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.
Despite a drop off in elective procedures due to the COVID-19 pandemic, Stryker Corp., of Kalamazoo, Mich., unveiled first-quarter results that came in better than analysts had presumed. BTIG’s Ryan Zimmerman noted that, unlike other companies, Stryker did not pre-announce preliminary revenue. And while investors were concerned that the company would be adversely affected by the slump in elective procedures, "the diversity of the portfolio helped to offset procedure declines in late March.”