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.

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

Quark Pharmaceuticals' siRNA drug candidates featured in two presentations at Glaucoma & Retinopathies 2010

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced that two of its siRNA drug candidates were featured in the following two presentations at the Glaucoma & Retinopathies 2010 conference, which was held June 21-22, 2010 in London, UK.

25 Jun 2010

Genentech's Lucentis for treatment of macular edema following RVO receives FDA approval

Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved Lucentis® (ranibizumab injection) for the treatment of macular edema following retinal vein occlusion (RVO). The FDA approved this new indication after a six-month Priority Review.

23 Jun 2010

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

Pfizer Inc. announced today that based on discussions with the U.S. Food and Drug Administration (FDA), it will be discontinuing commercial availability of Mylotarg® (gemtuzumab ozogamicin for Injection) (used for the treatment of relapsed acute myeloid leukemia (AML)) in the United States and that it will be voluntarily withdrawing the new drug application (NDA) for Mylotarg effective October 15, 2010.

22 Jun 2010

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

Ferring Pharmaceuticals Inc. announced today the U.S. commercial availability of LYSTEDA™ (tranexamic acid) tablets, the only non-hormonal and non-surgical therapy indicated specifically for the treatment of women with cyclic heavy menstrual bleeding (HMB). In clinical studies, LYSTEDA significantly reduced menstrual blood loss (MBL) over three and six cycles of use with the reduction seen as early as the first cycle of use.

21 Jun 2010

Dyax signs partnership agreement with Sigma-Tau to develop and commercialize subcutaneous DX-88

Dyax Corp. and Defiante Farmaceutica S.A., a subsidiary of the pharmaceutical company Sigma-Tau SpA, announced today a strategic partnership to develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema and other therapeutic indications throughout Europe, North Africa, Middle East and Russia.

21 Jun 2010

Zydus Cadila receives DCGI approval to initiate Phase I clinical trial for ZYOG1

Zydus Cadila, a global healthcare provider and one of India's leading healthcare companies has received Phase I clinical trial permission from the DCGI for ZYOG1 - a novel GLP-1 agonist. Designed and developed at the Zydus Research Centre using a unique platform technology, ZYOG1 is a novel, oral, anti-diabetic molecule.

21 Jun 2010

InteKrin Therapeutics to present INT131 SPPARM Phase 2b data at American Diabetes Association meeting

InteKrin Therapeutics Inc. announced today it will present 6 month Phase 2b clinical data for edema in diabetic patients showing differentiation for INT131, a Selective PPAR-gamma Modulator (SPPARM), from Actos® pioglitazone, at the American Diabetes Association annual meeting in Orlando, FL, Monday, June 28, 2010 at 2:45 pm EDT during the "Update on BARI 2D --Treatment of Insulin Resistance" session.

18 Jun 2010

DURATION-4 study tests superiority of BYDUREON as compared to other type 2 diabetes medications

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of BYDUREON (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications.

18 Jun 2010

St. Jude Medical commences enrollment in LAPTOP-HF study

St. Jude Medical, Inc., a global medical device company, today announced the first enrollment in its LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) study. The goal of the LAPTOP-HF study is to demonstrate that the new investigational left atrial pressure (LAP) management system safely and effectively improves outcomes in patients with heart failure (HF).

17 Jun 2010

MicroPulse protocol as effective as ETDRS in treatment of DME: Study

IRIDEX Corporation announced the recent publication of a clinical study comparing results obtained in the treatment of diabetic macular edema (DME) using an IRIDEX laser and MicroPulse™ treatment protocol to those obtained using the recognized standard of care Early Treatment of Diabetic Retinopathy Study (ETDRS) laser protocol.

17 Jun 2010

European Commission grants Orphan Medicinal Product Designation for QPI-1002

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced that the European Commission has granted Orphan Medicinal Product Designation for QPI-1002 (also referred to as "I5NP") for the prophylaxis of delayed graft function in kidney transplant patients.

16 Jun 2010

Phase III study of REVLIMID for treating patients with multiple myeloma shows improvement in PFS

Celgene International Sàrl announced that data from the planned second interim analysis (median follow-up of 21 months) of a phase III, randomized, double-blind study of continuous REVLIMID (lenalidomide) for the treatment of elderly patients with newly diagnosed multiple myeloma show improvement in progression-free survival, the primary endpoint of the study.

14 Jun 2010

Phase II study results of riociguat for CTEPH and PAH published online

Bayer HealthCare Pharmaceuticals, Inc. today announced that the study "Riociguat for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension: a phase II study" was published online this week by the European Respiratory Journal. Results of this study to assess the safety, tolerability and the feasibility of individual dose titration of riociguat were previously presented at the 2009 International Conference of the American Thoracic Society.

11 Jun 2010

Clinical data from investigational study of patients with multiple myeloma presented at ASCO

Celgene International Sàrl announced clinical data from an investigational study of patients with multiple myeloma who were younger than 65 years old and received either lenalidomide (REVLIMID), melphalan and prednisone or melphalan plus autologous stem cell transplant (MEL200) following an induction treatment of lenalidomide plus low-dose dexamethasone (Rd) were presented at the American Society of Clinical Oncology annual meeting.

11 Jun 2010

Abraxis BioScience presents phase 3 trial data on metastatic malignant melanoma

Abraxis BioScience, Inc. presented trial design information from its ongoing phase 3 registration trial of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), in melanoma, an aggressive form of skin cancer that affects more than 68,000 people in the U.S. each year.

11 Jun 2010

FDA advisory committee recommends approval of Novartis' FTY720 for relapsing MS

Today, an advisory committee of the US Food and Drug Administration (FDA) recommended approval of FTY720 (fingolimod) for the treatment of patients with relapsing multiple sclerosis, the most common form of the disease. The FDA has the option of seeking the advice of one of its advisory committees as it reviews and decides whether to approve a new treatment. The committee voted unanimously that FTY720 demonstrated substantial efficacy in treating relapsing remitting MS and that safety of the proposed 0.5 mg dose justified approval.

11 Jun 2010

Quark Pharmaceuticals closes $10M private financing round

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced the closing of a private financing by the existing investors of Quark totaling an aggregate of $10 million. The investors are funds of the prestigious SBI Holdings Group in Japan. In connection with the financing, Mr. Yoshitaka Kitao, CEO of SBI Holdings, Inc. and Mr. Robert Takeuchi, Director of SBI Investment Co., Ltd. will become members of the Quark board of directors.

10 Jun 2010

Four-year follow-up results from SPRYCEL Phase 3 study in CML-CP presented at ASCO

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced four-year follow-up results from a Phase 3 randomized, open-label, dose-optimization study of SPRYCEL® (dasatinib) in chronic-phase chronic myeloid leukemia (CML-CP) patients resistant or intolerant to Gleevec®* (imatinib mesylate). At four years, for all patients administered SPRYCEL 100 mg once daily, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%).

9 Jun 2010

Multiple presentations on nab-driven chemotherapy at 46th ASCO

Abraxis BioScience, Inc. presented abstracts describing 10 trials of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), for the treatment of breast cancer at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

9 Jun 2010

Edema News and Research

Further Reading

Japan's MHLW grants full marketing authorization to REVLIMID

Quark Pharmaceuticals' siRNA drug candidates featured in two presentations at Glaucoma & Retinopathies 2010

Genentech's Lucentis for treatment of macular edema following RVO receives FDA approval

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

Dyax signs partnership agreement with Sigma-Tau to develop and commercialize subcutaneous DX-88

Zydus Cadila receives DCGI approval to initiate Phase I clinical trial for ZYOG1

InteKrin Therapeutics to present INT131 SPPARM Phase 2b data at American Diabetes Association meeting

DURATION-4 study tests superiority of BYDUREON as compared to other type 2 diabetes medications

St. Jude Medical commences enrollment in LAPTOP-HF study

MicroPulse protocol as effective as ETDRS in treatment of DME: Study

European Commission grants Orphan Medicinal Product Designation for QPI-1002

Phase III study of REVLIMID for treating patients with multiple myeloma shows improvement in PFS

Phase II study results of riociguat for CTEPH and PAH published online

Clinical data from investigational study of patients with multiple myeloma presented at ASCO

Abraxis BioScience presents phase 3 trial data on metastatic malignant melanoma

FDA advisory committee recommends approval of Novartis' FTY720 for relapsing MS

Quark Pharmaceuticals closes $10M private financing round

Four-year follow-up results from SPRYCEL Phase 3 study in CML-CP presented at ASCO

Multiple presentations on nab-driven chemotherapy at 46th ASCO

Achieving and maintaining ISO 27001 and BS 10012 certifications

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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