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Janssen submits XARELTO sNDA with FDA to reduce risk of stent thrombosis in ACS patients

Janssen Research & Development, LLC announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of XARELTO, an oral anticoagulant, to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome.

10 May 2012

FDA approves St. Jude Medical’s Ellipse ICD

St. Jude Medical, Inc., a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval of its Ellipse implantable cardioverter defibrillator (ICD).

10 May 2012

Combination of Pressure Right device and antiemetics effective in reducing PONV

Pressure Point Inc. stated in a recent press release that in a peer reviewed research article appearing in the Anesthesia & Analgesia Journal last month entitled: Use of Disposable Acupressure Device, its Pressure Right acustimulation disposable (adhesive) wrist device confirmed a positive advantage when used as part of a multimodal antiemetic regimen. The clinical effects of the Pressure Right acupressure technique in a sham-controlled study comparison demonstrated a definite impact in reducing PONV.

9 May 2012

Human Gene Therapy highlights new advances in human retinal disease

Gene therapy strategies to prevent and treat inherited diseases of the retina that can cause blindness have progressed rapidly. Positive results in animal models of human retinal disease continue to emerge, as reported in several articles published in Human Gene Therapy, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers.

9 May 2012

BioScrip first quarter revenue increases 19.0% to $24.8M

BioScrip, Inc. today announced 2012 first quarter financial results. First quarter revenue was $155.6 million and net loss was $2.7 million, or $0.05 per share. Consolidated Adjusted EBITDA for the first quarter was $8.4 million.

9 May 2012

C3BS’s C-Cath Injection Catheter receives CE Marking

The Belgian biotechnology company, Cardio3--BioSciences, a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases, today announces that it has received CE Marking for its intra-myocardial C-Cath Injection Catheter.

9 May 2012

Option for couples to test together, access ART for prevention can reduce HIV risk

"If we don't leverage the power of innovation to transform how health services are provided and utilized, efforts to stop new HIV infections and AIDS-related deaths can reach a stalemate," UNAIDS Executive Director Michel Sidibe writes in this opinion piece in the Huffington Post's "Healthy Living" blog.

9 May 2012

Non-drug therapy with NeuroStar TMS improves depression symptoms and QOL

New data released today at the annual meeting of the American Psychiatric Association show that patients with unipolar, non-psychotic Major Depressive Disorder (MDD) receiving transcranial magnetic stimulation (TMS) with NeuroStar TMS Therapy achieved significant improvements in both depression symptoms and in quality of life measurements.

9 May 2012

Current anticoagulant therapy to prevent stroke might not be sufficient for older women with AF

In a study that examined use of the anticoagulant medication warfarin and risk of stroke following a diagnosis of atrial fibrillation in older patients, women, especially those 75 years or older, had a higher risk of stroke than men, regardless of their risk profile and use of warfarin, suggesting that current anticoagulant therapy to prevent stroke might not be sufficient for older women, according to a study in the May 9 issue of JAMA.

9 May 2012

Teva first quarter net revenues increase 25% to $5.1 billion

Teva Pharmaceutical Industries Ltd. today reported results for the quarter ended March 31, 2012.

9 May 2012

Results reported for clinical trial for the treatment of depression using external trigeminal nerve stimulation

Earlier today, at the American Psychiatric Association Annual Meeting in Philadelphia, Dr. Ian Cook, Principal Investigator and Professor of Psychiatry at UCLA, and a Senior Medical Advisor to NeuroSigma, Inc., presented the results of a Phase Ib open-label clinical trial that studied the effects of eTNS™ on depressive symptoms in Major Depressive Disorder (MDD) as an adjunct to pharmacotherapy. Results from the 17-question Hamilton Depression Rating Scale (HDRS-17), a clinician-rated scale, showed a 50.0% reduction in depression and the Beck Depression Inventory (BDI), a self-reported scale, showed a 58.0% reduction in scores. Both scales achieved statistical significance. In the trial, subjects placed stimulating eTNS™ electrodes on their foreheads for 8 hours each night and their depression was measured every two weeks using recognized standard tests. eTNS was well tolerated and no serious adverse events occurred during the 8-week treatment period.

9 May 2012

Bumped kinase inhibitors may control malaria

Over 200 million people contract malaria each year, and according to the World Health Organization, an estimated 655,000 people died from malaria in 2010. Malaria is caused by the parasite Plasmodium, which is transmitted to humans through mosquito bites. More effective control of malaria will require the development of new tools to prevent new infections.

9 May 2012

Rutin may inhibit formation of blood clots

A compound called rutin, commonly found in fruits and vegetables and sold over the counter as a dietary supplement, has been shown to inhibit the formation of blood clots in an animal model of thrombosis.

9 May 2012

Two studies suggest long-term value of Deplin in treating MDD

Two studies presented this week at the 164th Annual Meeting of the American Psychiatric Association suggest the long-term value of Deplin (L-methylfolate 15mg) in treating major depressive disorder (MDD) and describe subsets of patients who may benefit more robustly from this medical food.

9 May 2012

Sorin launches FDA-approved PARADYM RF family of ICDs and CRT-D devices

Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announced today at Heart Rhythm 2012, the Heart Rhythm Society's 33rd Annual Scientific Sessions, FDA approval and commercial launch of the PARADYM RF family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices.

9 May 2012

eTNS therapy can impact symptoms in pharmacoresistant major depression

9 May 2012

Research grants on facioscapulohumeral dystrophy prove useful as genetic basis is found

Businessman Bill Moss’s determination to fight his untreatable muscle-wasting disease may have paid off. Four years ago, Mr Moss, a former Macquarie Bank Executive Director, established a charitable research foundation, FSHD Global, which partly funded the Italian researchers who made the breakthrough.

8 May 2012

Rexahn submits Phase II protocol for Archexin clinical study for ovarian cancer

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted a Phase II protocol for the clinical study of Archexin as a treatment of ovarian cancer to the U.S. Food and Drug Administration (FDA).

8 May 2012

Covidien to unveil new OneShot renal denervation system at EuroPCR congress

Covidien, a leading global provider of healthcare products, will unveil its new OneShot renal denervation system at the EuroPCR congress in Paris, France, on May 16, 2012. Adding to the Company's broad and growing vascular therapies portfolio, the OneShot system is designed to treat patients with hypertension who are not responsive to traditional medical therapy.

8 May 2012

FDA approves St. Jude Medical's Assura family of implantable defibrillators

St. Jude Medical, Inc., a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval of its Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

8 May 2012