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.

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Pharmacyclics, Inc. today announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval.

9 Jun 2014

SYNERA can help prevent needle stick pain associated with superficial IVs

Galen US Incorporated today announced that the U.S. Food and Drug Administration (FDA) recently approved a labeling change that allows SYNERA® (lidocaine and tetracaine) topical patch to be used at home.

4 Jun 2014

Medicare to pay for hep C screenings for baby boomers

The decision comes amid controversy surrounding the costs of new drugs to treat the blood-borne virus. Meanwhile, two studies find that Medicare could save billions if doctors switched from an expensive eye medication to a similar, much cheaper one and, also, if Part D plans were selected based on the actual drugs patients take.

4 Jun 2014

First Edition: June 3, 2014

Today's headlines include coverage of Medicare data released Monday indicating that 2012 charges for some common inpatient hospital procedures dramatically increased over the previous year.

From Medtronic 3 Jun 2014

ARIAD reports data from Iclusig Phase 2 trial in adult patients with gastrointestinal stromal tumors

ARIAD Pharmaceuticals, Inc. today announced, for the first time, data from its Phase 2 trial of Iclusig (ponatinib) in adult patients with refractory metastatic and/or unresectable gastrointestinal stromal tumors (GIST).

2 Jun 2014

Study shows high BP drugs may raise likelihood of age-related macular degeneration

There may be a connection between taking vasodilators and developing early-stage age-related macular degeneration (AMD), the leading cause of vision loss and blindness among Americans who are age 65 and older, according to a study published online in Ophthalmology, the journal of the American Academy of Ophthalmology.

29 May 2014

FDA approves Trimel’s Natesto nasal gel to treat adult males with low testosterone

Trimel Pharmaceuticals Corporation announced today that the United States Food and Drug Administration (FDA) has approved Natesto (testosterone), formerly CompleoTRT, the first and only testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

29 May 2014

Orexo US partners with inVentiv Health to market Zubsolv sublingual tablets in the US

Orexo AB announces a new partnership between Orexo US, Inc. and inVentiv Health for the commercialization of Zubsolv in the US.

20 May 2014

Eleven Biotherapeutics reports financial results and operational highlights for Q1 2014

Eleven Biotherapeutics, Inc., a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today reported financial results and operational highlights for the quarter ended March 31, 2014.

15 May 2014

Study reveals 70% of patients with diabetic retinopathy will develop macular edema

In Mexico, at least 14 million people have developed macular edema due to diabetes (DME), which like retinopathy affects central vision and can lead to blindness if not treated early .

13 May 2014

FDA approves Alexion’s Soliris drug for treatment of atypical hemolytic uremic syndrome

Alexion Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental Biologics License Application (sBLA) providing regular approval for Soliris® (eculizumab) for the treatment of adult and pediatric patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).

6 May 2014

Pregnant women with obstructive sleep apnea more likely to die in hospital

Pregnant women with obstructive sleep apnea are more than five times as likely to die in the hospital than those without the sleep disorder, a comprehensive national study by the University of South Florida researchers found.

5 May 2014

Australian and New Zealand patients with diabetes-induced vision loss to get access to new treatment

Australian and New Zealand patients suffering from vision impairment due to a type of diabetes-induced eye disease will have access to a new treatment, following a license deal between Australian biopharmaceutical company Specialised Therapeutics Australia and Alimera Sciences.

28 Apr 2014

Kala Pharmaceuticals completes $22.5 million Series B financing

Kala Pharmaceuticals, Inc., a leading developer of innovative ophthalmic products based on the company's proprietary Mucus Penetrating Particle (MPP) platform technology, today announced it has completed a $22.5 million Series B financing.

23 Apr 2014

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc.

8 Apr 2014

Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

Astellas Pharma Inc. and Medivation Inc. today announced the submission of a variation to amend the European Marketing Authorization Application for XTANDI® (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.

4 Apr 2014

FDA approves ORALAIR sublingual allergy immunotherapy tablet

GREER Laboratories, Inc., a leading developer and provider of allergy immunotherapy products and services, today announced that the U.S. Food and Drug Administration has approved ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) sublingual allergy immunotherapy tablet.

2 Apr 2014

Study of non-surgically implanted replacement pulmonary valve shows strong results

The first post-FDA approval study of a non-surgically implanted replacement pulmonary valve showed strong short- and mid-term results for the device in patients with certain congenital heart defects, according to research presented by a U-M pediatric interventional cardiologist at the American College of Cardiology's 63rd Annual Scientific Session Sunday.

1 Apr 2014

pSivida resubmits New Drug Application for ILUVIEN

pSivida Corp., a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the New Drug Application for ILUVIEN for the treatment of chronic Diabetic Macular Edema has been resubmitted to the U.S. Food and Drug Administration (FDA).

27 Mar 2014

Alimera Sciences resubmits New Drug Application for ILUVIEN

Alimera Sciences, Inc. (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it has resubmitted its New Drug Application for ILUVIEN® to the U.S. Food and Drug Administration (FDA).