News

The FDA's complete response letter was not related to clinical trial data for efficacy or safety for zolbetuximab for the treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction.

Findings from the Phase III innovaTV 301 trial showed a favorable benefit/risk profile for Tivdak (tisotumab vedotin-tftv), as well as improved overall survival for patients with recurrent and metastatic cervical cancer who have limited treatment options.

Rinatabart sesutecan (Rina-S; PRO1184) is a novel folate receptor alpha (FRα)–targeted antibody-drug conjugate for patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

Expanding clinical trial access to include historically underrepresented ethnic and racial minorities means addressing root-cause barriers, including taxation.

Study highlights efficacy of effectively monitoring attention-deficit hyperactivity disorder treatment effects with Qbtest.

Phase III ASC4FIRST show Scemblix (asciminib) plus investigators’ choice of tyrosine kinase inhibitor produced a statistically significant response in patients newly diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

The use of modeling and biosimulation can help predict potential outcomes and improve confidence in therapeutic candidates for Alzheimer disease.

Data from the Phase III ZIRCON trial show the positron emission tomography imaging agent 89Zr-DFO-girentuximab was more effective than traditional PET/CT imaging in identifying malignant renal cell carcinoma lesions.

Merck is actively enrolling patients for investigational drugs that treat essential thrombocythemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, non-small cell lung cancer, endometrial carcinoma, and metastatic castration-resistant prostate cancer.

DCTs, data, and analytics are all areas that could be impacted in the near future.

Effects of newly implemented NIH policy on data sharing could be profound for clinical research.

EUA submission based on positive initial findings from the pivotal Phase III CANOPY clinical trial for VYD222, a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults and adolescents.

A Phase II trial (NCT02446093) is currently investigating neoadjuvant therapy with aglatimagene besadenovec plus valacyclovir with standard chemoradiation and surgery for the treatment of patients with borderline resectable or locally advanced nonmetastatic pancreatic ductal adenocarcinoma.

Industry has urgent need for an objective system that evaluates the efficacy of AI tools in clinical settings.

Teams need to keep close track of ingredients, processing parameters, and material performance so that they can use their R&D data to decide exactly which materials to make next.

Authors highlighted outsourcing and the impact of the COVID-19 pandemic in these CRO/sponsor articles from 2023.

Industry experts touched on patient needs, rare diseases, and gender analysis among other topics in these written Q&As.

Applied Clinical Trials sat down on-site with many KOLs at some of industry's largest gatherings in 2023 including SCOPE, DIA, and DPHARM.

Throughout 2023, guests of the Applied Clinical Trials podcast spoke on a number of topics including clinical research in rare disease areas, data, and artificial intelligence.

Authors in this area focused on increasing diversity in clinical trials through patient-first payment options and trial design.

In the face of chronic disease, DTx have the opportunity to provide a lifeline to patients.

Results from the Phase III OUtMATCH trial show Xolair significantly increased the amount of peanuts, milk, egg, and cashew that patients with food allergies could consume before triggering an allergic reaction.

Garadacimab was previously granted orphan drug designation for patients with hereditary angioedema by both the FDA and EMA.

Filsuvez is indicated to treat wounds associated with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa in patients aged 6 months and older.

Parents of children with cancer and limited health literacy were associated with lower comprehension of informed consent.

If approved, Merck's V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease.

Adbry is the first and only biologic FDA-approved for patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or for whom those therapies are not advisable.

A single dose of mRNA-1345 produced lower incidence of respiratory syncytial virus-associated lower respiratory tract disease and RSV-associated acute respiratory disease.