Europe’s drug regulator is reviewing reports of rare blood clots in four people who received Johnson & Johnson’s Covid-19 vaccine and expanded its probe into AstraZeneca’s shot to include reports of a bleeding condition.
AbbVie won a first-of-its-kind approval for a non-surgical treatment aimed at treating heavy menstrual bleeding due to uterine fibroids, a common non-cancerous tumor, in pre-menopausal women.
Medical supply company Baxter International agreed to buy Sanofi’s Seprafilm unit, which makes specialist surgical products, for $350 million in cash.
Shares in Solid Biosciences Inc. plunged 71 percent after a clinical trial testing the company’s gene therapy for a muscle-wasting disorder was halted for the second time in less than two years.
New data from TWILIGHT – a Phase IV independent trial funded by AstraZeneca – showed that in patients at high-bleeding risk who underwent PCI and completed three months of dual antiplatelet therapy, Brilinta monotherapy (90 mg twice daily) reduced the risk of BARC (Bleeding Academic Research Consortium) type 2, 3 or 5 bleeding compared to Brilinta plus low-dose aspirin after 12 months.
AbbVie announced the submission of a New Drug Application to the U.S. Food and Drug Administration for elagolix, an investigational GnRH antagonist for the management of heavy menstrual bleeding associated with uterine fibroids in women.
Myovant Sciences’ combination therapy met the main goal of a late-stage study testing the treatment in women with uterine fibroids.
Denmark-based Novo Nordisk snagged approval from the U.S. FDA for a new treatment for hemophilia A, though Esperoct will not be available in the United States until 2020.
Roche’s Hemlibra provided sustained bleed control in the largest pivotal study to date of children with a form of hemophilia, the Swiss drugmaker said.
U.S. regulators approved expanded use of Roche’s drug Hemlibra to include almost all patients with hemophilia A.