Drug manufacturers should consider facility and process design principles that accelerate time to market and support regulatory compliance even while they are in the initial stages of development, writes Dan UpDyke of Rockwell Automation. Four factors -- a common network protocol, a standard and not customized equipment platform, automation of data collection and flexibility to scale up -- can alleviate challenges and make the most of single-use facilities in the future.
Drug manufacturers are developing vaccines and treatments for COVID-19 at a record pace, which presents challenges in designing and deploying data models. Experts should sift through the data to ensure the right information is relayed, rely on the right statistical approach, create models that are easy to understand and be able to explain outputs so the data is trusted, writes Matt Jones of Tessella.
An artificial intelligence platform has identified a potential COVID-19 treatment that could reduce inflammation caused by the virus and stop the cytokine storm that affects some patients. Baricitinib was identified by BenevolentAI as a promising compound, and it is in trials by Eli Lilly and Co., which owns the rights to the drug.
When it comes to free testing, laboratories can implement a policy and review process like a standard request form to help give them a structured way to assess a request and compile information, experts at Seattle Children's Hospital advise. Laboratories are also advised to meet with laboratory sales representatives to explain their policies to avoid misleading providers.
National Institute of Allergy and Infectious Diseases Director Anthony Fauci said COVID-19 vaccine candidates will start moving into late-stage clinical trials by the end of July, continuing through the summer and into fall. "We may be able to at least know whether we are dealing with a safe and effective vaccine by the early winter, late winter, beginning of 2021," Fauci said.
Research published in JAMA Neurology found that COVID-19 is eight times more likely to lead to a stroke than flu. Data showed 1.6% of 1,900 COVID-19 patients experienced a stroke, compared with 0.2% of almost 1,500 seriously ill patients with flu.
Individuals with pretreated multiple myeloma who received once-weekly selinexor, bortezomib and dexamethasone had 13.93 months' median progression-free survival, compared with 9.46 months' median PFS among those who were given twice-weekly bortezomib and dexamethasone, researchers reported at the American Society of Clinical Oncology's virtual meeting. The findings also showed significantly higher overall response rates among those in the once-weekly triplet regimen group.
A study of blood samples from 68 people with COVID-19 found high levels of markers of endothelial cell and blood platelet activation, and researchers said the findings show damage to endothelial cells that line blood vessels plays a central role in COVID-19-associated clotting. The study in the Lancet Haematology also found thrombomodulin was associated with increased rates of survival.
Novartis is building a facility in Indianapolis that will manufacture Lutathera, a drug that treats neuroendocrine tumors, due to high demand for the radioligand drug. Other radiotherapies will be also made at the plant, which will be the second US facility for Novartis when it opens in 2023.