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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerus, Ancora Heart, Corelink, Endra Life Sciences, Illuminoss Medical, Kardium, Livsmed, Qure.ai, Seegene.
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.