U.S. FDA inspections are not always a pleasant experience, particularly when the end result is a warning letter. One company, Sea-Long Medical Systems LLC of Waxahachie, Texas, says the experience was a positive experience in that the company’s new ownership gained an important appreciation for the necessary rigors of medical device manufacturing.

The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus pandemic. They are available for free with registration. Note that we have added three critical tables, which are continuously updated:

Vaccines and therapeutics in development
Diagnostics with U.S. FDA emergency use authorization
Clinical trials of biopharma products affected by COVID-19

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acticor, Aridis, Ascentage, Cocrystal, IGM, Pepgen, Pharmazz, Precigen, Rocket.

Insilico Medicine IP Ltd. has synthesized 3C-like proteinase (3CLpro; Mpro; nsp5) (SARS-CoV-2; COVID-19 virus) inhibitors reported to be useful for the treatment of SARS-CoV-2 infection (COVID-19).

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Amylyx, Beigene, Bristol Myers Squibb, Inhibrx, Iovance, Janssen, Lexicon, Metriopharm, SK, Valneva.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: A2, Abbisko, Algiax, Alterity, Alzecure, Aum, Consynance, Debiopharm, Dermbiont, Fore, Genprex, Hansa, Harbour, Immorna, Luzhu, Pfizer, Pyxis, Revive, Selection, Springworks, Theratechnologies.

Additional early-stage research and drug discovery news in brief, from: Amplia Therapeutics, Can-Fite Biopharma, Imunon, Lixte Biotechnology, Regcell.