The Janssen Pharmaceutical Companies of Johnson & Johnson announced the VOYAGER PAD study met its primary efficacy and principal safety endpoints.
Netherlands-based Pharming Group N.V. denied any involvement in a potential theft of intellectual property belonging to CSL Behring from Joseph Chiao, who recently joined Pharming as medical director.
The U.S. FDA approved Janssen’s Xarelto (rivaroxaban) for preventing blood clots in acutely sick patients in hospitals who are at risk for blood clots but who are not at high risk of bleeding.
The U.S. FDA approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism in pediatric patients 1 month of age and older.
FDA accepted for Priority Review an sNDA for Xarelto for a 10 mg once-daily dose for reducing the risk of VTE after at least six months of standard anticoagulant therapy.
Espero Pharmaceuticals – a commercial-stage cardiovascular pharma company – and Armetheon – a late-clinical stage pharma company developing innovative novel drugs addressing major unmet needs in cardiovascular diseases – plan to merge.
RIDGEFIELD, Conn., Oct. 16, 2015 /PRNewswire/ — Boehringer Ingelheim Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) granted approval of Praxbind® (idarucizumab). PRAXBIND is indicated for patients treated with Pradaxa® (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. […]