News

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.

The potential treatment for chemotherapy-induced peripheral neuropathy will be evaluated in a single ascending dose study.

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.

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.

Clinical trial for BI 3034701 is expected to evaluate the safety, tolerability, and pharmacokinetics in healthy men and overweight or obese individuals aged 18-55 years old.

Preliminary results from study of small interfering RNA drug candidate, STP707, indicated the average days for stable disease in patients was 92.

Pamela Tenaerts, MD, MBA, chief scientific officer, Medable; Luke Gelinas, PhD, senior chair director, Advarra; and Pam Diamond, MD, chief medical officer & co-founder, Curavit highlight the potential impact FDA's Diversity Action Plan guidance will have on industry.

The trial aims to address the limitations of first-generation COVID-19 vaccines in preventing infections and milder diseases.

Preliminary Phase II trial data showed tobevibart and elebsiran combination achieved high rates of virologic response.

Pamela Tenaerts, MD, MBA, chief scientific officer, Medable; Luke Gelinas, PhD, senior chair director, Advarra; and Pam Diamond, MD, chief medical officer & co-founder, Curavit share their initial thoughts on the announcement of FDA's Diversity Action Plan guidance.