The U.S. Food and Drug Administration approved Genentech’s Vabysmo (faricimab-svoa) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME).
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The United States government procured more than 100 million additional COVID-19 tests from testmaker iHealth Lab Inc. as part of the White House’s plan to distribute 500 million free at-home tests across the country, the Department of Defense said Jan. 28.
The pandemic has undoubtedly altered the way of life for all Americans, but it has also shed light into the bleak statistics that are showing the opioid crisis is even worse than ever before. For the first time in history, the Centers for Disease Control and Prevention (CDC) reported that nearly 100,000 Americans died from drug overdoses over a 12-month period ending in March 2021, which was a little more than a 30 percent increase from the previous year.
Shares of Taysha Gene Therapies were down more than 10 percent after a patient’s death marred positive interim data for the company’s experimental gene therapy treatment for Sandhoff and Tay-Sachs diseases, which are two forms of GM2 gangliosidosis.
The prevailing theory about the Omicron variant is that it is going to rip through the population quickly and possibly burn out, marking the downside of the COVID-19 pandemic. But researchers are expressing concern about a subvariant of Omicron dubbed BA.2 that appears to be tearing through Denmark, just as the first Omicron wave subsided.
Eli Lilly said on Jan. 28 the company expects the U.S. Food and Drug Administration to decline the approval of expanded use of the rheumatoid arthritis drug Olumiant as a treatment for adults with moderate-to-severe eczema.
The BA.2 subtype of the Omicron coronavirus variant appears to have a substantial growth advantage over the currently predominant BA.1 type, Britain’s UK Health Security Agency said on Jan. 28.
Provention Bio is resubmitting a Biologics License Application (BLA) for teplizumab, a drug intended to delay the onset of Type 1 diabetes (T1D) in at-risk individuals, following a Type B pre-BLA resubmission meeting with the U.S. Food and Drug Administration.
Biogen is selling the company’s nearly 50 percent stake in South Korea-based Samsung Bioepis for $2.3 billion.
Regeneron Pharmaceuticals and the company’s partner Sanofi voluntarily withdrew their application with the U.S. drug regulator for the expanded use of the anti-cancer drug Libtayo in patients with advanced cervical cancer.