Clinical Trial News

Accord BioPharma's BLA for DMB-3115, a biosimilar to Janssen’s Stelara®, accepted by FDA. Developed by Dong-A St and Meiji Seika Pharma, with Intas holding exclusive rights outside certain Asian countries. Accord to commercialize in US, with launch by May 2025 following FDA approval and Janssen settlement.

Johnson & Johnson's Rybrevant showed similar effectiveness to AstraZeneca's Tagrisso in treating advanced EGFR mutant NSCLC, with both drugs shrinking or halting tumor growth in about 75% of patients after a year. Rybrevant, approved in 2021 as a second-line treatment, may now also serve as an initial treatment option alongside Tagrisso, offering more effective choices to extend patient lives.

TNX-102 SL, a non-opioid analgesic, showed significant pain reduction over placebo in a Phase 3 trial and positive effects across secondary endpoints. Tonix Pharmaceuticals plans to submit an NDA to the FDA in 2024 for fibromyalgia treatment. The company also develops treatments for Long COVID, cocaine intoxication, and other diseases, with several products in clinical trials.

4SC AG received a PIP waiver from UK MHRA for resminostat, an oral treatment for advanced CTCL, eliminating the need for paediatric studies. This aids in advancing the Marketing Authorisation Application in the UK. 4SC has also filed applications with EMA, FDA, and is preparing for UK and Switzerland submissions.

Rezatapopt, an investigational oral p53 reactivator targeting TP53 Y220C mutations, is under study in the PYNNACLE Phase 1/2 trial for solid tumors. Phase 1 assessed safety, pharmacokinetics, and efficacy; Phase 1b evaluated its combination with pembrolizumab. Phase 2, currently enrolling, focuses on rezatapopt's efficacy and safety.

Annovis Bio received FDA approval to proceed with a Phase 3 clinical study of buntanetap for Parkinson's disease, following a successful Type B meeting. The FDA accepted the study's protocol and development plan, allowing longer duration trials. Buntanetap, targeting neurodegenerative diseases, showed significant improvements in Phase 2a trials for Parkinson's and Alzheimer's patients.

A systematic review of 11 RCTs found no evidence supporting early pharmacological interventions for concussion recovery within two weeks. Manual therapy and telephone counselling showed symptom improvement in two studies. High-quality RCTs on early interventions' efficacy are lacking, highlighting the need for future research on symptom-specific treatments.

FDA mandates Guillain-Barré Syndrome (GBS) warning in prescribing info for RSV vaccines Abrysvo and Arexvy, highlighting potential risk.

Study on C57BL/6 IFN-γ knockout mice treated with KDU731 showed reduced parasite shedding. Oral soft drug strategy aimed to maximize intestinal exposure while minimizing systemic exposure. Compounds 1 and EDI048, with metabolically labile spots, were tested for efficacy and systemic exposure. EDI048 demonstrated dose-dependent reduction in oocyst shedding.

A study on AML/MDS patients post-alloHSCT in CR found MRD status significantly impacts survival outcomes. MRD-negative patients had better OS, DFS, and lower CIR than MRD-positive ones. Combining MFC and molecular-PCR for MRD assessment is crucial due to the impact of inter-method discordance on prognosis.