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 to review sNDA for SPRYCEL for treating adult patients with CML

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for SPRYCEL (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase.

12 Jul 2010

pSivida submits MAA for Iluvien to UK MHRA

pSivida Corp., a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences has submitted a Marketing Authorization Application (MAA) to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) for Iluvien®.

8 Jul 2010

Alimera Sciences submits MAA for Iluvien to MHRA

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals has submitted a Marketing Authorization Application to the Medicines and Healthcare products Regulatory Agency in the United Kingdom for Iluvien (fluocinolone acetonide intravitreal insert).

8 Jul 2010

FDA approves IMT to improve vision in patients with end-stage AMD

The U.S. Food and Drug Administration today announced it has approved the Implantable Miniature Telescope to improve vision in some patients with end-stage age-related macular degeneration.

7 Jul 2010

EMA completes validation process for Dyax's ecallantide MAA

Dyax Corp. announced today that the European Medicines Agency (EMA) has completed its validation process for the Marketing Authorization Application (MAA) for potential approval to market DX-88 (ecallantide) in the European Union (EU).

6 Jul 2010

Study: ONGLYZA and metformin improve HbA1c levels for adult patients with type 2 diabetes at 76-weeks

Bristol-Myers Squibb Company and AstraZeneca today announced results up to 76-weeks from a Phase 3 study of ONGLYZA(TM) (saxagliptin) as initial combination therapy with metformin, which produced long-term glycemic improvement (as measured by glycosylated hemoglobin level (HbA1c)) in treatment-naive adults with type 2 diabetes mellitus inadequately controlled on diet and exercise compared to treatment with an investigational 10 mg dose of saxagliptin or metformin alone.

2 Jul 2010

United Therapeutics, Lee's Pharmaceutical enter distribution agreement for Remodulin Injection in China

United Therapeutics Corporation and Lee's Pharmaceutical Holdings Ltd. announced today that they have entered into an exclusive agreement for the distribution of Remodulin (treprostinil) Injection in China. Remodulin is a subcutaneously or intravenously administered prostacyclin analogue for the treatment of pulmonary arterial hypertension. Lee's Pharmaceutical is a leading Chinese pharmaceutical company with both a strong cardiovascular focus and extensive commercialization experience.

2 Jul 2010

ThromboGenics to present microplasmin Phase III trial data at 28th ASRS and 10th EURETINA Congress

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, announces that data from the second Phase III trial of microplasmin (TG-MV-007) for the non-surgical treatment of vitreomacular adhesion (VMA), are to be presented at the 28th Annual Meeting of the American Society of Retina Specialists (ASRS) and the 10th EURETINA Congress.

1 Jul 2010

Research findings suggest new treatment approach to improve corneal transplants

Although it is already one of medicine's most successful transplant procedures, doctors continue to seek ways to improve corneal transplants. Now, for the first time, a team of German and British researchers have confirmed that failure and rejection of transplanted corneas are more likely in patients whose eyes exhibit abnormal vessel growth, called corneal neovascularization, prior to surgery.

1 Jul 2010

Study results of triple combination therapy in patients with diabetes and hypertension presented at ADA 2010

Preliminary results of a pre-specified subgroup study analysis of patients with diabetes and hypertension demonstrated that the investigational triple combination therapy of olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg) resulted in a statistically significant greater Least Squares mean reduction in blood pressure from baseline at week 12 (37.9/22.0 mm Hg versus 26.4-28.0/14.7-17.6 mm Hg, P less than or equal to 0.0013) as compared to corresponding dual combination therapy [olmesartan medoxomil (40 mg) / amlodipine (10 mg); olmesartan medoxomil (40 mg) / hydrochlorothiazide (25 mg); or amlodipine (10 mg) and hydrochlorothiazide (25 mg)].

1 Jul 2010

Afinitor more than doubles progression-free survival in advanced pancreatic NET: Study

Novartis Pharmaceuticals Corporation announced today that results of a Phase III study show Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival, or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET). The study, RADIANT-3, was presented at the 12th World Congress on Gastrointestinal Cancer and is part of the largest clinical trial program in patients with advanced NET.

1 Jul 2010

pSivida's licensee submits NDA to FDA for Iluvien

pSivida Corp., a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences has submitted a New Drug Application to the U.S. Food and Drug Administration for Iluvien for Diabetic Macular Edema.

1 Jul 2010

Transition commences dosing in TT-301 Phase 1 clinical study for rheumatoid arthritis, ICH, TBI

Transition Therapeutics Inc. announced today that the first patient has been dosed with drug candidate TT-301 in a Phase 1 clinical study. TT-301 is a small molecule compound that has demonstrated efficacy in preclinical models of rheumatoid arthritis, intracerebral haemorrhage and traumatic brain injury.

30 Jun 2010

Alimera submits Iluvien NDA for DME to FDA

Alimera Sciences, Inc.,, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Iluvien®, (flucocinolone acetonide intravitreal insert), its investigational, sustained drug delivery system releasing sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema (DME).

29 Jun 2010

AMAG, Takeda provide regulatory and clinical update for Feraheme Injection

AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited today provided a regulatory and clinical update for Feraheme® (ferumoxytol) Injection for intravenous (IV) use.

29 Jun 2010

Quark reports results from QPI-1007 siRNA drug study in rat ocular hypertension model of glaucoma

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced results from a second study of QPI-1007, a neuroprotective siRNA drug, in rat ocular hypertension model of glaucoma, conducted by Prof. Adriana Di Polo of the Department of Pathology and Cell Biology, Universite de Montreal.

29 Jun 2010

Merck challenges New York jury decision in federal FOSAMAX retrial

Merck & Co., Inc. today said it is challenging the decision returned by a New York jury in the retrial of a federal FOSAMAX case, Boles v. Merck. This case was the Plaintiffs' Steering Committee's top choice to take to trial and involved a Florida woman who blamed her dental and jaw problems on FOSAMAX. The first case to reach a verdict, Maley v. Merck, resulted in a defense verdict for Merck on May 5, 2010.

28 Jun 2010

JANUMET results in greater blood sugar reductions in patients with type 2 diabetes compared to pioglitazone

New data were presented at the American Diabetes Association 70th Annual Scientific Sessions from a study comparing JANUMET (sitagliptin/metformin) to pioglitazone. In this study, JANUMET resulted in significantly greater blood sugar reductions in patients with type 2 diabetes compared with pioglitazone.

28 Jun 2010

Bayer signs agreement to supply Adalat XL product to Teva Canada

Bayer Inc. and Teva Canada Limited today announced they have entered an agreement regarding Bayer's Adalat XL (nifedipine) 20, 30 and 60 mg product. Effective immediately, Bayer Inc. will supply Adalat XL exclusively to Teva Canada Limited and Teva Canada Limited will become the sole distributor in Canada of brand name Adalat XL product.

28 Jun 2010

Japan's MHLW grants full marketing authorization to REVLIMID

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy. This marketing authorization represents the first regulatory approval of REVLIMID in Japan.

25 Jun 2010

Edema News and Research

Further Reading

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

pSivida submits MAA for Iluvien to UK MHRA

Alimera Sciences submits MAA for Iluvien to MHRA

FDA approves IMT to improve vision in patients with end-stage AMD

EMA completes validation process for Dyax's ecallantide MAA

Study: ONGLYZA and metformin improve HbA1c levels for adult patients with type 2 diabetes at 76-weeks

United Therapeutics, Lee's Pharmaceutical enter distribution agreement for Remodulin Injection in China

ThromboGenics to present microplasmin Phase III trial data at 28th ASRS and 10th EURETINA Congress

Research findings suggest new treatment approach to improve corneal transplants

Study results of triple combination therapy in patients with diabetes and hypertension presented at ADA 2010

Afinitor more than doubles progression-free survival in advanced pancreatic NET: Study

pSivida's licensee submits NDA to FDA for Iluvien

Transition commences dosing in TT-301 Phase 1 clinical study for rheumatoid arthritis, ICH, TBI

Alimera submits Iluvien NDA for DME to FDA

AMAG, Takeda provide regulatory and clinical update for Feraheme Injection

Quark reports results from QPI-1007 siRNA drug study in rat ocular hypertension model of glaucoma

Merck challenges New York jury decision in federal FOSAMAX retrial

JANUMET results in greater blood sugar reductions in patients with type 2 diabetes compared to pioglitazone

Bayer signs agreement to supply Adalat XL product to Teva Canada

Japan's MHLW grants full marketing authorization to REVLIMID

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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