Amgen, Inc.

Monopar Therapeutics Inc. acquires worldwide license for ALXN-1840 from Alexion, AstraZeneca Rare Disease for Wilson disease treatment, responsible for future development and commercialization.

The FDA delayed PDUFA dates for sotorasib (Lumakras) and obeticholic acid (Ocaliva) in metastatic colorectal cancer and primary biliary cholangitis, respectively. Sotorasib received accelerated approval for KRAS G12C mutated non–small cell lung cancer in 2021 but faced a complete response letter in 2023 for full approval. Obeticholic acid was granted accelerated approval in 2016 for primary biliary cholangitis, with an sNDA submitted for full approval. No new target action dates have been set for either drug. The phase 3 CodeBreaK 300 trial showed sotorasib plus panitumumab had a trend toward improved overall survival in metastatic colorectal cancer patients.

Alto Neuroscience's ALTO-100 drug showed no significant improvement over placebo in a major depressive disorder trial, causing a sharp drop in share value. The company plans to analyze data to determine future steps for the drug, which is also being tested for PTSD and bipolar depression. Despite the setback, analysts believe Alto's biomarker-based approach remains promising.

Amgen plans to launch its Pavblu biosimilar of Regeneron's Eylea 'at risk' after the U.S. Court of Appeals lifted a temporary injunction. Regeneron will expedite legal proceedings, with oral arguments set for January, and maintains Amgen infringes its patent rights. Analysts are surprised by Amgen's decision, considering potential damages if courts find infringement.

Novo Nordisk seeks FDA bar on compounding pharmacies making copies of its weight loss drug semaglutide, citing complexity and safety concerns. Amgen to launch biosimilar of Regeneron's eye disease drug Eylea following U.S. appeals court ruling in its favor, despite ongoing patent infringement case.

Artiva Biotherapeutics appoints Alison Moore, Ph.D., as independent Board member, leveraging her 25+ years in biotech and pharma, focusing on cell therapy manufacturing.

The FDA approved an additional presentation of Alotech and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn), a biosimilar to Stelara (ustekinumab), for intravenous infusion. This approval aligns Selarsdi's label with Stelara's indications, including psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn disease. This marks the second biosimilar of Stelara approved by the FDA, following earlier approvals of Wezlana, Pyzchiva, and Otulfi.