Don Tracy, Associate Editor

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.

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

Reportedly, data from the Vivacity-MG3 trial marks the first time an FcRn blocker demonstrated superiority over placebo in treated generalized myasthenia gravis (gMG).

Breakout session discusses the impact of incorporating decentralized elements into oncology clinical trials on data integrity, patient safety, and regulatory approvals.

The CAPItello-290 Phase III trial evaluated Truqap in combination with chemotherapy compared to placebo and chemotherapy for the treatment of locally advanced or metastatic triple-negative breast cancer.

Approval for Augtyro was based on results from the Phase I/II TRIDENT-1 trial, which demonstrated significant response rates in both tyrosine kinase inhibitor (TKI) naïve and TKI-pretreated patients.

Results of the trial found that monotherapy led to clinical benefit in 16.7% of patients, including complete and partial responses in renal cell carcinoma (RCC) patients.

Study results showed a 36% and 25% reduction in loss of asthma control (LOAC) with high and low doses of rilzabrutinib.

BTX-A51 aims to address GATA3 mutations, which affect around 15% of breast cancer patients.

Results from both trials demonstrated a significant reduction in annual asthma exacerbations over 52 weeks.

Results of the trial indicated that efsitora is non-inferior in A1C reduction compared to daily basal insulins.

A survey conducted at this year’s Pistoia Alliance conference determined that although 70% of life sciences experts acknowledge artificial intelligence’s potential, many still struggle with its initiation and implementation.

Partnership expected to utilize Walgreens’ pharmacies as recruitment and trial sites for a clinical study regarding obesity, weight issues, and type 2 diabetes, mainly in historically underrepresented groups.

Agency reports concerns amid an increase in submitted data that has been fabricated, duplicated, or unreliable from third-party laboratories.

Partnership comes amid two promising Phase III trial results for non-opioid, non-addictive medication for fibromyalgia.

A recent study showed that a multimodal machine learning approach accelerated the time in which investigators could determine the efficacy of sertraline treatment in major depressive disorder

The MightySat Fingertip Pulse Oximeter is reportedly the first pulse oximeter available without a prescription.

Device designed to address tricuspid regurgitation through a vein in the leg.

In clinical trials, patients administered Aurlumyn monotherapy experienced a significantly reduced risk of the need for amputation associated with severe frostbite.

Breakout session at SCOPE Summit 2024 discusses the potential use of artificial intelligence to improve clinical trial strategy generation.

Samsung Biologics will provide antibody development and drug substance manufacturing services for LegoChem Biosciences' antibody-drug conjugate program with hopes of submitting an Investigational New Drug application to the FDA in 2025.

Study indicated that nipocalimab demonstrated significant improvements in the symptoms of generalized myasthenia gravis and Sjögren's disease.

In an interview with ACT Associate Editor Don Tracy, Shubh Goel, Head of Immuno-Oncology and Gastrointestinal Tumors, US Oncology Business Unit, AstraZeneca, provides her thoughts on the success of the trial.

Research collaboration between DELFI and Immunocore Holdings will investigate the potential of the DELFI-TF assay in predicting the efficacy of ImmTAC-based treatments early in the therapy process.

A pivotal Phase III clinical trial is currently evaluating treatment with rusfertide, a potential first-in-class treatment for polycythemia vera.

Tremfya achieved the co-primary endpoints of Scalp-Specific Investigator Global Assessment score of 0/1 and Psoriasis Scalp Severity Index 90 response at week 16 in the trial.

NK010 is a non-genetically modified natural killer cell therapy that dislayed significant potential in inhibiting strong tumor growth on ovarian cancers in animal studies.

Satri-cel (satricabtagene autoleucel) showed a promising safety and efficacy profile in patients with gastric or gastroesophageal cancer and pancreatic cancer.

Opdivo (nivolumab) with Yervoy (ipilimumab) improved progression-free survival in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer.

New machine learning technology combines artificial intelligence with automated experiments.