In an exclusive interview with BioWorld on the challenges facing a deeply divided Congress and some of the highlights of his years in the U.S. House, retiring Congressman Greg Walden (R-Ore.) said that once the COVID- 19 pandemic is over, federal policymakers should hold a summit with officials from states and major cities to look at a new preparedness partnership that would ensure the availability of strategic medical supplies.
CAJICA, Colombia – The 33 countries across Latin America, Central America and the Caribbean are taking vastly different approaches to secure, acquire and distribute COVID-19 vaccines. A handful of the region’s wealthier countries have signed deals with vaccine suppliers or plan to manufacture them, but it is unclear how others will source or distribute vaccines to protect roughly 657 million people. Many are counting on the COVAX initiative.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: BMS, Dynavax, Evaxion, Macrogenics, Modag, Oramed, Palvella, Rakuten, Revive, Serum Institute of India, Spectrum, Supernus.
TORONTO – An airway clearance device that uses acoustic sound waves to treat lung disorders and respiratory infections like cystic fibrosis (CF) is now being used to clear the lungs of patients suffering very badly from COVID-19. Developed by Montreal-based Dymedso Inc., more than 675 Frequencer acoustic devices currently being utilized across the world are assisting COVID-19 patients by removing mucous and secretions from their lungs and smaller airways.
NEW DELHI – India is taking a multipronged approach to developing and distributing vaccines against COVID-19, with at least 10 different products under development, domestically or through collaborations with foreign developers. Vaccinations are likely to begin early next year but, with a population of around 1.2 billion, it is unlikely India will be able to vaccinate everybody it needs to before the end of 2022.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acell, Artms, Medtronic, Products + Features, Quidel, Rapid Medical.
The U.S. FDA has granted emergency use authorization (EUA) for thousands of products for the COVID-19 pandemic, and the agency is legally required to advise companies of their post-pandemic options for new marketing authorization. Conversely, companies that fail to deal with inventory for expired EUAs may find themselves in the crosshairs of the FDA, whistleblowers, and federal and state attorneys, suggesting that manufacturers of devices should have a plan for dealing with unused inventories once the public health emergency comes to an end.
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