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.

Findings from Abraxis BioScience's phase 3 ABRAXANE trial in patients with NSCLC presented at ASCO

Abraxis BioScience, Inc. announced today that findings from their phase 3 randomized trial of nanoparticle albumin bound driven chemotherapy, nab-paclitaxel (ABRAXANE for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension) plus carboplatin, showed a statistically significant 31 percent improvement in overall response rate when compared with Taxol (paclitaxel) injection plus carboplatin in the first-line treatment of patients with non-small cell lung cancer.

8 Jun 2010

Researchers present data from Phase II study of lenalidomide in patients with untreated CLL at ASCO

Celgene International Sàrl today announced that researchers presented data from an investigator-initiated Phase II study of lenalidomide (REVLIMID) in untreated patients with chronic lymphocytic leukemia at the annual meeting of the American Society of Clinical Oncology.

8 Jun 2010

Ranibizumab improves vision in patients with visual impairment due to DME: RESTORE study

Results from a new major diabetes eye health study may have the potential to change the way vision loss due to diabetic macular edema, a serious and devastating complication of diabetes, is treated. One year results from the RESTORE study show that 37 per cent of patients treated with ranibizumab only and 43 per cent of those treated with ranibizumab plus laser therapy, had a significant improvement in visual acuity of 10 letters or more on an eye chart, compared to 16 per cent of patients treated with laser alone - the current standard treatment for visual impairment due to DME.

7 Jun 2010

EDEMA4 study results of KALBITOR for treatment of acute attacks of HAE published

Dyax Corp. announced today the publication of results from its second Phase 3, placebo-controlled trial, known as EDEMA4, evaluating KALBITOR (ecallantide) for the treatment of acute attacks of hereditary angioedema. The results, published in the June 2010 issue of the Annals of Allergy, Asthma, and Immunology, indicate that KALBITOR is effective in ameliorating HAE attacks, resolving associated symptoms and preventing attack progression.

7 Jun 2010

Exelixis reports updated interim data from trials of XL765 small molecule inhibitor of PI3K and mTOR

Exelixis, Inc. today reported updated interim data from three ongoing trials of XL765 (SAR245409), an orally available small molecule inhibitor of phosphoinositide-3-kinase (PI3K) and mTOR. Activation of the PI3K pathway is a frequent event in human tumors, promoting cell proliferation, survival, and resistance to chemotherapy and radiotherapy.

7 Jun 2010

Microplasmin exhibits potential to cure 50% of patients with macular hole

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, announces that further data from the first successful Phase III trial with microplasmin (TG-MV-006) for the non-surgical treatment of vitreomacular adhesion (VMA) were presented at the World Ophthalmology Congress by Dr. Matthew Benz, MD (The Methodist Hospital, Houston, Texas, U.S.)

7 Jun 2010

Celgene reports initial data from investigator-initiated study of REVLIMID

Celgene International Sàrl today announced that initial data from an investigator-initiated study of REVLIMID (lenalidomide) plus Rituxan (rituximab) in patients with newly diagnosed indolent B-cell non-Hodgkin's lymphoma (NHL) were presented at the annual meeting of the American Society of Clinical Oncology.

5 Jun 2010

Researchers present clinical outcomes of lenalidomide in patients with large B-cell lymphoma

Celgene International Sàrl today announced researchers at the annual meeting of the American Society of Clinical Oncology presented data from an evaluation of lenalidomide (REVLIMID) in patients with diffuse large B-cell lymphoma either with a germinal center B-cell or non-germinal center B-cell phenotype.

5 Jun 2010

Antiemetic-regimen with fosaprepitant injection provides similar protection against CINV as oral EMEND

Merck announced today results from a new non-inferiority trial of an antiemetic regimen containing fosaprepitant dimeglumine administered as a single intravenous (IV) 150-mg dose in combination with a 5-HT3 antagonist and dexamethasone compared with a three-day regimen of aprepitant with a 5-HT3 antagonist and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving a first cycle of cisplatin-based chemotherapy.

4 Jun 2010

Promising results of ABRAXANE for bladder cancer support efficacy of nab-driven chemotherapy

Abraxis BioScience, Inc. announced today that findings from a phase 1 randomized trial demonstrated that the nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension) is well-tolerated and active in the second-line treatment of high-grade, non-muscle-invasive bladder cancer that has been refractory to standard intra-bladder infusion (intravesical) therapy.

4 Jun 2010

Alimera Sciences provides new data from Iluvien Phase 3 FAME clinical trials for DME

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that a new analysis of data from its Phase 3 (FAME) clinical trials for Iluvien, the company's investigational intravitreal insert being studied for diabetic macular edema (DME), indicates that patient vision continues to improve significantly over 30 months.

28 May 2010

CSL Behring granted authorization to market Berinert for HAE in Italy and Luxembourg

CSL Behring announced today it has been granted national marketing authorization in Italy and Luxembourg to market Berinert® for the treatment of acute hereditary angioedema (HAE) attacks in any body location. This latest authorization brings the number of countries to 28 (in Europe, Asia, North America, South America and Australia) in which Berinert is now licensed.

28 May 2010

POZEN receives milestone payment from AstraZeneca for FDA approval of VIMOVO

POZEN Inc., announced today the receipt of a $20 million milestone payment from AstraZeneca for the U.S. Food and Drug Administration approval of VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets on April 30th. POZEN will transfer ownership of the Investigational New Drug application and New Drug Application for VIMOVO to AstraZeneca over the next few weeks.

26 May 2010

Genzyme's Lumizyme for Pompe disease receives FDA marketing approval

Genzyme Corporation announced today that the FDA has granted U.S. marketing approval for Lumizyme™ (alglucosidase alfa), produced at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. Lumizyme is the first treatment approved in the United States specifically to treat patients with late-onset Pompe disease.

25 May 2010

Bayer's Adalat XL product and Mylan's nifedipine extended release 60 mg not bioequivalent: Study

Bayer Inc. today responded to Professor Marvin Meyer's letter to the editor, entitled: "Critical questions concerning the validity of the Bayer study report of differences in bioavailability between 60 mg of nifedipine osmotic push-pull systems after fasted and fed administration" and published in the online edition of the International Journal of Clinical Pharmacology and Therapeutics. Bayer responded to the clinical relevance of the differences in formulation and dissolution behaviour and the delayed absorption of Mylan's extended release nifedipine.

25 May 2010

Salix Pharmaceuticals announces availability of Xifaxan tablets for reducing risk of overt HE recurrence

Salix Pharmaceuticals, Ltd. today announced the availability of Xifaxan (rifaximin) 550 mg tablets for the reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. Those HE patients may now fill their Xifaxan 550 mg prescriptions in U.S. pharmacies and should speak with their doctors about this important treatment option.

24 May 2010

Data evaluating use of nab-paclitaxel for treatment of pancreatic cancer to be presented at ASCO 2010

Abraxis BioScience, Inc., a fully integrated biotechnology company, previously announced it will be presenting more than 30 studies, including new clinical data evaluating the use of nanoparticle albumin bound driven chemotherapy, nab-paclitaxel (ABRAXANE for Injectable suspension; paclitaxel protein albumin-bound particles for injectable suspension) for the treatment of pancreatic cancer at the 46th Annual Meeting of the American Society of Clinical Oncology in Chicago.

21 May 2010

New data highlighting Pfizer's approach to cancer drug development to be presented at ASCO meeting

Pfizer Oncology will present new data highlighting the company's focused approach to cancer drug development through the identification and validation of molecular targets. These results will be presented at the 46th Annual American Society of Clinical Oncology meeting in Chicago from June 4-8.

21 May 2010

Provectus to present further positive data from PV-10 Phase 2 clinical trial for metastatic melanoma at ASCO

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, has announced further positive data on the first forty subjects in its Phase 2 clinical trial of PV-10 for metastatic melanoma, with an objective response ("OR") observed in 61% of subjects and a mean Progression Free Survival ("PFS") of at least 11.1 months among those subjects achieving an OR.

21 May 2010

FDA approves ZYMAXID ophthalmic solution for treatment of bacterial conjunctivitis

Allergan, Inc. today announced that the United States Food and Drug Administration has approved ZYMAXID (gatifloxacin ophthalmic solution) 0.5%, a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms; Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumonia.

20 May 2010

Edema News and Research

Further Reading

Findings from Abraxis BioScience's phase 3 ABRAXANE trial in patients with NSCLC presented at ASCO

Researchers present data from Phase II study of lenalidomide in patients with untreated CLL at ASCO

Ranibizumab improves vision in patients with visual impairment due to DME: RESTORE study

EDEMA4 study results of KALBITOR for treatment of acute attacks of HAE published

Exelixis reports updated interim data from trials of XL765 small molecule inhibitor of PI3K and mTOR

Microplasmin exhibits potential to cure 50% of patients with macular hole

Celgene reports initial data from investigator-initiated study of REVLIMID

Researchers present clinical outcomes of lenalidomide in patients with large B-cell lymphoma

Antiemetic-regimen with fosaprepitant injection provides similar protection against CINV as oral EMEND

Promising results of ABRAXANE for bladder cancer support efficacy of nab-driven chemotherapy

Alimera Sciences provides new data from Iluvien Phase 3 FAME clinical trials for DME

CSL Behring granted authorization to market Berinert for HAE in Italy and Luxembourg

POZEN receives milestone payment from AstraZeneca for FDA approval of VIMOVO

Genzyme's Lumizyme for Pompe disease receives FDA marketing approval

Bayer's Adalat XL product and Mylan's nifedipine extended release 60 mg not bioequivalent: Study

Salix Pharmaceuticals announces availability of Xifaxan tablets for reducing risk of overt HE recurrence

Data evaluating use of nab-paclitaxel for treatment of pancreatic cancer to be presented at ASCO 2010

New data highlighting Pfizer's approach to cancer drug development to be presented at ASCO meeting

Provectus to present further positive data from PV-10 Phase 2 clinical trial for metastatic melanoma at ASCO

FDA approves ZYMAXID ophthalmic solution for treatment of bacterial conjunctivitis

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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