DUBLIN – A novel real-world study methodology that marries digital technology with a citizen science or do-it-yourself approach to “drug” procurement, formulation and administration has found – yet again – that the placebo remains one of the great wonders of the medical world.
Bionaut Labs emerged from five years in stealth mode raising $20 million to develop Bionauts, microrobots designed to deliver therapies to treat brain disorders. The financing will support the company’s therapeutic program in glioma through preclinical development and further research and development in Huntington’s disease.
The European Commission (EC) is investigating whether Teva Pharmaceutical Industries Ltd., of Petah Tikva, Israel, illegally delayed the launch and uptake of competitors to its blockbuster multiple sclerosis (MS) drug, Copaxone (glatiramer acetate).
From the time it paused inspections of drug manufacturing sites a year ago due to the COVID-19 pandemic, the FDA conducted only three foreign “mission-critical” inspections in fiscal 2020. Those were in Canada, Germany and India, according to a new U.S. Government Accountability Office report.
Amunix Pharmaceuticals Inc. CEO Angie You told BioWorld that her firm has already done most of the optimization with its unique T-cell engager platform, so that the effort now is mostly “about cranking out more INDs.”
The so-called pharma bro Martin Shkreli’s trials are far from over. The former hedge fund manager, biopharma CEO and now convicted felon is facing a class action lawsuit led by Blue Cross and Blue Shield.
CAJICA, Colombia – Cuba’s Center for the State Control of Drugs, Equipment and Medical Devices gave the green light March 3 for phase III trials of a domestically developed COVID-19 vaccine candidate, even though very little peer-reviewed information has been published about it.
The latest global regulatory news, changes and updates affecting biopharma, including: Australia eases substitution requirements; Guidance details fast-tracking modified vaccines.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kronos, Nervgen, Nicox, Novadip, Ocumension, Pfizer, RDIF, Regeneron, Sanofi.
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