Clinical Trial News

Neuralink's Blindsight implant, aiming to restore vision, received FDA's 'breakthrough device' designation. The device could enable vision restoration even for those who have lost both eyes and their optic nerve. Neuralink, founded by Elon Musk, is also testing an implant for paralyzed patients to use digital devices through thought.

Rachel George, in recovery from opioid use disorder (OUD), shares her journey, from starting opioids at 15 to participating in NIDA clinical trials. She emphasizes the importance of support and treatment, encouraging others with OUD not to give up, and highlighting the positive impact of her involvement in addiction research.

QuidelOrtho secures FDA clearance for Vitros Syphilis Assay, aiming to address the syphilis epidemic in the U.S. under new CEO Brian Blaser. The company plans to enhance production, invest in new tech, and expand markets, with a focus on adding new tests like syphilis to its portfolio.

Chinese researchers developed aTdCBE, a novel cytosine base editor lacking adenosine deaminase activity, to correct exon 55 splicing in a DMD mouse model. In vivo delivery resulted in over 40% DNA base editing at the exon 55 splice acceptor site, nearly 99% dystrophin-positive muscle fibres, and 60% dystrophin expression restoration, demonstrating efficient gene editing and significant dystrophin restoration.

Sparta Biomedical successfully implanted its Ormi device in patients with focal knee lesions in a first-in-human clinical trial, aiming to address limitations of current treatments for knee osteoarthritis.

AllClinicalTrials.com unifies US clinical trial data, simplifying access for patients and researchers. Features include a pre-screener survey, advanced search filters, and real-time notifications for new trials. Successfully supported Moderna's Phase 3 COVID-19 vaccine trial recruitment.

August 2024 saw significant data updates in CAR-T, mRNA, and GDT therapies for cancer, including a study recommending shorter monitoring after CAR T-cell therapy, BioNTech's mRNA therapy meeting primary endpoint in melanoma, long-term axi-cel data showing durable outcomes in lymphoma, Kiromic BioPharma's Deltacel generating favorable PFS data in NSCLC, and Orgenesis' CAR-T ORG-101 demonstrating efficacy and safety in ALL.

Fred Saad discusses the ARANOTE trial findings at the 2024 ESMO Annual Congress, highlighting darolutamide plus ADT's significant reduction in radiological progression or death risk in mHSPC patients. He envisions this becoming a new standard of care, expanding therapeutic options, and plans to explore earlier disease settings and combinations with other drugs.

CMS published a final notice on August 12, 2024, detailing the Transitional Coverage for Emerging Technologies (TCET) pathway, which uses existing NCD and CED processes to expedite Medicare coverage for FDA-designated Breakthrough Devices. The TCET pathway aims to balance early beneficiary access, reduced coverage uncertainty, and evidence development, accepting up to five candidates per year. Eligibility is limited to Breakthrough Devices within a Medicare benefit category, not subject to existing NCDs, and not excluded by law. The pathway includes pre-market, coverage, and post-TCET stages, with CMS aiming to finalize an NCD within six months of FDA market authorization. CMS intends to review TCET nominations quarterly, with deadlines for submission.

Benmelstobart plus anlotinib showed superior PFS (18.96 months vs 9.76 months) and ORR (71.6% vs 25.1%) compared to sunitinib in advanced RCC patients, with a safety profile consistent with each agent.