Leverage AI to Lower Cost, Barriers to Cell Therapies
October 10th 2024Off-the-shelf cell therapies hold immense promise for revolutionizing precision medicine by offering accessible and affordable treatments. However, overcoming the immune system's rejection and navigating the FDA's approval process are crucial challenges.
Plan Ahead: Mastering Your AI Budget for 2025 Success
October 9th 2024Generative AI is just one part of the artificial intelligence and machine learning that is being used by life science organizations, emerging as a major area of interest and an area in which costs and ROI are still largely unknown.
FDA Approves Increased Dosage of Biofrontera’s Ameluz Topical Gel for Actinic Keratosis
October 7th 2024Approval was based on results from Phase I clinical safety studies, which demonstrated that using three tubes of Ameluz maintained similar safety and systemic exposure levels as one tube in treating actinic keratosis in patients undergoing photodynamic therapy.
FDA Grants Priority Review to AstraZeneca’s Calquence for Previously Untreated Mantle Cell Lymphoma
October 3rd 2024Priority Review was based on data from the ECHO Phase III trial, which demonstrated that a combination of Calquence, bendamustine, and rituximab reduced the risk of disease progression or death by 27% in patients with previously untreated mantle cell lymphoma.
FDA Approves Fresenius Kabi, Formycon’s Stelara Biosimilar for Multiple Inflammatory Diseases
October 2nd 2024Marketed as a biosimilar to Stelara, approval of Otulfi was based on clinical data demonstrating comparable efficacy in treating inflammatory conditions such as Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis.