Edema News and Research

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Edema means swelling caused by fluid in your body's tissues. It usually occurs in the feet, ankles and legs, but it can involve your entire body.

UCB seeks FDA and EMA marketing authorization for Cimzia to treat active psoriatic arthritis

UCB announced today two new regulatory filings with the US Food and Drug Administration (FDA) and with the European Medicines Agency (EMA) to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA) and for adult patients with active axial spondyloarthritis (axSpA).

20 Feb 2013

Sucampo's RESCULA 0.15% now available by prescription across the U.S.

Sucampo Pharmaceuticals, Inc. today announced that RESCULA (unoprostone isopropyl ophthalmic solution) 0.15% is now available by prescription across the United States. The U.S. Food and Drug Administration (FDA) approved a sNDA for RESCULA for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension on December 7, 2012.

19 Feb 2013

Clot evacuation reduces perihematomal edema in hemorrhagic stroke

Minimally invasive surgery combined with recombinant tissue-type plasminogen activator significantly reduces perihematomal edema in patients with intracerebral hemorrhage.

18 Feb 2013

FDA approves Novartis’ Zortress to prevent organ rejection after liver transplantation in adults

Novartis announced today that the US Food and Drug Administration (FDA) has approved Zortress (everolimus) for the prophylaxis of organ rejection in adult patients receiving a liver transplant.

16 Feb 2013

Regeneron fourth quarter total revenues increase to $415 million

Regeneron Pharmaceuticals, Inc. today announced financial and operating results for the fourth quarter and full year 2012 and provided an update on development programs.

14 Feb 2013

Oleuropein aglycone reduces inflammation associated with intestinal ischemia and reperfusion

Here's another reason why you should include olive oil in your diet: A new research report published in the Journal of Leukocyte Biology suggests that at least one compound in olive oil significantly reduces intestinal ischemia (restricted blood supply) and the resulting reperfusion injury (tissue damage caused when blood supply returns).

6 Feb 2013

Risk factors for death after COPD hospitalization identified

Results from a French study suggest that a number of clinical factors may help identify patients at increased risk for death after an acute exacerbation of chronic obstructive pulmonary disease.

4 Feb 2013

Temple scientists to solve long-standing mystery in sepsis

Scientists at the Center for Translational Medicine at the Temple University School of Medicine are inching closer to solving a long-standing mystery in sepsis, a complex and often life-threatening condition that affects more than 400,000 people in the U.S. every year.

28 Jan 2013

FDA approves Takeda’s NESINA, OSENI and KAZANO for treatment of type 2 diabetes

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NESINA (alogliptin) and the fixed-dose combination (FDC) therapies OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl) for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.

28 Jan 2013

FDA approves Ampio’s IND for Optina for treatment of diabetic macular edema

Ampio Pharmaceuticals, Inc. announced today that the FDA has accepted the Company's IND for Optina™ for the treatment of diabetic macular edema (DME). Ampio plans to commence enrollment in a clinical trial in the first quarter of 2013. The FDA granted Optina™ 505(b)(2) status in July, 2012. Drugs designated under this pathway can be approved on a single trial.

22 Jan 2013

EMA adopts positive opinion for Pfizer’s bosutinib conditional approval in the EU

Pfizer Inc. announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion regarding the conditional marketing authorization of bosutinib in the European Union for the treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukemia previously treated with one or more tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

19 Jan 2013

Spain approves pSivida’s ILUVIEN to treat chronic diabetic macular edema

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, announced today that the Spanish Agency of Drugs and Medical Devices (Agencia Espanola de Medicamentos y Productos Sanitarios) granted marketing authorization to ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

18 Jan 2013

SyNAPSe® Trial by BHR Pharma deemed to have no safety issues according to DSMB

BHR Pharma, LLC announced today that the SyNAPSe® Trial's independent Data and Safety Monitoring Board (DSMB) evaluated safety data from 803 randomized patients and determined that no issues exist; therefore, the trial may continue towards its intended completion.

17 Jan 2013

No significant difference in patient outcomes with RBC transfusions using lower threshold levels

The level at which red blood cells are transfused, a common treatment in clinical practice, is often deliberated among physicians. Guidelines for blood transfusion levels were only recently issued in March 2012 diminishing some of the debate. Today, in a new section called JAMA Clinical Evidence Synopsis, the Journal of the American Medical Association (JAMA), published a summary of the systematic review of the 19 clinical trials that compare higher versus lower hemoglobin thresholds in red blood cell transfusion.

3 Jan 2013

New insights into devastating second impact syndrome

Physicians at Indiana University School of Medicine and the Northwest Radiology Network (Indianapolis, Indiana) report the case of a 17-year-old high school football player with second impact syndrome (SIS). A rare and devastating traumatic brain injury, SIS occurs when a person, most often a teenager, sustains a second head injury before recovery from an earlier head injury is complete.

2 Jan 2013

Routine reimaging unnecessary after mild head injury

Scheduling a repeat computed tomography scan for patients with mild traumatic brain injury and stable neurologic signs is unnecessary, given that it rarely changes management, say Canadian researchers.

28 Dec 2012

Scientists develop two novel model systems for human corneal endothelium

Human corneal endothelial cells (HCEnCs) form a monolayer of hexagonal cells whose main function is to maintain corneal clarity by regulating corneal hydration. Cell loss due to aging or corneal endothelial disorders, such as Fuchs dystrophy, can lead to cornea edema and blindness, resulting in the need for cornea transplants.

28 Dec 2012

AMAG seeks FDA sNDA approval for Feraheme Injection

AMAG Pharmaceuticals, Inc. today announced that it has submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use.

25 Dec 2012

Surgery poses cardiac risk to lupus women

Women with systemic lupus erythematosus are at significantly increased risk for short-term perioperative adverse cardiovascular events, find researchers.

17 Dec 2012

FDA grants accelerated approval to ARIAD’s Iclusig for treatment of CML, Ph+ ALL

ARIAD Pharmaceuticals, Inc. today announced that following a priority review, the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Iclusig (ponatinib) for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.

14 Dec 2012