Hypotension News and Research

RSS

Otsuka announces results from aripiprazole Phase 3 trial on schizophrenia

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S today announced results from a Phase 3 clinical trial evaluating the efficacy, safety and tolerability of once-monthly aripiprazole intramuscular (IM) depot formulation for the maintenance treatment of adults with schizophrenia.

8 May 2012

Positive results from Dainippon Sumitomo Pharma's LATUDA trials for bipolar I depression

Dainippon Sumitomo Pharma Co., Ltd. announced today results from two Phase 3 clinical trials designed to evaluate the efficacy and safety of LATUDA as adjunctive therapy and monotherapy, respectively, in patients with bipolar I depression (PREVAIL 1 and PREVAIL 2; PRogram to EValuate the Antidepressant Impact of Lurasidone).

7 May 2012

CSI third quarter revenues increase 5% to $21.2 million

Cardiovascular Systems, Inc. (CSI), a medical device company developing and commercializing innovative interventional treatment systems for vascular disease, today reported financial results for its fiscal third quarter ended March 31, 2012.

3 May 2012

BTG launches Voraxaze for treatment of toxic plasma methotrexate

BTG International Inc., the specialist healthcare company today announces the launch of Voraxaze (glucarpidase) in the US. Voraxaze is indicated for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function.

30 Apr 2012

EMA CHMP recommends approval of AMAG’s ferumoxytol

AMAG Pharmaceuticals, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the approval of ferumoxytol, an intravenous (IV) iron therapy, for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease.

21 Apr 2012

Abbott reports positive results from LCIG Phase 3 trial for advanced Parkinson's disease

Abbott announced today the results from a Phase 3 trial evaluating the company's investigational compound for advanced Parkinson's disease, levodopa-carbidopa intestinal gel (LCIG).

18 Apr 2012

UCB receives FDA approval for Neupro to treat idiopathic Parkinson's, RLS

UCB announced today that the U.S. Food and Drug Administration (FDA) approved Neupro (Rotigotine Transdermal System) for the treatment of the signs and symptoms of advanced stage idiopathic Parkinson's disease (PD) and as a treatment for moderate-to-severe primary Restless Legs Syndrome.

3 Apr 2012

Better evidence for effectiveness of drug-based approaches for relieving labour pains

There is better evidence for the effectiveness of drug-based approaches for relieving labour pains than non-drug approaches. These are the findings of an all-encompassing publishing in The Cochrane Library, which draws together results from a number of previous reviews on the subject.

15 Mar 2012

FDA denies AstraZeneca Citizen Petitions on SEROQUEL labeling

AstraZeneca today announced that on March 7, 2012, the Food and Drug Administration denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labeling that omits certain hyperglycemia warning language that the FDA required AstraZeneca to include in the labeling for SEROQUEL (quetiapine fumarate) tablets and SEROQUEL XR (quetiapine fumarate) extended-release tablets.

12 Mar 2012

AMAG fourth quarter total revenues decrease to $14.9 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, 2011. As of December 31, 2011, the company's cash, cash equivalents and investments totaled approximately $230 million.

5 Mar 2012

U.S. FDA accepts Pfizer's tafamidis NDA for treatment of TTR-FAP

Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tafamidis meglumine, the company's investigational, novel, oral therapy for the treatment of Transthyretin Familial Amyloid Polyneuropathy.

16 Feb 2012

Valeant receives FDA approval for secondary supplier of Methoxsalen

The FDA has approved the addition of a secondary supplier of Methoxsalen USP, an integral component of a treatment for the relief of moderate to severe psoriasis prescribed under the brand name Oxsoralen-Ultra (methoxsalen) Capsules, USP, 10mg.

15 Feb 2012

Genzyme announces four-year data from eliglustat tartrate phase 2 trial on Gaucher disease type 1

Genzyme, a Sanofi company, announced today four-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.

8 Feb 2012

Takeda launches EDARBYCLOR in the U.S. for treatment of hypertension

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., announced EDARBYCLOR (azilsartan medoxomil and chlorthalidone) is now available by prescription in U.S. pharmacies for the treatment of hypertension to lower blood pressure in adults.

6 Feb 2012

AMAG completes enrollment in Feraheme Phase III program for iron-deficiency anemia

AMAG Pharmaceuticals, Inc. today announced the completion of patient enrollment in the second of the company's two phase III studies that comprise its global registrational program for Feraheme (ferumoxytol) in patients with iron-deficiency anemia (IDA) who are not candidates for oral iron, regardless of the underlying cause.

30 Jan 2012

Voraxaze receives FDA approval for treatment of toxic methotrexate levels

The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.

18 Jan 2012

UCB initiates EXXELERATE study in rheumatoid arthritis

UCB today announced the start of the EXXELERATE study which will evaluate the short- and long-term efficacy of Cimzia (certolizumab pegol) plus methotrexate (MTX) compared with that of Humira(adalimumab) plus MTX in the treatment of moderate to severe rheumatoid arthritis (RA). The start of this study confirms previously announced plans.

21 Dec 2011

Takeda receives FDA approval for EDARBYCLOR to treat hypertension

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced that the U.S. Food and Drug Administration (FDA) approved EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the treatment of hypertension to lower blood pressure in adults.

21 Dec 2011

CDER, Shire enter agreement for ProAmatine clinical trial to treat symptomatic orthostatic hypotension

Shire plc, the global specialty biopharmaceutical company, announces that it has reached an agreement with the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration to conduct additional clinical trials to confirm the clinical benefit of ProAmatine (midodrine HCl), a medicine approved in 1996 under Subpart H for the treatment of symptomatic orthostatic hypotension (SOH).

3 Dec 2011

Study reveals classification scheme for treatment of blunt aortic injury

New research at the University of Washington's (UW) Harborview Medical Center in Seattle reveals a classification scheme for the treatment of blunt aortic injury.

1 Dec 2011