Clinical Trial News

Acelyrin, a California biotech, announced layoffs of 40 employees, a third of its workforce, following a pivot in priorities. Despite success in a late-stage trial for a skin disorder treatment, the drug didn't outperform competitors, leading to halted investment. The company will now focus on a thyroid eye disease treatment.

HepaRegenix secures €15M for HRX-215 trials, a MKK4 inhibitor promoting liver regeneration in diseased livers. Funded by Vesalius Biocapital IV, Novo Holdings, Boehringer Ingelheim Venture Fund, and High-Tech Gründerfonds, aiming to treat liver diseases and reduce transplant needs.

FDA approves Yorvipath (palopegteriparatide) for treating hypoparathyroidism in adults. Yorvipath, a once-daily prodrug of parathyroid hormone, aims to provide continuous PTH exposure. Ascendis plans to offer patient services and anticipates initial supply in Q1 2025, potentially earlier if FDA approves existing product. Safety concerns include risks of hypercalcemia, hypocalcemia, and osteosarcoma.

FDA approves Enzeevu (aflibercept-abzv), a biosimilar to Eylea, for intravitreal injection in patients with neovascular age-related macular degeneration (nAMD). Enzeevu is a key biosimilar value driver for Sandoz, extending its leading US ophthalmology portfolio. The approval is based on comprehensive analytical, preclinical, and clinical data from the Mylight study.

scPharmaceuticals announces FDA approval of sNDA expanding Furoscix indication in heart failure, now including NYHA Class IV patients.

LENZ Therapeutics submitted an NDA to the FDA for LNZ100, an aceclidine-based eye drop for treating presbyopia, supported by positive Phase 3 CLARITY study results.

2024 has seen significant advancements and approvals in the biosimilars and pharmaceutical sectors, including the launch of Wegovy® in Australia, new indications for Opdivo®, and approvals for biosimilars in Canada and Europe. Additionally, there have been notable developments in clinical trials and legal disputes over patents.

Viva Biotech's portfolio companies, including Nerio Therapeutics, Apeiron Therapeutics, Full-Life Technologies, Arthrosi Therapeutics, and VivaVision Biotech, have announced significant advancements and collaborations in the biopharmaceutical sector, ranging from acquisitions and licensing agreements to clinical trial progress and innovative drug development.

Brazil emerges as a key hub for oncology clinical trials, with Roche leading in trials for drugs like Atezolizumab and Pertuzumab. NSCLC trials dominate, reflecting high lung cancer rates. Phase III trials prevail, supported by CROs, indicating Brazil's role in late-stage cancer treatment development.

Neurotech Pharmaceuticals announced an FDA extension of the PDUFA goal date for NT-501's BLA to March 18, 2025, to review additional data. NT-501, using the ECT platform, aims to treat MacTel, a rare neurodegenerative disease affecting central vision, by delivering CNTF for chronic retinal diseases.