
Why weighing all of the ‘DE&I’ components is critical at site and sponsor levels.
Jeff Sorenson and Gael Kuhn, Co-founders, Yunu, talk about ways their company has improved efficiency and accuracy in clinical trials for clients such as NCI designated cancer centers.
Despite industry-wide excitement over the involvement of retail pharmacies in clinical research, there is little information currently available on how retail pharmacies are perceived by investigative sites and patients.
Webinar Date/Time: Thu, Mar 28, 2024 12:00 PM EDT
Gilead’s Veklury (remdesivir), a nucleotide analog prodrug, was associated with lower risk of developing long-COVID.
Zilebesiran added to standard of care treatment for mild to moderate hypertension produced a clinically and statistically significant decrease in systolic blood pressure after three months.
Identifying KPIs, benchmarks, key data points, and an actionable plan are all keys to accelerating study start-up cycles.
Elysium Therapeutics’ proprietary O2P is a hydrocodone prodrug for the treatment of moderate-to-severe acute pain.
The FDA previously halted the IOV-LUN-202 trial following reports of a grade 5 serious adverse event that may have been linked to treatment with Iovance Biotherapeutics’ novel tumor infiltrating lymphocyte cell therapy LN-145, which is being evaluated in patients with advanced non–small cell lung cancer.
Jeff Sorenson and Gael Kuhn, Co-founders, Yunu, provide commentary on current obstacles associated with clinical trials and how their company is addressing them.
While little research on open-cohort designs currently exists, could this design be a solution to challenges currently seen in closed-cohort designs?
DA-1726 is a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR).
Zolgensma (onasemnogene abeparvovec), a one-time gene therapy, showed a clinical benefit for older and heavier patients with spinal muscular atrophy, many of whom were previously treated with another disease-modifying therapy.
With inequalities in palliative care provisions, recent study seeks to create a more equitable, diverse, and inclusive framework based on Patient and Public Involvement.
Data from a pair of Phase III trials indicated a progression-free survival and complete response advantage in favor of Brukinsa in patients with relapsed or refractory chronic lymphocytic leukemia.
Life sciences leaders are overcoming challenges to speed the development, launch, and education of novel medicines for rare diseases.
A study exploring healthcare preference and experience in this population group uncovers new insights and opportunities related to clinical research participation.
With significant race and sex disparities in the area of peripheral artery disease, a study shows that clinical trials often lack representative patient populations.
UCB seeks approval of Bimzelx (bimekizumab-bkzx) for psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and hidradenitis suppurativa.
A framework to understand the different approaches of trial matching solutions and the major operational and workflow challenges that all matching solutions share.
VK2735 is a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
PL9643 ophthalmic solution is a melanocortin agonist with a novel mechanism of action that produced a clinically meaningful and statistically significant reduction in pain associated with dry eye disease.
The FDA has taken a clear position with Project Optimus in shifting toward more progressive tailored approaches while rejecting antiquated study designs to evolve clinical trial strategies to better align with newer drug classes.
Epkinly (epcoritamab-bysp), subcutaneously administered, T-cell engaging, IgG1-bispecific antibody, was previously granted Breakthrough Therapy Designation for the treatment of patients with relapsed or refractory follicular lymphoma.
Gilead’s Biktarvy is now the first and only INSTI-based single-tablet regimen that is FDA approved and DHHS guideline recommended for people who are virologically suppressed with M184V/I resistance.
Survodutide produced a statistically significant improvement in metabolic dysfunction-associated steatohepatitis among 83% of those administered the drug compared to 18.2% of those given a placebo.
Biopharma company XYRA and FDA have concluded a series of Phase II meetings on managing key studies for potential atrial fibrillation therapy, budiodarone.
In an interview with ACT Editor Andy Studna, Gadi Saarony, CEO of Advarra talks about using technology to better diversify clinical trials and what to expect in the new year.
Phase Ia, open-label, escalating dose study to evaluate the safety and immunogenicity of therapeutic vaccine, TherVacB.
Trial data show Dupixent rapidly and significantly improved lung function compared to placebo in adults with uncontrolled chronic obstructive pulmonary disease with type 2 inflammation.