Regeneron Pharmaceuticals shared positive results from the company’s Phase III trial of a candidate drug for children with homozygous familial hypercholesterolemia (HoFH), a rare, life-threatening condition characterized by elevated circulating levels of low-density lipoprotein cholesterol (LDL-C) and accelerated, premature atherosclerotic cardiovascular disease (ACVD.

FDA, stop sign

The U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.

Despite the loss of the company’s COVID-19 antibody REGEN-COV earlier in 2022, Regeneron posted a positive first quarter driven primarily by sales of Dupixent and Eylea.

The U.S. health regulator said on April 5 GlaxoSmithKline and Vir Biotechnology’s antibody therapy was no longer authorized as a COVID-19 treatment, with data suggesting it was unlikely to be effective against the dominant Omicron sub-variant in the country.

Y-mAbs Therapeutics Inc. announced that the company completed the resubmission of its Biologics License Application (BLA) for 131I-omburtamab to the U.S. FDA.

The U.S. health regulator said on March 25 the current authorized dose of GlaxoSmithKline and Vir Biotechnology’s COVID-19 antibody therapy is unlikely to be effective against the Omicron BA.2 variant.

The U.S. government will run out of supplies of COVID-19 treatments known as monoclonal antibodies as soon as late May and will have to scale back plans to get more unless Congress provides more funding, the White House said on March 15.

Clinical-stage biopharmaceutical company SAB Biotherapeutics announced an update to the design of the ongoing Phase 3 ACTIV-2 trial evaluating the clinical efficacy and safety of SAB-185 for the treatment of participants with mild-moderate COVID infections at higher risk for progression to hospitalization.

The BA.2 subvariant of Omicron, which appears to be even more transmissible than Omicron, is accounting for more than a third of global COVID-19 cases. In other news, the U.S. Food and Drug Administration placed limits on the use of GlaxoSmithKline and Vir Biotechnology’s COVID-19 antibody therapeutic, sotrovimab.

The U.S. Food and Drug Administration said on February 23 GlaxoSmithKline and Vir Biotech’s COVID-19 antibody treatment should not be used in places with circulation of variants that are not susceptible to the drug.