News

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.

In clinical trials, Cimerli met FDA standards for biosimilarity to the reference Lucentis, including safety, efficacy, and quality.

Balversa (erdafitinib) is a fibroblast growth factor inhibitor granted accelerated approval by the FDA in April 2019 for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic mutations whose disease progressed on or following one line of systemic therapy.

With variation in costs between different stakeholders in clinical trials, there is often disagreement on fair market value.

Data from the NETTER-2 trial show that first-line treatment with Lutathera plus long-acting release octreotide lowered the risk of disease progression or death by 72% in patients with advanced gastroenteropancreatic neuroendocrine tumors.

The Phase III LUNAR trial (NCT02973789) is evaluating the addition of tumor-treating fields to standard-of-care therapies in patients with non-small cell lung cancer following disease progression on or after platinum-based treatment.

In an interview with ACT editor, Andy Studna, Lieberman, Executive Director, Conferences (CHI) & Co-Founder, VP, Community and Business Development (ClinEco) discusses what ClinEco is and how the need to create it came about.

Natural language processing models are able to automate the extraction of pertinent information from a vast array of scientific literature.

Utility Therapeutics’ pivmecillinam is an oral antibiotic for the treatment of uncomplicated urinary tract infections.

New machine learning technology combines artificial intelligence with automated experiments.

Findings from ADVANCE-CIDP 1 and ADVANCE-CIDP 3 trials lead to FDA approval for HyQvia as a maintenance therapy to protect against relapse of neuromuscular disability and impairment in adult patients with chronic inflammatory demyelinating polyneuropathy.

With $13 million grant, Vanderbilt University Medical Center will lead the new multisite trial.

Casgevy is a non-viral, ex vivo CRISPR/Cas9 gene-edited cell therapy that was also recently approved for sickle cell disease.

A pair of clinical trials show the rapid and reliable efficacy of Zoryve in treating atopic dermatitis and seborrheic dermatitis.

New analysis for 2023 shows signs of post-pandemic recovery; breast cancer remains most studied disease area.

Because artificial intelligence use in healthcare is powered by patient data, it is imperative to guard privacy by verifying that security measures are in place to protect against any data breaches.

Data from the Phase III LIBERTY-AD-HAFT trial show 40% of patients with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement who were administered Dupixent achieved clear or almost clear skin on their hands and feet.

Scaling seven common digital programs inside a typical top 10 pharma company could be worth $1.4 billion to $2.2 billion in operating income over five years.

The 39th overall approval for Keytruda was based on data from the Phase III KEYNOTE-A18 trial in patients with FIGO 2014 stage III to IVA cervical cancer.

Study examines how many registered clinical trials with published protocols are also publishing their results.

An open-label, randomized, dose-optimization Phase II trial (NCT06173037) is assessing the antibody-drug conjugate RC88 to determine the optimal dosage, efficacy, and safety in patients with platinum-resistant ovarian cancer.

The efficacy of Axon Therapy was shown in a randomized controlled trial that demonstrated significant efficacy in reducing pain and numbness associated with painful diabetic neuropathy.

The revision of Annex 1 clearly calls out the use of quality risk management to identify potential risks to quality and the implementation of a contamination control strategy.

Clinical study identifies combination of 11 proteins that can predict long-term disability in patients with multiple sclerosis.

SLS009 is a CDK9 inhibitor under evaluation in an ongoing Phase I/II study in patients with relapsed or refractory acute myeloid leukemia.

Shorla Oncology’s New Drug Application for SH-105 for breast and ovarian cancers was given a Prescription Drug User Fee Act action date of June 29, 2024.

AbbVie will advance the clinical program for the investigational, dual-variable-domain IL 1α/1β antagonist lutikizumab to Phase III for the treatment of adults with moderate to severe hidradenitis suppurativa who previously failed anti-TNF therapy.