With Gilead Sciences Inc. donating its existing stock of finished and unfinished remdesivir to help address the global COVID-19 pandemic through clinical trials, emergency use authorization (EUA) and compassionate use programs, patient accessibility to the investigational drug will be limited by supply, not price.
LONDON – In a potent demonstration of how COVID-19 is transforming the U.K. clinical trial landscape, 47,000 patients have been recruited to studies investigating potential treatments for the infection in a little over two months.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alume, Ascentage, Aspargo, Combioxin, Cytodyn, Freeline, Genetx, Kala, Kempharm, Marinus, Stallergenes Greer, Tolmar, Ultragenyx.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Allakos, Antibe, Aridis, Athersys, Autifony, Cel-Sci, Diamyd, GSK, Krystal, Leo, Lupin, Marinus, Newron, Novartis, Novo Nordisk, Sound Pharma, Targovax, Viriom.
Citing "known and potential benefits" of using Gilead Sciences Inc.'s remdesivir for the treatment of COVID-19 that "outweigh the known and potential risks of the drug's use," the FDA has issued an emergency use authorization (EUA) for the antiviral, currently in limited supply, according to the company. Gilead CEO Daniel O’Day, who said the company is working with partners across the globe to ramp up supply, said his team is working with "urgency and responsibility" to meet global needs for the medicine.
Researchers in Guangzhou, China, have developed a nanoparticle-based lateral flow immunoassay that quickly and accurately detects antibodies to the SARS-CoV-2 virus that causes COVID-19. The current test, which works in a similar manner to a pregnancy test, detects IgG antibodies in blood in less than 10 minutes. A proof-of-concept study appeared in Analytical Chemistry this week.
PERTH, Australia – Australia is taking several measures to increase diagnostic testing for COVID-19 and rolling out a national surveillance app as it prepares to relax social distancing measures and get back to work.
The restrictions on elective surgeries as hospitals struggle to manage the unfolding global pandemic are hitting medical device companies particularly hard. Abiomed Inc., which specializes in a tiny, minimally invasive heart pump to support heart failure patients, saw its first fiscal fourth-quarter revenue flatten as procedures were postponed. Still, U.S. revenue remained stronger than Wall Street had expected, even as ex-U.S. revenue had deeper declines.