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Clinical Trial News

AstraZeneca and Daiichi Sankyo Partner in $6.9B Deal for Novel HER2-Targeting Cancer Drug

• AstraZeneca commits $3.5 billion upfront and up to $5.55 billion in milestone payments to co-develop trastuzumab deruxtecan, a promising antibody-drug conjugate for HER2-expressing cancers.
• The investigational drug has received FDA Breakthrough Therapy Designation for HER2-positive advanced breast cancer and shows potential across multiple tumor types including gastric, lung, and colorectal cancers.
• The collaboration aims to accelerate global development with five pivotal trials already underway, targeting a first regulatory filing in advanced breast cancer by late 2019.

Feasibility Pilot Trial on First-Pass Intubation Success Rates

A single-centre, randomised controlled feasibility pilot trial aimed to determine the feasibility for a larger definitive trial on first-pass intubation success rates. The study revealed an overall first-pass success rate of 78%, suggesting that a larger trial assessing a robust endpoint of first-pass success is feasible. The trial compared video laryngoscopy (VL) and direct laryngoscopy (DL), highlighting the need for further research to assess the effectiveness and potential biases of these techniques.

Merck KGaA Partners with Iktos to Accelerate Drug Discovery Through AI-Powered Molecular Design

• Merck KGaA has established a new collaboration with AI technology firm Iktos, leveraging deep generative models to expedite the discovery and design of novel drug compounds.
• The partnership aims to address a critical challenge in drug development by rapidly identifying molecules that meet multiple drug-like criteria for clinical testing, potentially accelerating patient access to new treatments.
• This marks Merck's second major AI initiative following their recent agreement with Cyclica, demonstrating the company's strategic commitment to incorporating artificial intelligence in their R&D process.

BrainStorm Announces First Patient in Phase 2 Clinical Trial for Progressive MS

BrainStorm Cell Therapeutics Inc. has enrolled the first patient in its Phase 2 clinical trial for progressive Multiple Sclerosis (MS), utilizing its NurOwn® technology platform. This trial represents a significant step towards addressing the unmet medical needs in progressive MS, with top-line data expected by mid-2020.

Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS

NCT03799718CompletedPhase 2
Brainstorm-Cell Therapeutics
Posted 3/13/2019

Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients

NCT03280056CompletedPhase 3
Brainstorm-Cell Therapeutics
Posted 8/28/2017

Innovations and Trials in Medical Technology

Recent advancements in medical technology include the launch of the CrossWise RF transseptal access system by Circa Scientific, completion of enrollment in a pivotal trial for Inquis Medical's Aventus thrombectomy system, a distribution agreement between Medtronic and Contego Medical, a $12 million Series A round for Relief Cardiovascular, CE mark approval for Johnson & Johnson MedTech's dual-energy catheter, a temporary pause on Varipulse PFA system cases by Johnson & Johnson MedTech, and the completion of a first-in-human study by AerWave for its lung denervation therapy.

Expanding Cancer Clinical Trial Eligibility to Include More Patients

The National Cancer Institute (NCI) and other organizations are working to broaden eligibility criteria for cancer clinical trials, aiming to include more patients and make trial results more applicable to the general population. This effort includes relaxing restrictions on age, HIV status, and other factors, while ensuring patient safety and the integrity of trial outcomes.

FDA Approves Resmetirom (Rezdiffra) for Treating MASH and Associated Fibrosis

The FDA has approved resmetirom, marketed as Rezdiffra, for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis. This marks a significant advancement in addressing a condition that affects millions globally, particularly those with type 2 diabetes and obesity.

OHSU Researchers Develop Promising Long-Lasting Malaria Vaccine Using Novel Viral Platform

• Scientists at Oregon Health & Science University have developed a novel malaria vaccine that eliminated 75-80% of parasites in vaccinated rhesus macaques, offering a potential breakthrough in the fight against a disease that kills nearly 500,000 people annually.
• The innovative approach uses cytomegalovirus (CMV) as a delivery vehicle to train immune T-cells to target the malaria parasite in the liver before it enters the bloodstream, potentially providing lifelong protection unlike current vaccines.
• While still in early research stages, the vaccine maintained its effectiveness in monkeys a year after administration, suggesting it could overcome the limited durability that has hampered previous malaria vaccine efforts.

FDA Approves Ontruzant, Samsung Bioepis and Merck's Biosimilar to Herceptin for Cancer Treatment

• The FDA has granted approval for Ontruzant, a biosimilar version of Roche's Herceptin, developed by Samsung Bioepis and to be marketed by Merck & Co in the United States.
• The biosimilar is approved for multiple indications including HER2-positive breast cancer and metastatic gastric cancer, offering a potentially more affordable treatment option.
• This marks Samsung Bioepis' first FDA-approved oncology biosimilar, joining other competitors like Celltrion/Teva and Mylan in the Herceptin biosimilar market.

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