News

The androgen receptor inhibitor significantly increased radiological progression-free survival in combination with androgen deprivation therapy compared to placebo.

Two-year data from duo of Phase III studies show potential for Susvimo as an alternative to eye injections to treat diabetic macular edema and diabetic retinopathy.

Altuviiio is a first-in-class, high-sustained factor VIII replacement therapy, indicated for routine prophylaxis and on-demand treatment to control bleeding episodes in adults and children with hemophilia.

Mixed methods study gathered responses from study investigators to identify barriers, solutions, and opportunities associated with continuing critical care randomized trials during the pandemic.

Newly released research report from Information Services Group suggests firms are moving away from traditional, centralized trials in favor of remote technologies.

Study shows patients 80 years and older with atrial fibrillation treated with a lower dose of edoxaban experienced fewer major gastrointestinal bleeding events for each additional ischemic stroke.

deLaubenfels addresses key challenges seen by sponsors and highlights the value cough monitoring can provide.

Topline results from the 52-week open-label trial show the treatment was well tolerated with a safety profile consistent with standard-of-care.

Phase III RAISE trial shows superiorty of reteplase over alteplase in improving patients’ functional outcomes without increasing incidence of symptomatic intracranial hemorrhage and death from ischemic stroke within 4.5 hours after symptom onset.

In a Phase I-II trial, CM313 was found to inhibit antibody-dependent cell-mediated cytotoxicity on platelets while achieving long-term efficacy in patients with immune thrombocytopenia.

Del Smith, PhD, co-founder & CEO of Acclinate highlights challenges sponsors may face in light of FDA releasing its Diversity Action Plan guidance.

NF2-related schwannomatosis is a relentlessly progressive tumor predisposition syndrome with no FDA-approved treatments.

Emerging data from Phase I first-in-human, dose-escalation study showed promising survival and progression-free survival rates.

Smith shares his initial thoughts on the guidance and what its impact will be on the industry moving forward.

Once-daily formulations of the oral GLP-1 receptor agonist resulted in encouraging pharmacokinetic data for several candidates, including one showing the most favorable profile.

Study findings suggest that campaigns starting each year at the beginning of respiratory syncytial virus outbreaks, instead of continuous treatment of newborns throughout the year, may improve the usefulness of the Beyfortus program.

In the fourth and final part of this video interview, Kristy Birchard, product owner, patient engagement, YPrime discusses the importance of designing products based on the experience of patients.

In part 3 of this video interview, Kristy Birchard, product owner, patient engagement, YPrime touches on the importance of utilizing patient-reported outcomes.

Under the new agreement, a Phase II study will commence to evaluate the combination in patients with SMARCA4-mutated cancers.

Phase III innovaTV 301/ENGOT-cx12/GOG-3057 trial findings indicate that Tivdak (tisotumab vedotin-tftv) may be the preferred second- or third-line treatment option over chemotherapy for patients with recurrent cervical cancer.

In part 2 of this video interview, Kristy Birchard, product owner, patient engagement, YPrime discusses the work she is currently doing within patient centricity and how to effectively reach patient communities.

Data emerged from the IDE397 Phase II monotherapy expansion dose in methylthioadenosine phosphorylase-deletion urothelial and non-small cell lung cancer patients.

Phase III NOTUS trial data show patients with chronic obstructive pulmonary disease and type 2 inflammation administered Dupixent experienced reduced exacerbations and superior lung function compared to placebo.

In part 1 of this video interview, Kristy Birchard, product owner, patient engagement, YPrime highlights the importance of patient centricity in trial design.

Study will evaluate the potential therapy in combination with checkpoint inhibitor in patients with malignant solid tumors.

Patients administered donidalorsen experienced a lower hereditary angioedema (HAE) attack rate, which indicates the potential for prophylactic use in treating HAE.

Phase I dose escalation study expected to begin in the second half of 2024; initial data expected in the first half of 2025.

Slack discusses the complications that patients have getting enrolled in clinical trials.