A study in The Lancet Neurology found that dual infection with the chikungunya and Zika viruses was associated with increased risk of stroke. The findings were based on an analysis of outcomes from 201 adults in Brazil with new-onset neurological disease in 2015 and 2016.
AskBio developed a recombinant adeno-associated virus manufacturing model for gene therapies that scales down upstream manufacturing and purification processes, enables early identification of candidates that can be scaled up and minimizes risk and the need for process changes. The company has tested the model and plans to use it in future products.
The pharmaceutical industry must focus on meeting the demands of consumers and regulatory bodies, but there are still ways manufacturers can also reduce their carbon footprint, writes Ben Churchill of Crowley Carbon. Make simple changes to reduce energy use, reuse resources such as water and consider other energy sources such as wind or solar energy, Churchill writes.
A guide written by experts that outlines cleaning validation lifecycle requirements and practices is available from the International Society for Pharmaceutical Engineering. "We decided to address the topic because the expectations for cleaning validation are changing," said Jose Caraballo of Bayer US and the guide's co-lead.
Virtual reality can assist pharmaceutical manufacturers in training operators to work complicated equipment and in evaluating how drug molecules will reach a disease target. Barriers to using virtual reality include cost, technical capability and authentication of the clinical efficacy.
The Brexit transition period ends Dec. 31, and pharmaceutical companies need to be aware of changes to product registrations and authorizations for products registered in the UK, writes Cecilia Avram, senior regulatory affairs manager at Arriello. Supply chain disruptions are also possible but can be prevented by verifying the company has the correct license and documents needed to transport their products over borders, Avram writes.
To provide transgender people with quality clinical care and optimal drug therapy, health care professionals should be informed of the possible interactions between relevant pharmacotherapies and hormone therapies.
A study in the American Journal of Hematology found that many patients in an intensive care unit with SARS-CoV-2 had very high levels of clotting factor V. Researchers analyzed blood samples for more than 100 patients and found above-normal levels in almost half, with higher levels associated with increased risk of clotting in the lungs and veins.
AlloVir gained the FDA's clearance to begin a clinical trial to evaluate its allogeneic, off-the-shelf T-cell therapy ALVR109 in patients with COVID-19.
A bond sale in Europe raised $2.1 billion for Novartis on Wednesday, which ties the pharma company's interest payments to its sustainable development targets. The interest payments will increase should the drugmaker default on expanding access to therapeutics and programs focused on battling leprosy and malaria in a several developing countries.
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