Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aduro, Akorn, Allele, Chiesi Global Rare Diseases, Chinook, Cognate, Fibrogenesis, Innate Immune, Jaguar, Lakes, Novus, PDL, Protalix, R4D Biotech, Scancell, Teva.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aiviva, Algernon, Astrazeneca, Cytokinetics, Epygenix, Kyowa, Mei, Otonomy, RVL, Synthetic Biologics, Xencor.
Keeping you up to date on recent developments in diagnostics, including: Brain imaging reveals signs of childhood trauma; Buyer beware for SARS-CoV-2 antibody detection; Tumor-associated cell cluster signal cancer alert.
DUBLIN – The ongoing legal uncertainty surrounding the transfer of data from European research institutions or companies to international partners shows little sign of resolution, despite the urgency of the COVID-19 pandemic, which has engendered an extraordinary collaborative response from the global scientific community.
With phase III vaccine trials nearly enrolled and data expected soon, a half-year of expedited development efforts, plus massive government funding may soon provide the ammunition needed to effectively stop the SARS-CoV-2 scourge of 2020.
FDA enforcement of clinical research regulations has often been "light-handed, slow-moving, and secretive," a new look at the agency's enforcement track record concludes. Published today in the journal Science, the analysis said the shortcomings may be harming both patients and trial integrity.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Aegle, Akari, Baylx, Ionis, Irlab, Kadmon, Pfizer, Provention, Solid, Teneobio, Zosano.
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