Hypotension News and Research

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FDA grants accelerated approval to NORTHERA (droxidopa) for patients with symptomatic NOH

Chelsea Therapeutics International, Ltd. today announced that the U.S. Food and Drug Administration granted accelerated approval of NORTHERA (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). NORTHERA is the first and only therapy approved by the FDA which demonstrates symptomatic benefit in patients with NOH.

18 Feb 2014

Jazz Pharmaceuticals' Versacloz now commercially available in the U.S. for schizophrenia

Jazz Pharmaceuticals plc today announced U.S. commercial availability of Versacloz (clozapine, USP) oral suspension, the first and only oral suspension clozapine for severely ill treatment-resistant schizophrenia patients or those at risk of recurrent suicidal behavior with schizophrenia or schizoaffective disorder.

11 Feb 2014

KKH doctors develop novel DIVA System for blood pressure management

New trial results1 have shown that the world's first Double Intravenous Vasopressor Automated (DIVA) System affords superior control of maternal blood pressure in women undergoing caesarean section under spinal anaesthesia, when compared with manually-administered medication to manage reduced blood pressure (vasopressor).

10 Feb 2014

Clonidine before surgery may control post-surgical pain and child's anxiety

Managing a child's pain and distress after surgery is an essential part of recovery. However, using strong painkilling medications post-surgery can put kids at risk for side effects and other complications.

31 Jan 2014

FDA approves Farxiga tablets to improve glycemic control in adults with type 2 diabetes mellitus

AstraZeneca and Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration approved Farxiga™ [far-SEE-ga] (dapagliflozin), a once-daily oral treatment indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

13 Jan 2014

GSK receives FDA approval for combination of Mekinist with Tafinlar for treatment of melanoma

GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved Mekinist® (trametinib) for use in combination with Tafinlar® (dabrafenib) for the treatment of patients with unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations.

9 Jan 2014

Sleep disorder linked to poor nonmotor status in Parkinson’s disease

The presence of rapid eye movement sleep behavior disorder is associated with more severe nonmotor symptoms in patients with early-stage Parkinson’s disease, a study shows.

8 Jan 2014

Orenitram Extended-Release Tablets get FDA approval for pulmonary arterial hypertension treatment

United Therapeutics Corporation announced today that the United States Food and Drug Administration has approved Orenitram (treprostinil) Extended-Release Tablets for the treatment of pulmonary arterial hypertension in WHO Group I patients to improve exercise capacity.

21 Dec 2013

FDA approves Baxter's FEIBA for prophylactic treatment of hemophilia patients with inhibitors

Baxter International Inc. today announced that the United States Food and Drug Administration granted approval of Baxter's FEIBA [Anti-Inhibitor Coagulant Complex], the first and only FDA-approved treatment for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B who have developed inhibitors.

From Baxter International Inc. 20 Dec 2013

Janssen receives complete response letter for canagliflozin/metformin FDC therapy for type 2 diabetes

Janssen Research & Development, LLC (Janssen) today announced it has received from the U.S. Food and Drug Administration (FDA) a complete response letter regarding its New Drug Application (NDA) for a fixed-dose combination (FDC) of canagliflozin and immediate-release metformin to treat adults with type 2 diabetes.

16 Dec 2013

Inflating balloon inside artery after stent placement increases patients' risk of serious complications

Johns Hopkins surgeons say skipping one commonly taken step during a routine procedure to insert a wire mesh stent into a partially blocked carotid artery appears to prevent patients from developing dangerously low blood pressure, an extremely slow heart rate or even a stroke or heart attack.

12 Dec 2013

Forest Laboratories to acquire exclusive rights in the U.S. for Saphris sublingual tablets

Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc. today announced that the company is acquiring exclusive rights in the United States for Saphris (asenapine) sublingual tablets, a treatment for adult patients with schizophrenia or acute bipolar mania, from Merck Sharp & Dohme B.V., a wholly owned subsidiary of Merck & Co., Inc.

3 Dec 2013

Study identifies possible link between orthostatic hypotension and atrial fibrillation

Results of a Johns Hopkins-led study have identified a possible link between a history of sudden drops in blood pressure and the most common form of irregular heartbeat.

21 Nov 2013

Calcium-channel blocker and antibiotic intake linked with small but greater risk of kidney injury

Among older adults taking a calcium-channel blocker, simultaneous use of the antibiotic clarithromycin, compared with azithromycin, was associated with a small but statistically significant greater 30-day risk of hospitalization with acute kidney injury, according to a study published by JAMA. The study is being published early online to coincide with its presentation at the American Society of Nephrology's Kidney Week 2013.

12 Nov 2013

FDA approves Prior Approval Supplement for EMBEDA Extended Release Capsules CII

Pfizer Inc. announced today that the U.S. Food and Drug Administration has approved a Prior Approval Supplement for EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII.

4 Nov 2013

FDA approves Cimzia for treatment of adults with active ankylosing spondylitis

UCB announced today that the U.S. Food and Drug Administration has approved Cimzia (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis.

18 Oct 2013

Reduced mortality rates in TBI patients linked to increased adherence to guidelines

Researchers found a significant reduction in the number of deaths of patients hospitalized in New York State with severe traumatic brain injury (TBI) between 2001 and 2009.

9 Oct 2013

Bayer HealthCare receives FDA approval for Adempas tablets

Bayer HealthCare announced today that the United States Food and Drug Administration has approved Adempas (riociguat) tablets for: (i) the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; and (ii) the treatment of adults with pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening.

9 Oct 2013

FDA approves Cimzia (certolizumab pegol) for active psoriatic arthritis

UCB announced today that the U.S. Food and Drug Administration has approved Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis.

30 Sep 2013

Financial incentives on hypertension care shows increased blood pressure control

In an examination of the effect of financial incentives on hypertension care at 12 outpatient clinics, physician-level (individual) financial incentives, but not practice-level or combined incentives, resulted in greater blood pressure control or appropriate response to uncontrolled blood pressure, according to a study in the September 11 issue of JAMA.

11 Sep 2013