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.

BARACLUDE sNDA receives FDA approval for treatment of CHB patients with decompensated liver disease

Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of BARACLUDE for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease.

18 Oct 2010

Alimera Sciences obtains $32.5M senior secured credit facility

Alimera Sciences, Inc. announced today that it has obtained a $32.5 million senior secured credit facility to help fund its working capital requirements. The credit facility consists of a $20 million revolving line of credit provided by Silicon Valley Bank and a $12.5 million term loan provided by MidCap Financial, LLC and Silicon Valley Bank.

15 Oct 2010

FDA approves Gamunex-C for primary immunodeficiency treatment

Talecris Biotherapeutics announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI).

15 Oct 2010

Alimera to present Iluvien Phase 3 clinical trial data at AAO annual meeting

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that data from its Phase 3 (FAME) clinical trials for Iluvien will be presented this month at the annual meeting of the American Academy of Ophthalmology (AAO) in Chicago.

12 Oct 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

Ferring Pharmaceuticals announces publication of Phase 3 trials of LYSTEDA tablets for HMB

Ferring Pharmaceuticals Inc. today announced publication of one of its pivotal Phase 3 trials of LYSTEDA (tranexamic acid) tablets for cyclic heavy menstrual bleeding in the October issue of the peer-reviewed journal, Obstetrics & Gynecology. The six-month clinical trial demonstrated that LYSTEDA significantly reduced menstrual blood loss from baseline, and improved health-related quality-of-life parameters in women with cyclic HMB while maintaining safety and tolerability.

7 Oct 2010

Trekkers and climbers face high risk for Acute Mountain Sickness

Climbers of high peaks such as Mount Kilimanjaro are at high risk for Acute Mountain Sickness (AMS). Trekkers should not ignore AMS warning signs, which can progress to more serious medical outcomes.

7 Oct 2010

Nautilus Neurosciences announces exclusive co-promotion agreement for CAMBIA drug

Nautilus Neurosciences, Inc., a neurology-focused specialty pharmaceutical company, and Mission Pharmacal Company, a privately-held pharmaceutical company focused on the women's health market announced today their exclusive co-promotion agreement for CAMBIA (diclofenac potassium for oral solution) to obstetrician's, gynecologists and other women's health medical professionals.

6 Oct 2010

Hypertonic fluids do not improve outcomes or survival for severe traumatic brain injury: Study

Patients with a severe traumatic brain injury (and not in shock because of blood loss) who received out-of-hospital administration of hypertonic fluids (a solution with increased concentration of certain electrolytes and thought to help reduce intracranial pressure) as initial resuscitation did not experience better 6-month neurologic outcomes or survival compared to patients who received a normal saline solution, according to a study in the October 6 issue of JAMA.

6 Oct 2010

Xeomin botulinum toxin for cervical dystonia now available in the U.S.

Merz Pharmaceuticals today announced that Xeomin (incobotulinumtoxinA), a new botulinum toxin type A for the treatment of adults with cervical dystonia (CD)or blepharospasm, is now commercially available in the U.S. XEOMIN was approved by the U.S. Food and Drug Administration (FDA) on July 30, 2010.

6 Oct 2010

Intellect Neurosciences receives patent for Alzheimer's disease monoclonal antibody program

Intellect Neurosciences, Inc., a biopharmaceutical company with internal preclinical and clinical-stage pipelines, as well as multiple licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced that it has received a patent from the United States Patent and Trademark Office (USPTO) related to its internal Alzheimer's disease (AD) monoclonal antibody program.

5 Oct 2010

Merck to appeal against jury verdict in retrial of federal FOSAMAX case

Merck & Co., Inc. today said it will appeal a decision by the U.S. District Court for the Southern District of New York that reduced the jury verdict from $8 million to $1.5 million but denied Merck's request for judgment in its favor or a new trial in the case of Boles v. Merck, a retrial of a federal FOSAMAX case.

5 Oct 2010

J&JPRD receives FDA Complete Response Letter for tapentadol ER tablets NDA

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for tapentadol extended release tablets.

4 Oct 2010

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

Merck today announced that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, will be presented in oral plenary sessions at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place from Oct. 29 through Nov. 2 in Boston. Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting.

4 Oct 2010

Dyax, CMIC enter agreement to develop and commercialize DX-88 for HAE treatment

Dyax Corp. and CMIC Co., Ltd, announced today an agreement to develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE) and other angioedema indications in Japan.

30 Sep 2010

Ready-to-Use Cardene I.V. lowers acutely elevated blood pressure: CLUE study

Results from the CLUE study, a head-to-head comparison between Ready-to-Use Cardene I.V. (nicardipine) and labetalol in the emergency room, showed that Ready-to-Use Cardene I.V. lowers acutely elevated blood pressure more effectively than labetalol. These data were presented today at the annual meeting of the American College of Emergency Physicians (ACEP) in Las Vegas, Nevada.

29 Sep 2010

PGIC analysis indicates tapentadol ER tablets provide significant improvement in pain intensity

Phase 3 safety and efficacy data comparing tapentadol extended release (ER) tablets, an investigational pain medication, to placebo in patients with moderate to severe chronic low back pain have been published online by Expert Opinion on Pharmacotherapy. In addition, this study compared oxycodone controlled-release (CR) to placebo as an active control.

28 Sep 2010

FDA approves OZURDEX implant for uveitis treatment

Allergan, Inc. today announced that the United States Food and Drug Administration (FDA) has approved OZURDEX (dexamethasone intravitreal implant) 0.7 mg for the treatment of non-infectious ocular inflammation, or uveitis, affecting the posterior segment of the eye.

27 Sep 2010

ENTrigue partners with HemCon to distribute hemostatic surgical gel

HemCon Medical Technologies, a global innovative developer of advanced medical technologies and products, has recently partnered with ENTrigue Surgical, Inc., a leading provider of medical devices and therapies for surgeries of the Ear, Nose and Throat, to develop and distribute HemCon's latest breakthrough product, a hemostatic surgical gel.

23 Sep 2010