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.

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).

27 Mar 2014

United Therapeutics' Remodulin Injection gets approval in Japan for PAH treatment

United Therapeutics Corporation today announced that Japan's Ministry of Health, Labour and Welfare has granted approval for Remodulin (treprostinil) Injection for the treatment of pulmonary arterial hypertension (PAH) by subcutaneous and intravenous administration.

26 Mar 2014

Lung ultrasound could help determine if pregnant woman with preeclampsia is at risk for respiratory failure

18 Mar 2014

Orexo signs multi-year agreement with OptumRx and UnitedHealth Group

Orexo AB, the manufacturer of ZUBSOLV® (buprenorphine and naloxone) sublingual tablets (CIII), announced a multi-year agreement with UnitedHealth Group® and OptumRx® providing preferred coverage and reimbursement of ZUBSOLV®.

12 Mar 2014

ThromboGenics receives IWT grant to study potential new biotherapeutics for DME

ThromboGenics NV, an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines for the back of the eye, today announces that it has been awarded a €3 million grant from the Flemish agency for Innovation by Science and Technology.

10 Mar 2014

Merck reports results from Phase 2b study of investigational house dust mite sublingual immunotherapy tablet

Merck, known as MSD outside the United States and Canada, today announced results from a Phase 2b study evaluating two doses of its investigational house dust mite sublingual immunotherapy tablet (MK-8237). The data were presented for the first time during a late-breaking oral session at the 2014 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Diego.

5 Mar 2014

GTx provides clinical updates, reports financial results for fourth quarter and full year 2013

GTx, Inc. today provided a Company update and reported financial results for the fourth quarter and full year 2013.

4 Mar 2014

Doctors devise new way to treat atrial fibrillation

Doctors in the U.S. and Japan have devised a way to treat atrial fibrillation by adding a little alcohol to minimally invasive therapies that target a cluster of misbehaving nerves known to trigger arrhythmia. In the most recent Journal of the American College of Cardiology (online before print), the researchers say the new therapy may dull or stop the transmission of electrical impulses that cause atrial fibrillation.

4 Mar 2014

Bayer Yakuhin submits marketing authorization application in Japan for EYLEA Injection

Regeneron Pharmaceuticals, Inc. today announced that Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, Ltd., has submitted an application for marketing authorization for EYLEA (aflibercept) Injection for the treatment of patients with diabetic macular edema (DME) to the Japanese Ministry of Health, Labour and Welfare.

3 Mar 2014

Regeneron receives FDA acceptance for EYLEA injection for treatment of macular edema

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review the Company's supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection for the treatment of Macular Edema following Branch Retinal Vein Occlusion (BRVO).

26 Feb 2014

FDA approves Iroko Pharmaceuticals’ TIVORBEX capsules

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved TIVORBEX™ (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults.

25 Feb 2014

CSL Behring enrolls first patient in phase III study of C1-INH for prevention of HAE attacks

CSL Behring today announced it has enrolled the first patient in COMPACT, an international phase III study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor oncentrate in patients with frequent hereditary angioedema attacks (NCT01912456).

20 Feb 2014

Pharmacyclics total revenue for fourth quarter 2013 increases 113% to $123.6 million

Pharmacyclics, Inc. today reported financial results and recent developments for the quarter and year ended December 31, 2013.

20 Feb 2014

Aerpio Therapeutics doses first patient in AKB-9778 Phase 2 trial for diabetic macular edema treatment

Aerpio Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on advancing innovative therapies for vascular diseases, today announced that it has dosed the first patient in a Phase 2 trial evaluating AKB-9778, a Tie2 activator, alone and in combination with ranibizumab (Lucentis) for the treatment of diabetic macular edema (DME). AKB-9778 is a first-in-class inhibitor of human protein tyrosine phosphatase beta (HPTPβ) that activates the Tie2 pathway to promote vascular stability, preventing abnormal blood vessel growth and vascular leak.

13 Feb 2014

Edema News and Research

Further Reading

Kala Pharmaceuticals completes $22.5 million Series B financing

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

Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

FDA approves ORALAIR sublingual allergy immunotherapy tablet

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

pSivida resubmits New Drug Application for ILUVIEN

Alimera Sciences resubmits New Drug Application for ILUVIEN

United Therapeutics' Remodulin Injection gets approval in Japan for PAH treatment

Lung ultrasound could help determine if pregnant woman with preeclampsia is at risk for respiratory failure

Orexo signs multi-year agreement with OptumRx and UnitedHealth Group

ThromboGenics receives IWT grant to study potential new biotherapeutics for DME

Merck reports results from Phase 2b study of investigational house dust mite sublingual immunotherapy tablet

GTx provides clinical updates, reports financial results for fourth quarter and full year 2013

Doctors devise new way to treat atrial fibrillation

Bayer Yakuhin submits marketing authorization application in Japan for EYLEA Injection

Regeneron receives FDA acceptance for EYLEA injection for treatment of macular edema

FDA approves Iroko Pharmaceuticals’ TIVORBEX capsules

CSL Behring enrolls first patient in phase III study of C1-INH for prevention of HAE attacks

Pharmacyclics total revenue for fourth quarter 2013 increases 113% to $123.6 million

Aerpio Therapeutics doses first patient in AKB-9778 Phase 2 trial for diabetic macular edema treatment

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