A second attempt by Nabriva Therapeutics plc to win U.S. approval for the antibiotic Contepo (fosfomycin) has been undone by COVID-19. Manufacturing issues stymied the original NDA. This time, restrictions of FDA staff travel to Europe sunk the venture, leading to a new complete response letter (CRL) for the candidate as a potential treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.
COLOMBIA – The COVID-19 pandemic has put Latin America’s biotech sector under extreme pressure and highlighted flaws in the ecosystem throughout the region, not the least of which is a lack of viable networks to facilitate cooperation.
PERTH, Australia – Australia’s largest life science investment fund is pressing the government for an urgent COVID-19 response package to support the country’s AU$170 billion (US$117 billion) life sciences sector that is struggling to survive in a post-COVID-19 ecosystem.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Ampio, Ascentage, Beigene, Innovent, Nymox, Ovid, Plakous, Redhill, Regeneron, Sanofi.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Acerus, Achilles Vaccines, Adamis, Assembly, Hemostemix, Immuron, Kane Biotech, Merck, Oncolys, Oryzon, Themis, Tiziana.
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