Two biologic therapeutic candidates met their primary endpoints in separate Phase III trials: AstraZeneca’s Ultomiris and Argenx’s Vyvgart.

Researchers at Bar-Ilan University and the Galilee Medical Center identified an association between vitamin D deficiency and severity and mortality of COVID-19.

Takeda

The U.S. Food and Drug Administration approved Takeda Pharmaceutical Company Limited’s Vonvendi [von Willebrand factor (Recombinant)] for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand disease (VWD) receiving on-demand therapy.

The U.S. Food and Drug Administration added another warning to the regulatory agency’s fact sheet for Johnson & Johnson’s COVID-19 vaccine. In other news, as the Omicron variant rips through the United States, top health officials have noted that the variant is so contagious that if you come into contact with it, you are likely to catch it.

The U.S. Food and Drug Administration on January 11 amended the fact sheet for Johnson & Johnson’s COVID-19 vaccine to include a rare risk of immune thrombocytopenia, a bleeding disorder.

Europe’s drug regulator found a possible link between Johnson & Johnson’s Covid-19 vaccine and rare blood clotting issues in adults who received doses in the United States, but backed its overall benefits against any risks.

The U.S. National Institutes of Health launched a clinical trial of fostamatinib, currently used to treat a blood platelet-destroying autoimmune disorder, in patients hospitalized with severe Covid-19.

Dova Pharmaceuticals Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for the use of Doptelet for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.

The U.S. Food and Drug Administration expanded the use of Novartis AG’s low platelets drug Promacta to treat patients with a rare, genetic blood disorder.

The U.S. Food and Drug Administration approved Rigel Pharmaceuticals Inc.’s treatment for a rare bleeding disorder.