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.
Webinar Date/Time: Tuesday, February 6th, 2024 at 11am EST | 8am PST | 4pm GMT | 5pm CET
In an interview with ACT editor, Andy Studna, Hesterlee, Chief Research Officer at the Muscular Dystrophy Association discusses a new therapy for Duchenne Muscular Dystrophy, Vamorolone, and what sets it apart from other therapies in the market.
Phase III RUBY/ENGOT-EN6/GOG3031/NSGO trial show a statistically significant and clinically meaningful benefit for Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula across the overall patient population and among a subpopulation of patients with MMRp/MSS tumors in those with primary advanced or recurrent endometrial cancer.
Zoryve (roflumilast) topical foam, 0.3% is a highly potent and selective phosphodiesterase type 4 inhibitor in development to treat inflammatory dermatoses.
Results from the EV-302/KN-A39 clinical trial found that Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a median overall survival of 31.5 months compared to 16.1 months with platinum-based chemotherapy.
The Phase III SEACRAFT-2 trial will analyze the clinical efficacy of naporafenib compared with physician’s choice of single-agent dacarbazine, temozolomide, or trametinib among patients with NRAS-mutated metastatic melanoma who received prior treatment with an immunotherapy.
A planned analysis of the KEYNOTE-942/mRNA-4157-P201 clinical trial found that at a median follow-up of approximately three years, adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Keytruda continued to show a clinically meaningful improvement in recurrence-free survival in patients with resected high-risk melanoma.
Trial findings show Welireg lowered the risk of disease progression or death compared to Afinitor in patients with advanced renal cell carcinoma whose disease progressed following treatment with a PD-1 or PD-L1 inhibitor and a TKI.
An evolving payer and commercial landscape post-COVID-19 pandemic, increasing regulatory complexity, and the discovery of new treatments with smaller patient populations are all factors impacting the research, development, and launch of new pharmaceutical products.
This is the first FDA approval of a therapy indicated to decrease the risk of relapse in pediatric patients with high-risk neuroblastoma.
Pfizer's $43 billion deal to acquire Seagen will significantly bolster its current oncology portfolio with Seagen’s late-stage development programs and expertise in antibody-drug conjugates.
MAPS Public Benefit Corporation has submitted a new drug application to the FDA for MDMA (midomafetamine capsules) for use with psychological intervention to treat post-traumatic stress disorder.
Deal includes Icosavax’s protein virus-like particle platform technology, which could significantly improve treatments to protect against severe infectious diseases.
BL-B01D1 is a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate currently being evaluated in the global, multi-center Phase I BL-B01D1-LUNG101 trial in patients with metastatic or unresectable non-small cell lung cancer.
