Heartwire

Alert Patiromer for Hyperkalemia Recommended for Marketing in EU The potassium-binding agent had been seen to safely control mild to moderate hyperkalemia in a phase 2 trial of patients with diabetic nephropathy.
News, May 19, 2017
EMA Recommends EU Marketing of Edoxaban in Atrial Fibrillation The recommendation is for prevention of stroke and systemic embolism in atrial fibrillation and for the treatment and prevention of DVT and PE.
News, February 24, 2017
Sodium Zirconium Cyclosilicate Gets Positive EU Recommendation The Committee for Medicinal Products for Human Use recommendation was based on results of three clinical trials and one ongoing open-label trial.
News, February 24, 2017
Alert EMA Recommends Approval of Dabigatran-Specific Antidote Idarucizumab safely and effectively reverses the anticoagulant effects of dabigatran, an oral anticoagulant, in patients who require emergency surgery or who are experiencing uncontrolled/life-threatening bleeding.
News, September 25, 2015
Alert EMA Committee Backs Approval of Sacubitril/Valsartan (Entresto) The recommendation is for heart-failure patients with reduced ejection fraction. However, the organization notes it shouldn't be started in those with low blood pressure or high potassium levels.
News, September 25, 2015
Alert EMA Backs Approval of Alirocumab (Praluent) The recommendation is for patients with primary hypercholesterolemia or mixed dyslipidemia who cannot reach LDL-C goals. However, "the effect on cardiovascular morbidity has not yet been determined."
News, July 24, 2015
Alert EU Approves PCSK9 Inhibitor Evolocumab (Repatha) As the first PCSK9 inhibitor to make it to market, evolocumab is approved in a wide array of patients, including the statin intolerant and those unable to get to goal with maximally tolerated statin.
News, July 21, 2015
Alert Edoxaban (Lixiana) Approved for AF, DVT/PE in Europe The novel oral anticoagulant joins other factor Xa inhibitors and a direct thrombin inhibitor there to compete with the older vitamin-K antagonists; it's already sold in North America as Savaysa.
News, June 26, 2015
Alert Cangrelor (Kengrexal) Earns CHMP Recommendation for Use in PCI Should the European Medicines Agency follow the CHMP's recommendation, as it generally does, the intravenous P2Y12 inhibitor from the Medicines Company would be approved for the first time anywhere.
News, January 23, 2015
Apixaban (Eliquis) Approved in Europe for DVT, PE The European Commission approved apixaban following a positive review of AMPLIFY and AMPLIFY extension study from the European Medicines Agency.
News, July 29, 2014
Alert EMA Approves New Pradaxa (Dabigatran) Indications The European Medicines Agency has extended the indications for the oral anticoagulant to include treatment of DVT and PE and prevention of recurrent DVT and PE in adults.
News, June 09, 2014
Alert CHMP: No to Serelaxin (Reasanz), Yes to Riociguat (Adempas) The EMA's CHMP made two decisions this week on cardio-related drugs, saying yes to riociguat for the treatment of pulmonary hypertension, but no to serelaxin for the treatment of acute heart failure.
News, January 24, 2014
Alert Tiny Leadless Pacemaker Earns CE Mark Approval At the same time it announced the device's European approval, St Jude Medical said it has completed the acquisition of its owner and developer, Nanostim.
News, October 14, 2013
Alert EMA Panel Gives Thumbs-up to Fenofibrate/Simvastatin Combo The drug, known as Cholib, received a "positive opinion" from CHMP for two doses of the fenofibrate/simvastatin combination. A positive opinion is a prerequisite to approval by the European Commission, which has 67 days from the date of the opinion to grant approval.
News, June 28, 2013
Alert EMA Advised to Approve Lomitapide (Lojuxta) for HoF An advisory committee to the European Medicines Agent gave a "positive opinion" on the drug for treating homozygous familial hypercholesterolemia.
News, June 01, 2013
Alert COMBO 'Healing,' Sirolimus-Eluting Stent Gets CE Mark Now with the CE Mark, the stent elutes antiproliferative sirolimus but also features an anti-CD34 antibody coating to promote endothelialization, with the goal of cutting the risk of in-stent thrombosis.
News, May 29, 2013
Alert Xarelto Approved for ACS Secondary Prevention in Europe The European Commission has approved a 2.5-mg twice-daily dosage based on the ATLAS ACS 2 TIMI 51 trial.
News, May 24, 2013
Alert European Approval for Rivaroxaban for PE/DVT The European Commission has given the green light to two of the new oral anticoagulants today, for different indications.
News, November 20, 2012
Alert Synergy DES With 'Bioabsorbable' Coating Gets CE Mark The Synergy everolimus-eluting coronary stent, with its polymer coating that is absorbed and that eventually disappears after releasing the drug, has received the CE Mark, which clears the way for sale in Europe.
News, November 01, 2012
Alert Rivaroxaban Okayed for PE in Europe But the combination of phentermine and topiramate was not recommended for approval for the treatment of obesity because of concerns about long-term side effects.
News, October 19, 2012

No Results