Peripheral Edema News and Research

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Pfizer’s Lyrica Phase 3 study on pDPN fails to meet primary endpoint

Pfizer Inc. announced today that a Phase 3 randomized withdrawal design study for Lyrica (pregabalin) in patients with inadequately treated painful diabetic peripheral neuropathy (pDPN) did not meet its primary efficacy endpoint, change in endpoint mean pain score relative to baseline.

5 May 2012

Micromet receives FDA feedback on blinatumomab registration for R/R ALL

Micromet, Inc. today outlined a clinical development plan intended to support U.S. registration of its lead product candidate blinatumomab in patients with B-precursor relapsed/refractory (r/r) acute lymphoblastic leukemia.

14 Oct 2011

Blinatumomab phase 2 trial results on acute lymphoblastic leukemia to be presented at EHA 2011

Data to be presented tomorrow at the 16th Annual Meeting of the European Hematology Association (EHA) in London, UK, show that Micromet's blinatumomab produced a high complete remission rate in adult patients with acute lymphoblastic leukemia (ALL) who had relapsed following treatment with standard therapy.

10 Jun 2011

Combination therapy may reduce albuminuria in patients with type 2 diabetes: Study

Results from a Phase 2, 8-week dose-ranging study using low doses of atrasentan in patients with diabetic kidney disease were published this week in the Journal of the American Society of Nephrology. The published study results suggest that atrasentan, used in conjunction with renin-angiotensin system inhibitors, may reduce albuminuria (presence of protein in urine) for patients with type 2 diabetes.

5 Mar 2011

Combination therapy initially, best for blood pressure control: ACCELERATE study

A new study published online Jan. 13 in The Lancet shows that patients with high blood pressure respond better to a combination drug therapy than those on monotherapy. Also patients who undergo the two-drug treatment after taking the single-drug therapy also experience better blood pressure outcomes, though not at the same level as those who began with the combination treatment, according to research.

13 Jan 2011

Study: REVLIMID and dexamethasone for high-risk smoldering multiple myeloma reduce risk of disease progression

Celgene International Sàrl (NASDAQ: CELG) announced that data evaluating combination therapy REVLIMID® (lenalidomide) and dexamethasone in patients with high-risk asymptomatic smoldering multiple myeloma were presented during the American Society of Hematology's annual meeting. The study reported REVLIMID and dexamethasone prolonged time to progression.

6 Dec 2010

Acceleron presents ACE-041 interim results for advanced cancer at EORTC-NCI-AACR Symposium

Acceleron Pharma, Inc., a biopharmaceutical company developing novel protein therapeutics that regulate the growth and development of tissues and cells, including muscle, bone, red blood cells, and vasculature, today announced the presentation of interim results from the first-in-human clinical study of ACE-041 in patients with advanced cancer at the 22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Berlin, Germany.

20 Nov 2010

Essentialis receives patent for active component in DCCR product

Essentialis, Inc. announced today that the United States Patent & Trademark Office (USPTO) has issued U.S. Patent No. 7,799,777 entitled Salts of potassium ATP channel openers and uses thereof. The patent claims a novel composition of a polymorph of diazoxide choline, the active ingredient in the Essentialis lead product, DCCR. Essentialis has successfully completed phase 2b clinical trials with DCCR, showing a highly significant triglyceride reduction in dyslipidemic patients.

12 Oct 2010

Seattle Genetics reports SGN-75 phase I clinical trial data

Seattle Genetics, Inc. today reported data from a phase I clinical trial of SGN-75 in patients with non-Hodgkin lymphoma or renal cell carcinoma (RCC). Preliminary results demonstrate tolerability and antitumor activity, including two objective responses in the first 16 patients treated. Dose-escalation is continuing.

11 Oct 2010

BioCryst reports results from forodesine studies for CTCL and CLL

BioCryst Pharmaceuticals, Inc. announced preliminary top-line results from its multinational, open-label, single-arm trial evaluating 200 mg once-daily oral forodesine in the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL), as well as interim results from the Company's exploratory Phase 2 study to investigate the efficacy and safety of 200 mg twice-daily oral forodesine as monotherapy for chronic lymphocytic leukemia (CLL).

15 Sep 2010

Genmab reports top-line interim results from ofatumumab Phase II study in Diffuse Large B-Cell Lymphoma

Genmab A/S announced today top-line interim results from an initial Phase II single arm open label study of ofatumumab to evaluate the treatment of relapsed Diffuse Large B-Cell Lymphoma in patients ineligible for or relapsed following a stem cell transplant.

11 Aug 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

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

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

Regeneron Pharmaceuticals provides update on REGN727, REGN475 antibody product candidates

Regeneron Pharmaceuticals, Inc. (REGN) provided an update on two antibody product candidates in its pipeline and scheduled its first Investor Day to be held in New York City on July 15, 2010. Both product candidates, REGN727 (SAR236553) and, REGN475 (SAR164877) are being developed with sanofi-aventis under a global, strategic collaboration to discover, develop, and commercialize fully human antibodies.

13 May 2010

Xifaxan drug receives FDA approval

The U.S. Food and Drug Administration today approved the use of Xifaxan for reduction in the risk of the recurrence of overt hepatic encephalopathy (HE) in patients with advanced liver disease.

25 Mar 2010

AMAG Pharmaceuticals releases safety update on Feraheme Injection

AMAG Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today provided a safety update on Feraheme® (ferumoxytol) Injection for intravenous use.

6 Feb 2010

3Sbio submits registrational clinical trial application for Feraheme injection

3SBio Inc., a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a registrational clinical trial to the Chinese State Food and Drug Administration ("SFDA") for Feraheme (ferumoxytol) Injection for intravenous use.

8 Jan 2010

Phase 2 pivotal trial of AC220 initiated by Ambit Biosciences

Ambit Biosciences Corporation announced today the enrollment and dosing at the University of Texas M. D. Anderson Cancer Center of the first patient in the ACE (AC220 Monotherapy Efficacy) Phase 2 pivotal trial in patients with relapsed or refractory acute myeloid leukemia (AML).

11 Dec 2009

FDA grants marketing approval for Elitek

Sanofi-aventis U.S. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Elitek (rasburicase) to be used for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid.

19 Oct 2009