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Cardioxyl's CXL-1020 preclinical data against heart failure presented at ACC meeting

Cardioxyl Pharmaceuticals, Inc. announced today that it is presenting two abstracts from studies of its lead clinical candidate, CXL-1020, at the American College of Cardiology's 60th Annual Scientific Session & Expo in New Orleans, Louisiana.

5 Apr 2011

Abiomed presents Impella PROTECT II study final results in PCI at ACC and i2 Summit

Abiomed, Inc., a leading provider of breakthrough heart support technologies, today announced the final results from the PROTECT II study, presented by William O'Neill, M.D., Dean of University of Miami and Principal Investigator of PROTECT II, at the American College of Cardiology's 60th Annual Scientific Session and i2 Summit 2011 in New Orleans.

4 Apr 2011

Merck's VICTRELIS phase III study results against HCV presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced results from several new data analyses from the pivotal Phase III studies evaluating the addition of its investigational oral protease inhibitor VICTRELIS to peginterferon alfa-2b and ribavirin in adult patients with chronic hepatitis C virus genotype 1 infection.

1 Apr 2011

Watson, GeneraMedix receive FDA approval for Nulecit to treat iron deficiency anemia

Watson Pharmaceuticals, Inc. today announced that it is initiating launch activities of Nulecit, following FDA approval of GeneraMedix Inc.'s, Abbreviated New Drug Application.

1 Apr 2011

PHOENIX phase III trial of PHP for distributive shock to continue after positive midpoint recommendation from DMB

The PHOENIX trial is a European, placebo-controlled, Phase III study treating catecholamine-resistant patients in distributive shock with the Nitric Oxide (NO) scavenger Pyridoxalated Haemoglobin Polyoxyethylene Conjugate (PHP). The study was launched by Curacyte AG in Austria, Belgium, Germany, Spain, The Netherlands and in the United Kingdom in 2009.

28 Mar 2011

BMY receives FDA approval for YERVOY to treat metastatic melanoma

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration approved YERVOY 3 mg/kg for the treatment of patients with unresectable or metastatic melanoma.

28 Mar 2011

FDA grants CSI marketing clearance for Stealth 360° Orbital PAD System

Cardiovascular Systems, Inc. has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA), and has begun a limited market release for the Stealth 360°™ Orbital PAD System. The Stealth 360° propels CSI into the forefront of treating peripheral arterial disease (PAD) with a simpler design that gives physicians complete control of device operation.

17 Mar 2011

Chelsea uses PHT's LogPad, SitePad Tablet for clinical study to treat Parkinson's patients with NOH

PHT Corporation announced that Chelsea Therapeutics is using PHT's LogPad System and SitePad Tablet for its ongoing clinical study in Parkinson's disease patients with symptomatic neurogenic orthostatic hypotension.

15 Mar 2011

FDA approves BENLYSTA for active, autoantibody-positive systemic lupus erythematosus

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced that the U.S. Food and Drug Administration has approved BENLYSTA® (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.

10 Mar 2011

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced that several new data analyses from Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver annual meeting.

9 Mar 2011

Fresenius Medical Care announces acquisition of Hema Metrics assets related to Crit-Line system

Fresenius Medical Care AG & Co. KGaA, the world's largest provider of dialysis products and services, today announced the acquisition of all assets of Hema Metrics LLC related to its Crit-Line system.

8 Mar 2011

Takeda receives FDA approval for EDARBI to treat hypertension in adults

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration approved EDARBI for the treatment of hypertension, or high blood pressure, in adults.

27 Feb 2011

AMAG fourth quarter total revenues increase to $17.2 million

AMAG Pharmaceuticals, Inc. a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2010.

25 Feb 2011

Genzyme reports 3-year follow-up data from eliglustat tartrate Phase 2 trial for Gaucher disease

Genzyme Corporation today announced three-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate. Sustained or further improvements were observed across all endpoints, including bone disease, at the three-year timepoint.

19 Feb 2011

Chelsea prices underwritten public offering of 8.75 million shares of common stock

Chelsea Therapeutics International, Ltd. announced today that it has priced a public offering of 8.75 million shares of its common stock at a price of $4.00 per share which will result in gross proceeds of $35 million.

18 Feb 2011

AMAG receives Health Canada Notice of Non-Compliance for Feraheme NDS

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it has received a Notice of Non-Compliance (NON) from Health Canada regarding its New Drug Submission (NDS) for Feraheme® (ferumoxytol) injection for intravenous (IV) use for the treatment of iron deficiency anemia in adult chronic kidney disease patients.

9 Feb 2011

Phase II results of VELCADE in patients with aggressive lymphoma published in Journal of Clinical Oncology

Millennium: The Takeda Oncology Company today announced that Phase II results of a clinical trial examining VELCADE (bortezomib) in patients with previously untreated aggressive lymphoma were published in the Journal of Clinical Oncology.

5 Feb 2011

Phase III study shows tapentadol ER relieves chronic pain associated with DPN

New research has been published indicating that patients suffering from a painful complication of diabetes may experience a significant improvement in their pain as measured by a pain intensity scale when using an investigational pain medication.

29 Jan 2011

Triad alcohol prep pads with ARIXTRA Starter Kits not to be used

GlaxoSmithKline (GSK) has become aware of a United States market recall of all lots of alcohol prep pads, swabs and swabsticks manufactured by the Triad Group and marketed under various brand names. The Triad Group recall has been initiated due to concerns about potential microbial contamination of the alcohol products with Bacillus cereus that could potentially lead to life-threatening infections.

25 Jan 2011

Chelsea reports top-line data from Phase III NORTHERA extension study in NOH

Chelsea Therapeutics International, Ltd. reported new 12-month data from Study 303, a safety extension study from its Phase III NORTHERA™ (droxidopa) registration program in symptomatic neurogenic orthostatic hypotension (NOH). Preliminary, top-line results demonstrate Northera provides clinically meaningful and durable symptomatic improvements in patients with NOH throughout a one-year observation period.

20 Jan 2011