Clinical Trial News

GSK's anemia pill, Jesduvroq, approved by US FDA for chronic kidney disease patients on dialysis, limiting its market and revenue potential. GSK shares increased by up to 1.2% in London.

A retrospective analysis of 105 heavily pretreated multiple myeloma patients at The Mount Sinai Hospital showed that panobinostat-based combinations yielded modest response rates and were well-tolerated, despite the drug's withdrawal from the US market.

Viva's portfolio companies have made notable progress in biopharmaceutical innovation, including funding achievements, clinical trial advancements, and strategic collaborations aimed at developing novel therapies for various diseases.

Rise Therapeutics received FDA clearance for its IND application to start a Phase 1 trial of R-3750, an oral immunotherapy for ulcerative colitis. R-3750 targets gut inflammation using a synthetic biology approach, aiming to treat IBD by engaging dendritic cells. The trial will assess safety, tolerability, and clinical activity in 36 participants.

Palbociclib plus ET showed a median PFS of 12.2 months in HR+/HER2- MBC patients, with a DCR of 90.5%. Earlier Palbociclib initiation is supported, showing benefits across treatment lines. Differences in outcomes may stem from patient demographics and prior treatments. Real-world data from China adds valuable insights, despite limitations.

FDA prioritizes sunvozertinib review for EGFR+ NSCLC treatment, citing WU-KONG1 trial's efficacy and safety data.

Alleviant Medical, Inc. secured $75M in equity financing led by S3 Ventures and RiverVest Venture Partners to fund the ALLAY-HF trial, testing the Alleviant System's safety and efficacy for heart failure treatment without implants. The trial aims to improve life quality for chronic heart failure patients globally.

A systematic review and meta-analysis of 10 studies involving over 50,000 patients demonstrates that artificial intelligence (AI) significantly improves the efficiency and accuracy of cancer clinical trial enrollment. AI algorithms, utilizing both structured and unstructured data, have shown to be highly accurate, with a summary sensitivity of 90.5% and specificity of 99.3%, offering substantial time savings and potential for increased inclusivity in clinical trials.

The combination of SEA-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab showed a 44% ORR in metastatic PDAC patients, with tolerable AEs and evidence of immune activation, suggesting potential for immunotherapy in pancreas cancer treatment.

Ropeginterferon alfa-2b, approved for polycythemia vera (PV) treatment, shows safety and efficacy in clinical trials. Emerging studies suggest higher initial doses and rapid titration may enhance tolerability and efficacy. Ongoing research explores its application in myeloproliferative neoplasms, aiming to optimize dosing for improved patient outcomes.