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.
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 first half of 2018 will be pivotal for Bay Area-based Rigel Pharmaceuticals Inc. as the company awaits regulatory approval for its rare blood disorder drug and builds out the internal infrastructure to commercialize the product.
Promacta received breakthrough therapy designation from the FDA for first-line treatment of SAA.
Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion to expand the current indication for Nplate.
Rigel Pharmaceuticals Inc. said its experimental drug to treat a bleeding disorder met its main goal in the first of two late-stage trials.