News

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.

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.

Women within underserved populations with an endometrial, ovarian, or cervical cancer diagnosis were found to be underrepresented in trials.

V940 (mRNA-4157) to be evaluated in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer.

Phase II open-label, non-comparative, multicenter clinical trial shows Cresemba is effective in pediatric patients as young as 1 year of age with invasive aspergillosis and invasive mucormycotic.

Casgevy, which was approved along with Lyfgenia, is the first approval for a novel genome editing technology for sickle cell disease, which represents a significant advancement in gene therapy.

Recent study proposes consensus-based extension to the Consolidated Standards of Reporting Trials 2010 Statement for factorial trials.