Clinical Trial News
In This Month's E-News: September 2024 | Health Care Compliance Association (HCCA)
U.S. reps ask FDA about biopharmaceutical companies' clinical trials with PLA entities; NSF OIG finds ISU inappropriately charged $9,709 on six awards; UMB's Eckert agrees to 8-year debarment for research misconduct; NIH bans AI use in peer reviews; OHRP finds Emory IRB members may lack clear understanding of approval conditions; NSF updates guidance on reporting multiyear foreign gifts or contracts.
FDA approves new COVID-19 vaccine for fall and winter - WSAZ
FDA approves new Pfizer and Moderna COVID-19 vaccines for fall, targeting KP.2 variant. Symptoms remain similar to previous variants, with high risk of complications. mRNA technology promotes immune response, differing from traditional vaccines. CDC recommends updated vaccine for all Americans six months and older. Limited vaccine supply available for uninsured and underinsured patients.
AI Tools Help Avoid Patient Dropouts, Nonadherence In Clinical Trials - Inside Health Policy
AI can predict clinical trial participant dropout, helping sponsors avoid time and money loss, as demonstrated in schizophrenia and obesity drug trials by AiCure's platform.
Incyte wins FDA approval for Niktimvo, considers future - Delaware Business Times
Incyte and Syndax Pharmaceuticals secure FDA approval for Niktimvo, a treatment for chronic graft-versus-host disease, with potential sales of $650 million.
Immuron Plans Phase 2 Trial for IMM-529 following FDA review - BioSpace
Immuron completes pre-IND meeting with FDA on IMM-529 for Clostridioides difficile infection (CDI), plans IND application for 1H 2025, and targets prevention, recurrence protection, and treatment of CDI with a 3-target approach.
Sacituzumab Govitecan in Advanced Urothelial Cancer After ICI Therapy - The ASCO Post
In TROPHY-U-01 study, sacituzumab govitecan showed activity in cisplatin-ineligible patients with advanced urothelial cancer post-ICI therapy, with 32% objective response rate and manageable toxicity. Further evaluation is warranted.
FDA Approves FoundationOne Tests for Olaparib Combo in BRCA-Mutated mCRPC
The FDA approved FoundationOne®CDx and FoundationOne®Liquid CDx as companion diagnostics for olaparib plus abiraterone and prednisone in patients with BRCA-mutated metastatic CRPC, following the 2023 approval of this combination therapy based on the PROpel trial results.
FDA Awards Orphan Drug Designation to ABD-147 for Neuroendocrine Carcinoma
FDA grants orphan drug designation to ABD-147, a next-gen radiopharmaceutical targeting DLL3-expressing neuroendocrine carcinomas. Developed using the ROVEr™ platform, ABD-147 aims to deliver Actinium-225 to tumors while sparing healthy cells. Plans include a phase 1 trial in SCLC and large cell neuroendocrine carcinoma patients.
FDA approved new COVID-19 vaccines. Here's what to know and where to get them
FDA approved updated COVID-19 vaccines targeting Omicron variants JN.1 and KP.2 for ages 12+, with mRNA vaccines by Moderna and Pfizer for ages 6 months+. CDC recommends vaccination for everyone 6 months+, emphasizing importance for high-risk groups. Timing and doses depend on vaccination status. JN.1, KP.2, KP.3, and KP.3.1.1 are circulating variants. Pharmacies like CVS and Kroger offer the vaccines.
KalVista Pharmaceuticals Reports First Fiscal Quarter Results and Provides Operational Update
KalVista Pharmaceuticals provided an operational update and released financial results for the first fiscal quarter ended July 31, 2024. Highlights include the FDA's acceptance of the NDA for sebetralstat, an oral plasma kallikrein inhibitor for HAE, and the EMA's validation of the MAA. KalVista anticipates filing for approval in the UK, Japan, and other countries later in 2024, aiming for a June 2025 commercial launch. Financial results showed a net loss of $40.4 million, with R&D and G&A expenses increasing to $26.6 million and $17.6 million, respectively.
