R&D/Clinical Trials

Clearance of ASC50 paves the way for a Phase I trial in patients with mild-to-moderate plaque psoriasis.

In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.

Results from the Phase II WILLOW trial show that enpatoran achieved a statistically significant dose-response and clinically meaningful reduction in disease activity in cutaneous and systemic lupus erythematosus with active rash.

Leandro Boer, MD, PhD, VP, US general medicines, Amgen, discusses the company's nationwide push to reduce cardiovascular risk through free LDL-C testing, public-private partnerships, and implementation science initiatives—all aimed at cutting CV events in half by 2030.

Leandro Boer, MD, PhD, VP, US general medicines, Amgen, explains why seamless communication and treatment continuity across primary care, cardiology, and rehabilitation are critical to improving outcomes and preventing care gaps for cardiovascular patients.

Leandro Boer, MD, PhD, VP, US general medicines, Amgen, discusses how new findings highlight the need for simplified decision-making in lipid management and a stronger focus on achieving LDL-C targets to help prevent heart attacks and strokes.

Leandro Boer, MD, PhD, VP, US general medicines, Amgen, explains why many high-risk Americans aged 50+ remain undertreated for cardiovascular disease, citing insurance gaps, risk misperceptions, and complex guidelines.

Leandro Boer, MD, PhD, VP, US general medicines, Amgen, discusses new real-world data showing that most high-risk cardiovascular patients in the US are not starting or intensifying lipid-lowering therapy—and few are achieving guideline-recommended LDL-C targets.

Bridging the gap in data utilization and knowledge/learning management is crucial for successful drug development.

Results from the Phase III REAL8 basket study found that once-weekly Sogroya was effective in children with growth disorders, including those born small for gestational age, with Noonan syndrome, or idiopathic short stature.

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.