The FDA's approval of Bristol Myers Squibb’s repotrectinib (Augtyro) was based on findings from the open-label, single-arm, Phase 1/2 trial TRIDENT-1, which evaluated the safety, tolerability, pharmacokinetics, and anti-tumor activity of the drug in patients with advanced solid tumors.
The Phase 3 LOCK-IT-100 clinical trial for DefenCath was recommended for an early termination based on the demonstrated efficacy in treating catheter-related bloodstream infections in adults with kidney failure administered chronic hemodialysis.
Findings suggests implementation could save time and money, but needs to be evaluated carefully.
Patient and public involvement and engagement has been used for applied research projects, including clinical trials, but has been lacking in statistical methodology research.
In addition to its latest indication, PD-L1 IHC 22C3 pharmDx can help identify patients with non–small cell lung cancer, esophageal squamous cell carcinoma, cervical cancer, head and neck squamous cell carcinoma, and triple-negative breast cancer who may derive a benefit from treatment with pembrolizumab (Keytruda).
The immense volume of available chemical compounds creates a significant challenge in the drug discovery process.
Study highlights the potential of a comprehensive, multistakeholder-driven data analysis pipeline that addresses individual data sharing, core data set sharing, and federated model sharing.
FDA expands indication for Pacira BioSciences, Inc's bupivacaine liposome injectable suspension (Exparel) as an adductor canal block and a sciatic nerve block in the popliteal fossa.
Unraveling eConsent Ethics Committees and Health Authorities submission document requirements to foster wider adoption.
A pivotal Phase 3 trial for Ixchiq showed a 98.9% seroresponse rate at 28 days following a single immunization to prevent disease caused by chikungunya virus.
Adalimumab-bwwd (Hadlima; Samsung Bioepis Co., Ltd. and Organon & Co.) could become the third Humira biosimilar deemed interchangeable, following Cyltezo and Abrilada.
Adzynma was previously granted a FDA Rare Pediatric Disease Priority Review Voucher, as well as Priority Review, Fast Track, and Orphan designations for patients with congenital thrombotic thrombocytopenic purpura.
The careful selection of sensor technology prioritized in clinical trials, considering regulatory compliance, data security, device characteristics, and the specific needs of the trials for successful and confident implementation.
The FDA granted accelerated approved in May 2021 to pembrolizumab (Keytruda) plus trastuzumab (Herceptin), fluoropyrimidine, and platinum-containing chemotherapy for the treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Fruzaqla may help to provide a significant survival benefit to patients with metastatic colorectal cancer without negatively impacting quality of life.
Tirzepatide (Zepbound; Eli Lilly and Company) is as the first and only FDA-approved medication for obesity that activates GIP and GLP-1 hormone receptors.
There is a growing need to refocus efforts on how diversity is achieved in clinical trials, because some are doing it wrong despite their best intentions.
Rexulti was found to be a well-tolerated treatment for the debilitating symptoms of agitation associated with dementia due to Alzheimer’s disease.
New research initiative will investigate the potential of zanidatamab as a monotherapy and in combination with other treatments for patients with different tumor types and stages.
Wearable digital health technologies can enhance traditional clinical outcome assessments, such as for neurology, pulmonology, cardiology, and rheumatology.
Studies with Zenith-CKD showed significant albuminuria reduction.
BI 690517 is a novel, potent, highly selective aldosterone synthase inhibitor that reduces the progression of kidney damage and lowers the risk of cardiovascular events in patients with chronic kidney disease.
Pegloticase (Krystexxa; Amgen) is approved to treat chronic gout in adults who fail to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors.
AI could present an innovative path forward in reshaping the landscape of global health strategies.
By taking on tasks such as clinical trial management, logistics, statistics, and data management, contract research organizations have helped expand the capabilities of their sponsor partners and accelerate drug development timelines.
Ongoing phase 1 dose-escalation trial of KO-2806 (FIT-001) for the treatment of patients with KRASG12C-mutated non-small cell lung cancer expected to begin dosing patients in combination with adagrasib by mid-2024.
The handling of payments is frequently an aspect of contract research organizations work that goes underappreciated and undervalued, despite its critical importance.
R&D teams need to accelerate how they conduct their research, get to a material, and get to market.
The newly approved Alinity m high risk human papillomavirus (HPV) assay is indicated to detect HPV and for use in routine cervical cancer screening per professional medical guidelines.
New laws leave consumers unprotected against third parties accessing their genetic data.
