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 approves longer Valcyte therapy for CMV disease in adult kidney transplant patients

Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.

11 Aug 2010

Isis second-quarter pro forma net operating loss increases to $15.5 million

Isis Pharmaceuticals, Inc. today announced its financial results for the quarter ended June 30, 2010. The Company finished the second quarter of 2010 with a pro forma net operating loss (NOL) of $15.5 million and $17.1 million for the three and six months ended June 30, 2010, respectively, compared to a pro forma net operating loss of $1.3 million and pro forma net operating income of $798,000 for the same periods of 2009.

9 Aug 2010

FDA accepts Salix's XIFAXAN550 sNDA for Priority Review

Salix Pharmaceuticals, Ltd. today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Company's efficacy supplement to the New Drug Application (NDA) for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating.

9 Aug 2010

Dyax announces first Phase 3 trial results of KALBITOR for acute HAE

Dyax Corp. announced today that results from EDEMA3, the Company's first Phase 3 trial evaluating KALBITOR (ecallantide) for the treatment of acute attacks of hereditary angioedema, were published in the August issue of The New England Journal of Medicine. KALBITOR, discovered and developed by Dyax, is available in the United States for the treatment of acute attacks of HAE in patients 16 years of age and older.

6 Aug 2010

Sanofi-aventis receives FDA approval for new Taxotere Injection Concentrate formulation

Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) has approved a new one-vial formulation of its chemotherapeutic agent Taxotere® (docetaxel) Injection Concentrate. The 1-vial Taxotere is anticipated to become available to cancer treatment clinics and hospitals nationwide in the fall in both 80 mg and 20 mg dosages.

5 Aug 2010

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

Allergan second-quarter diluted EPS increases to $0.78

Allergan, Inc. today announced operating results for the quarter ended June 30, 2010. Allergan also announced that its Board of Directors has declared a second quarter dividend of $0.05 per share, payable on September 7, 2010 to stockholders of record on August 17, 2010.

3 Aug 2010

Cardioxyl Pharmaceuticals achieves positive results in first clinical study of CXL-1020 for ADHF

Cardioxyl Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel therapeutic agents for the treatment of cardiovascular disease, today announced that it has achieved positive safety and tolerability results in the first clinical study of its lead drug candidate, CXL-1020, for the treatment of patients with acute decompensated heart failure. Each year in the United States, more than one million patients are hospitalized with acute heart failure.

2 Aug 2010

Xeomin receives FDA approval for treatment of cervical dystonia

Merz Pharmaceuticals today announced that the United States Food and Drug Administration has approved Xeomin (incobotulinumtoxinA), a botulinum toxin type A for the treatment of adults with cervical dystonia or blepharospasm. According to an epidemiology study conducted in Rochester, Minnesota, the prevalence of focal dystonia, which includes cervical dystonia and blepharospasm, is estimated at 295 per million people in the U.S.

2 Aug 2010

New findings on snake venom toxin hold promise for developing heart disease, cancer therapies

Researchers seeking to learn more about stroke by studying how the body responds to toxins in snake venom are this week releasing new findings that they hope will aid in the development of therapies for heart disease and, surprisingly, cancer. The Japanese team is reporting in a Journal of Biological Chemistry "Paper of the Week" that they are optimistic that inhibiting a protein found on the surface of blood cells known as platelets may combat both irregular blood clotting and the spread of certain cancers throughout the body.

30 Jul 2010

New Zealand MEDSAFE approves ABRAXANE for metastatic breast cancer

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, and Specialised Therapeutics Ltd. today announced that MEDSAFE, the New Zealand Medicines and Medical Devices Safety Authority, has approved for marketing ABRAXANE® (nanoparticle albumin-bound paclitaxel) for the treatment of metastatic breast cancer after failure of anthracycline therapy.

29 Jul 2010

Dyax second-quarter total revenues increase to $15.1 million

Dyax Corp. today announced financial results for the second quarter ended June 30, 2010.

28 Jul 2010

Regeneron second-quarter total revenues increase to $115.9 million

Regeneron Pharmaceuticals, Inc. announced financial and operating results for the second quarter of 2010. The Company reported a net loss of $25.5 million, or $0.31 per share (basic and diluted), for the second quarter of 2010 compared with a net loss of $14.9 million, or $0.19 per share (basic and diluted), for the second quarter of 2009.

28 Jul 2010

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus infection to peginterferon alpha-based therapy.

28 Jul 2010

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, today announced that Taiho Pharmaceutical Co., Ltd. has received approval from the Ministry of Health, Labor and Welfare to market ABRAXANE IV Infusion 100 mg, Paclitaxel Injection (Suspension with Albumin), for use in the treatment of breast cancer. The New Drug Application (J-NDA) for ABRAXANE was filed with the Ministry of Health, Labor and Welfare in 2008.

23 Jul 2010

Ampio Pharmaceuticals commences Optina Phase II clinical trial for diabetic macular edema

Ampio Pharmaceuticals, Inc. today announced the initiation of a Phase II clinical trial of Optina™ for the treatment of diabetic macular edema, an early stage of diabetic retinopathy. Diabetic macular edema is responsible for most vision loss in patients with diabetes mellitus.

22 Jul 2010

California companies are developing new medicines for diabetes: Report

Pharmaceutical research and biotechnology companies based in California are researching and developing 58 new medicines for diabetes, a chronic disease that afflicts 220 million patients worldwide, including 23.6 million Americans, a new report shows.

21 Jul 2010

Dyax launches newly enhanced product website featuring comprehensive financial assistance program

Dyax Corp. today announced that it has launched its newly enhanced product website, www.KALBITOR.com, featuring its comprehensive financial assistance program. KALBITOR (ecallantide) is approved for the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.

20 Jul 2010

Phase 3 study: Tapentadol ER lowers incidence of gastrointestinal adverse events

A Phase 3 open-label study, recently published online by Pain Practice, has compared tapentadol extended release tablets, an investigational pain medication, to an existing prescription pain medication, oxycodone controlled release tablets.

20 Jul 2010

First-of-its-kind patient, healthcare provider support program for management of HE

Concentric Pharma Advertising, an independent healthcare advertising and marketing agency, announces the creation of Salix Pharmaceuticals' Hepatic Encephalopathy Living Program. H.E.L.P. launched May 24, 2010, and coincides with the launch of Xifaxan550 (rifaximin) for the management of patients 18 or older at risk for overt hepatic encephalopathy recurrence.

16 Jul 2010

Edema News and Research

Further Reading

FDA approves longer Valcyte therapy for CMV disease in adult kidney transplant patients

Isis second-quarter pro forma net operating loss increases to $15.5 million

FDA accepts Salix's XIFAXAN550 sNDA for Priority Review

Dyax announces first Phase 3 trial results of KALBITOR for acute HAE

Sanofi-aventis receives FDA approval for new Taxotere Injection Concentrate formulation

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Allergan second-quarter diluted EPS increases to $0.78

Cardioxyl Pharmaceuticals achieves positive results in first clinical study of CXL-1020 for ADHF

Xeomin receives FDA approval for treatment of cervical dystonia

New findings on snake venom toxin hold promise for developing heart disease, cancer therapies

New Zealand MEDSAFE approves ABRAXANE for metastatic breast cancer

Dyax second-quarter total revenues increase to $15.1 million

Regeneron second-quarter total revenues increase to $115.9 million

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

Ampio Pharmaceuticals commences Optina Phase II clinical trial for diabetic macular edema

California companies are developing new medicines for diabetes: Report

Dyax launches newly enhanced product website featuring comprehensive financial assistance program

Phase 3 study: Tapentadol ER lowers incidence of gastrointestinal adverse events

First-of-its-kind patient, healthcare provider support program for management of HE

Achieving and maintaining ISO/IEC 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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