Popular Blood-thinner Manufacturer Didn’t Want Internal Research Made Public
Boehringer Ingelheim, the manufacturer of the blood-thinning drug Pradaxa, was concerned that releasing the results of an internal research paper on the drug would damage drug sales, records recently made public show. The company was so worried about the results of the study that some employees pressured the author to revise it, and the company recommended it be thrown out, according to a recent report by the New York Times.Records recently made public by a federal judge in Illinois presiding over thousands of lawsuits against the maker of Pradaxa, including emails, internal memos, and presentations, centered on the resear...
Source: Medical Hemostat - February 7, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Baxter sues Johnson & Johnson over FloSeal patents
Baxter (NYSE:BAX) accused Johnson & Johnson (NYSE:JNJ) of infringing 6 patents covering its FloSeal line with the Ethicon SurgiFlo line of competing surgical hemostasis products.In a lawsuit filed last week in the U.S. District Court for Northern Illinois, Baxter said the alleged infringement is willful and asked Judge Sharon Johnson Coleman for triple damages, pre- and post-judgment interest, legal costs and a jury trial."Defendants' SurgiFlo products directly compete with Baxter's biosurgery products, including the Floseal family of products, which practice the Patents-in-Suit. On information and belief, defendants a...
Source: Medical Hemostat - January 28, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Arch Therapeutics to Webcast Live From the Biotech Showcase Investor Conference
WELLESLEY, MA--(Marketwired - Jan 8, 2014) - Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), a life sciences company and developer of AC5(TM), a novel product aimed at controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, is pleased to announce that Terrence W. Norchi, M.D., CEO of Arch Therapeutics will present at The Biotech Showcase(TM) 2014 conference on Monday, January 13th, at 5:00PM PST. Attendees will find the presentation scheduled for "Track C" in the Mission II room at that time. Dr. Norchi's presentation will provide insights into the Company...
Source: Medical Hemostat - January 9, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Sealant Inspired By Beach Worm Could Become Surgical Superglue
Remember that wacky glue commercial from the 1980s? "Krazy Glue, you crazy rat," the narrator says. "Strong enough to hold this man suspended in mid-air." He promises the stuff can bond almost anything: a plastic knob, a plastic plug, a rubber boot, a door knob, and even a flashlight case.Heck, a version of the everlasting adhesive is even approved by the Food and Drug Administration to seal skin wounds.But superglue can't fix a broken heart — or even a torn artery. Yet.Now a team of doctors and engineers at Brigham and Women's Hospital in Boston are getting close to changing that. Their unlikely inspiration is a 3-inch ...
Source: Medical Hemostat - January 9, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Z-Medica Signs HealthTrust Agreement
WALLINGFORD, Conn., Jan. 6, 2014 -- /PRNewswire/ -- Z-Medica, a leading developer and marketer of hemostatic agents, announced it has signed an agreement with HealthTrust, a group purchasing and total cost management solutions company, to provide its healthcare member facilities access to QuikClot® products under a vascular closure patch category, effective January 1, 2014."Controlling bleeding in a hospital setting is essential for minimizing the length of procedures, reducing the risk of complications, reducing the cost to patients and medical facilities and improving overall patient outcomes," said Jack McCarthy,...
Source: Medical Hemostat - January 7, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Cohera Medical, Inc.® Successfully Completes Clinical Trial and Confirms Safety of Sylys® Surgical Sealant
PITTSBURGH, Dec. 10, 2013 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has successfully completed a clinical trial confirming the safety of Sylys®Surgical Sealant designed to significantly reduce anastomotic leakage in intestinal procedures. The European study included patients enrolled at two sites in the Netherlands.Sylys is one of the first synthetic sealants specifically designed to significantly reduce anastomotic leakage in intestinal anastomosis procedures. Used in conjunction with standard anastomotic...
Source: Medical Hemostat - December 11, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
New dissolving patch delivers clotting factor directly to injury to stop bleeding faster
Hemorrhage is a primary cause of mortality in trauma patients even though most injuries suffered are potentially survivable. Increasing survival is simply a matter of effectively controlling hemorrhage. Current hemostatic dressings range from simple gauze to aluminosilicates from natural or synthetic clay Combat GauzeTM, or chitosan from shellfish or algae (CeloxTM). These dressings stop the bleeding by direct compression of injured vessels and/or activation of the intrinsic coagulation pathway. In trauma patients however, this system is often compromised.Current dressings are also unstable, which increases the chance of r...
Source: Medical Hemostat - December 11, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Baxter submits application to FDA for pediatric indication of Rixubis to treat Hemophilia B
Baxter International has filed an application to the US Food and Drug Administration (FDA) for a pediatric indication for Rixubis [Coagulation Factor IX (Recombinant)] to treat hemophilia B.The submission was based on a Phase II/III clinical trial, designed to assess the efficacy and safety of Rixubis in 23 previously-treated male patients less than 12 years of age with severe or moderately severe hemophilia B.In 2013, the company had secured FDA approval for Rixubis in the US for adults with hemophilia B and it had filed for marketing approval in Europe in November.During the trial, patients were treated with a twice-week...
Source: Medical Hemostat - December 11, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Study: Closure devices cut complications after cardiac procedure (VIDEO)
The use of vascular closure devices significantly reduced complications and the need for transfusions in obese and overweight patients undergoing transfemoral percutaneous coronary intervention (PCI), but the benefit over manual closure was not seen in lean and normal-weight patients or in those treated with a glycoprotein IIb/IIIa inhibitor, researchers reported.The benefit was also counterbalanced by a small increase in risk of retroperitoneal bleeding, Hitinder S. Gurm, MD, of the University of Michigan Cardiovascular Center in Ann Arbor, and colleagues, wrote online in the Annals of Internal Medicine.Vascular closure d...
Source: Medical Hemostat - November 21, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
European Medicines Agency Accepts Marketing Authorization Application for The Medicines Company's Fibrocaps
PARSIPPANY, NJ--(Nov 21, 2013) - The Medicines Company (MDCO) today announced that the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for the investigational hemostatic agent Fibrocaps (human plasma-derived fibrinogen and thrombin). Fibrocaps was studied in the 719-patient Phase III FINISH-3 clinical trial as an adjunct to hemostasis in patients undergoing surgical procedures when control of mild or moderate bleeding by conventional surgical techniques is ineffective or impractical. The acceptance of the MAA marks the beginning of the review process in the European ...
Source: Medical Hemostat - November 21, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Clinical Papers Hemostats Reviewed - Oxi Cell, Gelatin, Collagen, Thrombin, Polysaccharide Powders
A lot of our earlier embedded document links have gone since our previous embedding agency sold (these things happen in 5 years of blogging). Now Google have this facility I am happy to provide you clinical data for your interest in the links below. (Source: Medical Hemostat)
Source: Medical Hemostat - November 19, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Clinical Papers - Bonewax, Oxidized Cellulose, Surgicel,
(Source: Medical Hemostat)
Source: Medical Hemostat - November 19, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Clinical Papers - Fibrin Sealants, BioGlue, Perclot, HaemoCer, Thrombin
(Source: Medical Hemostat)
Source: Medical Hemostat - November 19, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Cohera Medical, Inc.® Completes Fourth and Final Module in the Premarket Approval (PMA) Application for TissuGlu® Surgical Adhesive
PITTSBURGH, Nov. 19, 2013 -- PITTSBURGH, Nov. 19, 2013 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today it has submitted its fourth and final module for TissuGlu® Surgical Adhesive in the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA)."We are pleased to have submitted the final module of the PMA application for TissuGlu," said Chad Coberly, JD Vice President of Clinical, Regulatory and Legal affairs of Cohera Medical. "This module culminates substantial work by the Cohe...
Source: Medical Hemostat - November 19, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Baxter completes patient enrollment in phase III trial of BAX 855, extended half-life rFVIII to treat haemophilia A
Baxter International Inc. has completed enrollment in its phase III clinical trial of BAX 855, an investigational extended half-life, recombinant factor VIII (rFVIII) treatment for haemophilia A. The ongoing trial is aimed at assessing the efficacy of the compound in reducing annualized bleed rates (ABR) in both prophylaxis and on-demand treatment schedules, and will also evaluate its safety and pharmacokinetic profile.BAX 855 was designed based on the full-length ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] molecule, a product with 10 years of real-world experience. The BAX 855 molecule was modi...
Source: Medical Hemostat - November 15, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
