The push for a vaccine for the COVID-19 pandemic may have no parallel in pharmaceutical history, and FDA commissioner Stephen Hahn vowed in a Senate hearing that the agency will rely on the agency’s traditional standards for scientific evidence in premarket reviews of those vaccines.
The share prices of blue-chip biopharmaceutical companies closed out the month on a high note to contribute to their stellar collective performance during the second quarter, with the BioWorld Biopharmaceutical index increasing almost 20%.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alterity, Ardelyx, Astrazeneca, Bioinvent, Mediwound, Merck, Nuvox, Oncopeptides, Oncternal, Osmotica, Prestige, Sparingvision, Synthetic Biologics, Vericel, Verrica.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Accelerator, Audentes, Basilea, Bioasis, Blueprint, Burning Rock, Camino, CNS, Cstone, Genespire, Hoth, Immatics, Marker, Meissa, Novartis, Optinose, Vertex, Ziphius.
Gilead Sciences Inc. ended the speculation Monday when it announced its no-bargaining price for remdesivir for all governments of developed countries where the drug is approved or authorized as a treatment for COVID-19.
Multiple sessions at the American Association for Cancer Research Virtual Annual Meeting II covered how COVID-19 is affecting cancer patients, from how clinical trials needed to be modified during the pandemic to how real-world evidence can play a role now and in the future.
LONDON – Scientists investigating the impact of SARS-CoV-19 on protein expression in human cells have shown that infected cells develop virus-laden membrane protrusions, or filopodia, which may explain the rapidity of viral spread through the body.
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