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.
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.
The U.S. Food and Drug Administration allowed Alnylam Pharmaceuticals Inc. to restart clinical trials on a drug to treat patients with a rare bleeding disorder.
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.
Dublin, Ireland-based Shire plans to consolidate more than 3,000 staffers spread out at over half-a-dozen locations across Massachusetts to two campuses in Cambridge and Lexington.