Clinical Trial News

The FDA will not enforce stricter measures against clinical trial sponsors and investigators failing to register studies or report results, citing resource constraints. It prefers voluntary compliance and regulatory discretion, while agreeing to create a dashboard for non-compliance notices.

The FDA issued a clinical hold on zelnecirnon trials due to a patient's liver failure, potentially linked to the drug. Dosing and new enrollments are paused, except for RAPT's tivumecirnon oncology trial. No liver toxicity was found in other participants or nonclinical studies. RAPT investigates the case, emphasizing patient safety and FDA collaboration.

Spectral Medical extends its exclusive supply and distribution agreement with Baxter Healthcare for 10 years post U.S. FDA approval of PMX, a therapeutic device for septic shock. Baxter's commitment supports Spectral's commercialization strategy, with plans to transfer rights to a new Kidney Care company upon separation. Spectral's Tigris Trial progresses, aiming to enhance treatment for endotoxic septic shock.

Immuneering's stock rose 13% to $7.49 in premarket trading after receiving FDA fast-track designation for IMM-1-104, a treatment for pancreatic ductal adenocarcinoma, aimed at patients who have failed one line of treatment.

Mabwell's B7-H3 targeting ADC, 7MW3711, approved by FDA for advanced malignant solid tumor trials, shows promising tumor-killing effects and safety. Developed using IDDC™ platform, it features innovative components for specific tumor targeting and apoptosis induction. Mabwell, with a robust R&D system, focuses on innovative medicines across various therapeutic areas.

AstraZeneca's Tagrisso, approved by the FDA for use with chemotherapy, shows improved outcomes for EGFR-mutated non-small cell lung cancer, extending progression-free survival by nine months over monotherapy. New trial data supports its early use and effectiveness in unresectable cases, reinforcing its status as a key treatment.

A recent clinical trial has demonstrated the efficacy and safety of Houtou Jianweiling Tablet (HTJWT) in treating Chronic Non-Atrophic Gastritis (CNAG), offering a potential alternative to conventional treatments like Omeprazole. The study, conducted on Pakistani patients, found HTJWT to be non-inferior to Omeprazole in improving clinical symptoms of CNAG, with a good safety profile.

AstraZeneca and Daiichi Sankyo's BLA for datopotamab deruxtecan (Dato-DXd) was accepted in the US for treating advanced nonsquamous NSCLC post-systemic therapy, based on TROPION-Lung01 Phase III trial results showing improved PFS over docetaxel. FDA decision expected Q4 2024. Ongoing trials aim to establish Dato-DXd as a new standard in NSCLC treatment.

Global vaccine safety study links COVID-19 vaccines to small increases in rare neurological, blood, and heart-related conditions, including heart inflammation from mRNA vaccines and brain blood clots from viral-vector vaccines.

The FDA has approved the combination of osimertinib (Tagrisso) with platinum-based chemotherapy for treating patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has EGFR exon 19 deletions or exon 21 L858R mutations. This decision is based on the phase 3 FLAURA 2 study, which showed significant improvement in progression-free survival compared to osimertinib alone.