Heparin News and Research

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Heparin, a highly-sulfated glycosaminoglycan, is widely used as an injectable anticoagulant, and has the highest negative charge density of any known biological molecule. It can also be used to form an inner anticoagulant surface on various experimental and medical devices such as test tubes and renal dialysis machines. Pharmaceutical grade heparin is derived from mucosal tissues of slaughtered meat animals such as porcine (pig) intestine or bovine (cow) lung.

US Patent & Trademark Office allows patent application for NOD technology

NOD Pharmaceuticals Inc. announced the US Patent & Trademark Office (PTO) has allowed the patent application for its nano-particle oral delivery or NOD technology.

25 Nov 2009

Eclipsys reaches milestone: 50 millionth order entered into its EHR system

Eclipsys Corporation®, The Outcomes Company®, continues to strengthen its position as a leader in computerized physician order entry (CPOE) with the announcement today that long-standing client Sarasota Memorial Health Care System (Sarasota Memorial), located in Sarasota, FL, recently entered its 50 millionth order into its electronic health record (EHR) system. The notable physician order was entered by emergency medicine specialist Bill Colgate, MD.

23 Nov 2009

PolyMedix completes public offering of units for aggregate gross proceeds of $20.7 million

PolyMedix Inc. (http://polymedix.com), an emerging biotechnology company developing acute care therapeutic drug products for infectious diseases and cardiovascular disorders, announced today that it has completed a public offering of units for aggregate gross proceeds of $20.7 million.

18 Nov 2009

Study suggests a new improved treatment option for children with Hurler's syndrome

Researchers have transplanted genetically modified hematopoietic stem cells into mice so that their developing red blood cells produce a critical lysosomal enzyme - preventing or reducing organ and central nervous system damage from the often-fatal genetic disorder Hurler's syndrome.

10 Nov 2009

GTC Biotherapeutics announces financial results for third quarter 2009

GTC Biotherapeutics, Inc.’s total net loss for the third quarter ended September 27, 2009 was $5.1 million, or $0.48 per share, compared with $6.1 million, or $0.59 per share, in the third quarter of 2008. The total net loss for the first nine months of 2009 was $26.2 million, or $2.51 per share, compared to $16.5 million, or $1.71 per share, for the first nine months of 2008.

6 Nov 2009

Fresenius Medical Care reports financial results for the third quarter and first nine months of 2009

Fresenius Medical Care AG & Co. KGaA, the world’s largest provider of dialysis products and services, today announced its results for the third quarter and first nine months of 2009.

3 Nov 2009

sanofi-aventis reports financial results for the third quarter of 2009

In the third quarter of 2009, sanofi-aventis generated net sales of euro 7,400 million, up 8.0% on a reported basis. Exchange rate movements had a favorable effect of 2.0 percentage points, with the appreciation of the U.S. dollar (and to a lesser extent the yen) against the euro more than offsetting the unfavorable effects of some other currencies.

30 Oct 2009

PolyMedix completes second successful clinical study of PMX-60056

PolyMedix, Inc. (http://polymedix.com), an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders, has completed a second successful clinical study of its anticoagulant reversing agent, PMX-60056.

27 Oct 2009

CHMP grants positive opinion to extend the use of Angiox to patients undergoing PCI

The Medicines Company announced today that the Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion applicable to all Member States of the European Union/European Economic Area that will extend the use of Angiox (bivalirudin) to include patients with heart attacks (so-called ST segment elevation myocardial infarction (STEMI)) undergoing emergency heart procedures called primary percutaneous coronary intervention (PCI).

24 Oct 2009

U.S. Pharmacopeial fellowships awarded to 6 students

New research focused on the quality of key medicines and their use as well as increasingly popular botanicals is being sponsored by the U.S. Pharmacopeial (USP) Convention under its 2009� Fellowship Program.

21 Oct 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

Contaminated pre-filled heparin and saline syringes cause bloodstream infections

An outbreak of bloodstream infections appears to have been caused by the contamination of pre-filled heparin and saline syringes made by a single company, according to a report in the October 12 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. The subsequent investigation revealed that the company was not in compliance with safety regulations and identified challenges and areas for improvement in medication monitoring systems.

13 Oct 2009

Second round of revised quality standards for blood thinner heparin released

Further helping to secure public health, a second round of revised quality standards for the widely used blood thinner heparin became effective today, the U.S. Pharmacopeial (USP) Convention announced. Working closely with the Food and Drug Administration (FDA), the pharmaceutical industry, and other regulatory and scientific bodies, USP started initial revisions in 2008 after adverse reactions and deaths resulted from heparin intentionally adulterated with over-sulfated chondroitin sulfate (OSCS).

5 Oct 2009

$APP Pharmaceutical continues support of FDA's USP standards for unfractionated heparin$

APP Pharmaceutical continues support of FDA's USP standards for unfractionated heparin

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ), and the leading supplier of heparin sodium to the U.S. market, announced today its continued support of the US Food & Drug Administration (FDA) and medical community for the October 1, 2009 implementation of the new United States Pharmacopeia (USP) monograph change for unfractionated heparin.

3 Oct 2009

Change in Heparin manufacturing - expected to decrease the potency

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

1 Oct 2009

Polymedix commences Phase 1B study of novel anticoagulant reversing agent

PolyMedix, Inc., an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders based on biomimetics, has initiated dosing and commenced a second clinical trial, a Phase 1B pilot proof of concept study, in the U.S. with its anticoagulant reversing agent PMX-60056 under an Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration (FDA).

30 Sep 2009

Heparin-induced skin lesions may indicate platelets deficit

Heparin, a commonly used anticoagulant, can cause skin lesions, reports a study http://www.cmaj.ca/press/cmaj081729.pdf in CMAJ (Canadian Medical Association Journal) www.cmaj.ca.

29 Sep 2009

First heart surgery using MECC system completed

MAQUET Cardiovascular announced today that Johannes Bonatti, M.D., Professor of Surgery and Director of Coronary Surgery and Advanced Coronary Interventions at the University of Maryland Heart Center in Baltimore, has completed the world's first use of the MAQUET Minimized ExtraCorporeal Circulation (MECC) system during a successful robotic and fully endoscopic heart surgery. The new cardiopulmonary bypass technology is the first major advancement in perfusion technology in the last decade. It is designed to minimize the effects of traditional heart surgery and aid in minimally-invasive heart surgery without the need to stop the patient's heart from beating.

28 Sep 2009

HORIZONS-AMI clinical trial demonstrates efficacy of drug-eluting stent

Late-breaking data from the landmark HORIZONS-AMI clinical trial, presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, demonstrated that after two years, in heart attack patients, the use of a drug-eluting stent (paclitaxel) was safer and more effective than a bare-metal stent; and that the administration of the anticoagulant medication bivalirudin enhanced safety and efficacy compared to the use of heparin + GPIIb/IIIa inhibitors.

25 Sep 2009

Researchers to present results of HORIZONS-AMI trial at TCT scientific symposium

Two subset analyses from the landmark HORIZONS-AMI trial show that the anticoagulant bivalirudin lowers major bleeding and cardiac death versus the combination of heparin and a GP IIb/IIIa inhibitor in patients with ST-segment myocardial infarction (STEMI) who have disease of the left anterior descending artery (LAD), while in STEMI patients at highest risk for death, bivalirudin also confers the greatest mortality benefit.

22 Sep 2009