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.
Amneal Pharmaceuticals, Metsera Strike Deal to Co-Develop Medicines for Obesity, Metabolic Diseases
October 1st 2024Partnership is expected to leverage Amneal’s global manufacturing and product development experience and Metsera’s portfolio of ultra-long acting injectables and oral nutrient-stimulated hormone analogs.
Industry Trends, Policy Challenges, and Educational Initiatives with Joseph Panetta
October 1st 2024Joseph Panetta, President and CEO of Biocom California, shares his insights on biotech industry trends, policy challenges, and educational initiatives, drawing from over 25 years of leadership in California’s thriving life sciences sector.
FDA Approves Dupixent as First-Ever Biologic Treatment for Chronic Obstructive Pulmonary Disease
September 27th 2024Dupixent was found to significantly reduce the rate of moderate to severe exacerbations of chronic obstructive pulmonary disease, according to data from the Phase III BOREAS and NOTUS trials.
Securities Litigation Arising from Alzheimer's Drug Treatments
September 25th 2024The legal challenges surrounding Biogen’s Aduhelm and Cassava Sciences’ simufilam underscore the ongoing difficulties in Alzheimer's drug development, leading to securities litigation over allegedly misleading statements about trial results and commercialization efforts.
Max Colao Shares How OncoVerity is Pioneering Oncology Solutions
September 24th 2024Max Colao, CEO of OncoVerity, discusses his extensive experience in the biotech industry and shares how his company is harnessing computational biology and machine learning to develop personalized cancer treatments that aim to reshape the future of oncology care.