ABBVIE

AbbVie and Gedeon Richter expand their neuropsychiatric collaboration, aiming to discover and develop novel targets. The partnership includes preclinical and clinical R&D activities, with Richter receiving an upfront payment of $25 million and potential milestone payments. Vraylar, a product of their previous collaboration, has been approved for schizophrenia, bipolar I disorder, major depressive disorder, and as adjunctive therapy for MDD. The prevalence of mental illness in the U.S. in 2022 was over 20%, highlighting the need for new therapies.

Newly described lymph node-like structures in liver tumors after immunotherapy may be crucial for treating hepatocellular carcinoma, potentially increasing the likelihood of curing the cancer, according to a study by Johns Hopkins researchers.

Amgen sets $1,665 list price for biosimilar Eylea, launching Pavblu without legal settlement. GSK invests $800 million in U.S. manufacturing expansion. Roche partners with Dyno Therapeutics for neurological gene therapy. AbbVie and Gideon Richter collaborate on neuropsychiatric treatments. Marinus Pharmaceuticals faces strategic review after Phase 3 seizure drug trial failure.

FDA approves AbbVie's Vyalev (foscarbidopa and foslevodopa) for advanced Parkinson’s disease, offering the first subcutaneous, 24-hour levodopa-based infusion in the US. Vyalev aims to manage motor fluctuations and dyskinesia, with a Phase III trial showing increased 'on' time without dyskinesia. Adverse reactions are mild to moderate, and coverage for Medicare patients is expected in 2025.

Allergan Aesthetics, an AbbVie company, received U.S. FDA approval for Botox Cosmetic to temporarily improve the appearance of moderate to severe platysma bands in adults. This marks Botox Cosmetic as the first product with four aesthetic indication areas, offering a nonsurgical, injectable option for vertical bands connecting the jaw and neck.

BOTOX® Cosmetic is now FDA-approved for treating platysma bands, making it the first aesthetic neurotoxin with four indications: forehead lines, frown lines, crow’s feet, and platysma bands. It temporarily improves appearance by reducing muscle activity. Clinical trials showed significant patient satisfaction. Allergan Aesthetics promotes it through the Allē loyalty program.

FDA approved Vyalev, a 24-hour subcutaneous infusion of foslevodopa/foscarbidopa for Parkinson’s disease motor fluctuations, produced by AbbVie. This soluble form of carbidopa/levodopa provides steady blood levels of levodopa. A clinical trial showed significant reductions in OFF time and increases in ON time without dyskinesias compared to immediate-release carbidopa/levodopa. Insurance coverage for Vyalev is evolving, and it may be suitable for those with advanced PD.

REGENXBIO's ABBV-RGX-314 gene therapy for wet AMD reduced antiVEGF injections by 97% in 9 patients with bilateral disease, with 78% injection-free post-treatment. Safety was well-tolerated, with no serious adverse events. This marks the first bilateral treatment for wet AMD, potentially offering a one-time effective treatment.

Clinical trial dropout rates are high, often due to burdensome participation. The pandemic accelerated patient-centric technologies but created data silos. Decentralized clinical trials (DCTs) emerged, though most patients prefer hybrid models. Early DCT tech was flawed, leading to hybrid solutions. Increasing trial diversity is hindered by lack of robust data. Future success hinges on integrating data, easy patient access, validated sensor data, and adhering to FDA guidelines on DCTs and diversity.