEAD trial, 75% of adolescents with moderate-to-severe plaque psoriasis treated with icotrokinra achieved completely clear skin by week 24.