FDA Approves Kcentra for the Urgent Reversal of Anticoagulation in Adults with Major Bleeding

30 04 2013

New Drug Approvals

April 29, 2013

The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.

Patients receiving chronic anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting in conditions such as atrial fibrillation or the presence of an artificial heart valve sometimes develop acute bleeding. Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse the anticoagulation effect and stop the bleeding. Unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma.

“The FDA’s approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA anticoagulation,” said Karen Midthun, M.D., director…

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BioLineRx Enrolls First Patient in Phase I/II Clinical Trial for BL-8020, an Oral, Interferon-Free Treatment for Hepatitis C

30 04 2013




Scioderm’s SD-101 Receives Breakthrough Therapy Designation from FDA for Treatment of Epidermolysis Bullosa

30 04 2013

New Drug Approvals

DURHAM, N.C., April 29, 2013 Scioderm announced its investigational product SD-101 has received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with inherited Epidermolysis Bullosa (EB). SD-101 is Scioderm’s investigational therapy that is being evaluated for the treatment of skin blistering and erosions associated with this disease, including facilitation of healing of skin lesions and reduction of the incidence and/or severity of new lesions.

read all at

http://www.stockrants.com/2013/04/29/scioderms-sd-101-receives-breakthrough-therapy-designation-from-fda-for-treatment-of-epidermolysis-bullosa.html

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CVRx Gains Full FDA Approval for Barostim neo Hypertension Study

30 04 2013

New Drug Approvals

investigational device exemption (IDE) approval

Barostim neo

MINNEAPOLIS, April 29, 2013

CVRx, Inc., a private medical device company, received Food and Drug Administration (FDA) investigational device exemption (IDE) approval, allowing the company to proceed with its hypertension study

read all

http://www.stockrants.com/2013/04/29/cvrx-gains-full-fda-approval-for-hypertension-study.html

Barostim neo is designed to use the body’s own natural blood flow regulation system to treat hypertension.

http://www.cvrx.com/int/

 

The system works by electrically activating baroreceptors, the body’s natural blood pressure sensors that regulate cardiovascular function. When the Barostimneo is activated, signals are sent through neural pathways to the brain, which responds by telling the arteries to relax, the heart to slow down and the kidneys to reduce fluid in the body, lowering excessive blood pressure and workload on the heart.

http://www.cvrx.com/int/  play video

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Regenerative Medicine: Polymer coating could help stem cells target inflamed blood vessels to regrow healthy tissue

30 04 2013

New Drug Approvals

Mouse embryonic stem cells.jpg

People with chronic diseases like diabetes and multiple sclerosis have inflamed, leaky blood vessels, heightening their risk of heart attack and stroke. Some scientists envision using a patient’s own stem cells to regrow healthy tissue to plug the leaks and calm inflammation. A new polymer coating could help these stem cells find and adhere to inflamed endothelial tissue (J. Am. Chem. Soc., DOI: 10.1021/ja400636d).

read all at

http://cen.acs.org/articles/91/web/2013/04/Putting-Stem-Cells-Place.html

Chemical & Engineering News Serving The Chemical, Life Sciences & Laboratory Worlds

 

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Daiichi Sankyo enrolls first patient in Nimotuzumab Phase 3 clinical trials

30 04 2013




Top 20 Best-Selling Drugs Approved and Launched During 2012

30 04 2013







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