DUBLIN – At the best of times, drug development is, of course, a complex problem. It is all the more demanding still in the middle of a pandemic, when the threat to human life is increasing exponentially, and health care systems are buckling under an extraordinary burden. Optimizing the development of drugs and vaccines in order to quickly generate high-quality evidence of their safety and efficacy is, therefore, a critical task, but an online webinar organized by the drug development consultants Certara LP, in conjunction with the Bill and Melinda Gates Foundation, suggested that, at this stage of the crisis, that lesson has yet to be absorbed.
“Vaccines, obviously, are the ultimate solution for pandemics,” Rino Rappuoli told BioWorld. They have, he added, “already eliminated a lot of pandemic threats – smallpox, influenza, poliomyelitis.” And the road to normalcy from the current pandemic, or any pandemic, is likely to be open only once there is a vaccine.
LONDON – DNA Electronics Ltd. (DNAe) won a U.S. FDA breakthrough device designation for its semiconductor-based DNA sequencing technology Lidia-seq and for the first assay based on the platform, which will detect bloodstream infections and antimicrobial resistance (AMR) genes at point of care.
PARIS – Medical gases specialists Air Liquide SA, of Paris, along with Peugeot SA, Schneider Electric SE and Valeo SA have joined together in a consortium to manufacture ventilators in a time when there is a critical shortage.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cipla, Diacarta, DNAe, Vapotherm, Silk Medical Aesthetics.