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Jury returns $7M verdict for failure to diagnose and treat cardiac tamponade in bypass surgery patient

A New York State Supreme Court Queens County jury returned a $7,000,000.00 verdict against Patrick Monteleone M.D. and Newell Robinson, M.D. where they failed to diagnose and treat cardiac tamponade (bleeding into the chest) in their patient who underwent cardiac bypass surgery on November 17, 2004.

23 Dec 2010

FDA approves Watson's novel oral contraceptive

Watson Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) approval of a novel oral contraceptive product – the first and only low dose oral contraceptive to combine 0.8 mg norethindrone and 0.025 mg ethinyl estradiol in chewable form, with four 75 mg ferrous fumarate (iron) placebo tablets. Taken orally, once daily, the product is proven effective in lowering the risk of pregnancy.

22 Dec 2010

New era for anticoagulant therapy

In a Guest Editorial published in the new publication Clinical Investigation, Dr Jeffrey Weitz and Dr John Eikelboom of McMaster University in Hamilton, Canada highlight the importance of the approval in October by the FDA of dabigatran etexilate (Pradaxa®; Boehringer Ingelheim). This new oral thrombin inhibitor provides an alternative to warfarin for long-term stroke prevention in patients with non-valvular atrial fibrillation.

22 Dec 2010

Top ten advances in cardiovascular, stroke research in 2010

Research on reducing risks, improving medical treatment and improving lifestyle behaviors to fight the battle against heart disease and stroke are among the key scientific findings that make up this year's top cardiovascular and stroke research recognized by the American Heart Association/American Stroke Association.

22 Dec 2010

LFB receives positive review feedback for closing of Willfact 1000 IU Mutual Recognition Procedure

LFB received from the German regulatory authority (Paul-Ehrlich-Institute) a positive review feedback for the closing of the Mutual Recognition Procedure (MRP) of Willfact® 1000 IU with Germany as the reference member state.

22 Dec 2010

Arrow announces worldwide voluntary recall of 5800 Series IABs with Super Arrow-Flex Sheath Introducer

Arrow International has announced a worldwide voluntary recall of its 5800 Series IABs with Super Arrow-Flex Sheath Introducer. This recall is being conducted because of an increase of "stuck in sheath" reports involving the use of the Super Arrow-Flex Sheath with 5800 Series IAB products. When the IAB becomes stuck in sheath, the user is unable to move the IAB catheter forward or backward, potentially causing a delay in critical therapy.

22 Dec 2010

FDA approves Medtronic Endurant AAA Stent Graft System for abdominal aortic aneurysms

An estimated 1.2 million people in the United States have an abdominal aortic aneurysm (AAA) - a dangerous bulge or ballooning in their bodies' main artery that typically causes no symptoms until it ruptures, which can be deadly - and most of them don't know it. But for those with a known AAA of a certain size, there's a new medical device for a safe and effective treatment option that doesn't require major surgery, an extended hospital stay and a long recovery period.

21 Dec 2010

Halt Medical presents results of Halt Fibroid Study at NIH Global Fibroid Congress

Women suffering from uterine fibroids, a debilitating condition that affects more than seven million women in the U.S., may soon have reason for hope. Halt Medical, a biomedical company based in the San Francisco Bay Area, is developing a minimally invasive procedure for treating the condition. The company recently presented their findings from studies in Latin America at the NIH Global Fibroid Congress.

21 Dec 2010

DMN: Lax supervision of residents at U.S. teaching hospitals puts patients at risk

The Dallas Morning News investigates issues of patients safety in the wake of sweeping efforts to reform the health system.

20 Dec 2010

FDA warns against consumption of Sally Jackson cheese due to risk of E. coli O157:H7

The FDA, in cooperation with other state and local public health agencies, is warning consumers not to eat any Sally Jackson cheeses. The products were processed under conditions that create a significant risk of contamination of the unpasteurized raw milk and finished cheese, and Sally Jackson cheeses have been identified as one possible source of eight cases of E. coli O157 infections in an ongoing investigation.

20 Dec 2010

FDA moves to curb Avastin's approval for breast cancer

The Food and Drug administration on Thursday revoked its approval of Roche drug Avastin for the treatment of breast cancer. The agency's action, based on findings that did not confirm that the medicine helped patients with this disease, has drawn criticism from patients and politicians.

20 Dec 2010

Catalyst receives $4.0M milestone payment from Pfizer under hemophilia Factor VIIa program

Catalyst Biosciences, Inc., the leading company in the discovery and development of engineered proteases, today announced the receipt of a $4.0 million milestone payment from Pfizer Inc. under the terms of the collaboration agreement for the development of improved recombinant human Factor VIIa variants for the treatment of hemophilia and other bleeding disorders.

17 Dec 2010

Repros prepares for dosing 3 mg cohort in low dose Proellex study in uterine fibroids and endometriosis

Repros Therapeutics Inc. today announced it has commenced preparation for dosing the 3 mg cohort in the Company's low dose study of Proellex® following a safety review of data from women that have completed 8 weeks of treatment at a 1 mg dose. No signals of liver toxicity were detected to date in the 1 mg group. Unexpectedly, low levels of drug activity were detected in this first cohort. The Company plans to commence dosing of the second group, 3 mg Proellex, next week.

17 Dec 2010

FDA recommends removal of breast cancer indication from Avastin label

The U.S. Food and Drug Administration announced today that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

17 Dec 2010

Watson, PregLem enter licensing agreement to develop, market Esmya in the U.S. and Canada

Watson Pharmaceuticals, Inc. and Gedeon Richter Plc today announced that Watson's subsidiary, Watson Laboratories, Inc. has entered into an exclusive licensing agreement with PregLem, S.A., ("Preglem") the wholly owned subsidiary of Richter, to develop and market Esmya™ (ulipristal acetate) in the U.S. and Canada.

16 Dec 2010

Ultrasound-based diagnosis for rapid detection of benign and malignant ovarian cancer

It is crucial to differentiate between benign and malignant ovarian cysts and tumours in a fast and reliable manner. This improves the surgical management and prognosis of the patient.

16 Dec 2010

Positive results from large, multi-center Canadian trial with On-X Prosthetic Heart Valve

On-X® Life Technologies, Inc., today announced the publication of results of a large, prospective multi-center Canadian trial with the On-X® Prosthetic Heart Valve in the November issue of The Journal of Thoracic and Cardiovascular Surgery.1 According to the results of the report, "The On-X mechanical prosthesis provides favorable intermediate-term results with regard to major thromboembolism, hemorrhage and composites of valve-related complications."

15 Dec 2010

Bleeding News and Research

Jury returns $7M verdict for failure to diagnose and treat cardiac tamponade in bypass surgery patient

FDA approves Watson's novel oral contraceptive

New era for anticoagulant therapy

Top ten advances in cardiovascular, stroke research in 2010

LFB receives positive review feedback for closing of Willfact 1000 IU Mutual Recognition Procedure

Arrow announces worldwide voluntary recall of 5800 Series IABs with Super Arrow-Flex Sheath Introducer

FDA approves Medtronic Endurant AAA Stent Graft System for abdominal aortic aneurysms

Halt Medical presents results of Halt Fibroid Study at NIH Global Fibroid Congress

DMN: Lax supervision of residents at U.S. teaching hospitals puts patients at risk

FDA warns against consumption of Sally Jackson cheese due to risk of E. coli O157:H7

FDA moves to curb Avastin's approval for breast cancer

Catalyst receives $4.0M milestone payment from Pfizer under hemophilia Factor VIIa program

Repros prepares for dosing 3 mg cohort in low dose Proellex study in uterine fibroids and endometriosis

FDA recommends removal of breast cancer indication from Avastin label

Watson, PregLem enter licensing agreement to develop, market Esmya in the U.S. and Canada

Ultrasound-based diagnosis for rapid detection of benign and malignant ovarian cancer

Positive results from large, multi-center Canadian trial with On-X Prosthetic Heart Valve

National Institutes of Health honors Nevada nursing professor with $377,000 for ischemia study

Researchers examine outcomes related to antiplatelet therapy in patients undergoing CEA

Warfarin may not be beneficial to some patients with atrial fibrillation: Researchers

Revolutionizing Life Science: An Interview with SCIEX on ASMS, the SCIEX 7500+ System, and AI-Driven Quantitation

From Discovery Biology to ELRIG Chair

Breathing New Life into Diagnostics: Plasmion's SICRIT Technology

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