Clinical updates, including trial initiations, enrollment status and data readouts and publications: Artios, Awkn, Biomedical Research & Bio-Products, Cara, Celyad, Cognition, Eiger, Galapagos, Immvira, Kite, Kura, Nexcella, Redx..
Strong data for pegylated interferon lambda, Eiger Biopharmaceuticals Inc.’s experimental COVID-19 treatment, boosted the company stock (NASDAQ:EIGR) 23% on Feb. 9 as the company continues to seek regulatory approval. That approval path is blocked as interferon lambda is not currently approved by the U.S. FDA for any use. In October, the company said it would not submit emergency authorization use request after feedback from the FDA.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Biogen, Bioxytran, Egret, Endogena, Gilead, Hinova, Inmagene, Neogap, Neurosense, Sage, Sandoz, Takeda.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Astrazeneca, Calliditas, GSK, Pfizer, Pharmather, Pliant, Y-mabs.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agomab, Amylyx, Anaveon, Anavex, Arrowhead, Artelo, Aulos, Biophytis, Clearside, Exscientia, First Wave, Inovio, Moonlake, Nrx, Oligomerix.
Any decision on whether to expand a five-year World Trade Organization (WTO) waiver of intellectual property rights for COVID-19 vaccines to diagnostics and therapies likely will be delayed longer than proponents had hoped. WTO members originally were scheduled to vote on expanding the waiver in December, but the deadline was extended indefinitely when key members, including the U.S., pushed for a delay.
Biophytis SA’s investigational treatment for hospitalized COVID-19 patients with severe disease, Sarconeos (BIO-101), reduced the risk of respiratory failure or early death by 44% compared to placebo, final data from a phase II/III COVA trial show, but with the disease not being quite the emergency it once was, the drug’s future could be on shaky ground.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agile, Artiva, Beactica, Edesa, Ellipses, Flag, Genoscience, Greenlight, Mesoblast, ONL, Roche, Taysha, Xortx.
The Biden administration has determined that the public health emergency (PHE) for the COVID-19 pandemic will not be renewed and thus will come to an end in the second week of May. While the end of the PHE will affect some Medicare telehealth provisions that have not been memorialized in legislation, the U.S. FDA’s ability to issue emergency use authorizations (EUAs) will not be immediately affected as that authority was invoked by a separate mechanism.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbisko, Alpha, Eisai, Escient, Huidagene, Junshi, Moderna, Nanoscope, Novelmed, Regeneron, Sandoz, Sanofi, Xeris, Zai.
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