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
Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone. Another busy day is on the way. This is to be expected, though, yes? After all, not much gets accomplished when one is sitting still. Just the same, we are able to enjoy a warm sun hovering over the Pharmalot corporate campus, where the mascots are lounging, the short people are hustling off, as usual, to their houses of learning and another cup of stimulation is brewing in the cafeteria. And this is our signal to get cracking. Meanwhile, here are some items of interest. Hope you have a grand day and keep us in mind if you run across anything interesting...
Biosimilars Are Slow To Take Off In Euro...
Source: Pharmalot - December 3, 2013 Category: Pharma Commentators Authors: esilverman 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
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and welcome to the middle of the week. A strong sun is beaming over the Pharmalot corporate campus this morning, where another a very busy day is shaping up. But busy is good as they say. So no time to dawdle. Please join us as we reach for a cup of stimulation - our choice today, however, is mango ceylon tea with a dollop of honey. A little change of pace can be a good thing, yes? Meanwhile, here are some tidbits. Have a grand day and drop us a line if you hear something we would want to know...
J&J May Pay $4B To Settle Hip Implant Litigation (Bloomberg News)
FDA Review Supports Vanda Sleep Di...
Source: Pharmalot - November 13, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone, the middle of the week is here. If you can make it through today, the rest should be downhill, yes? Well, we are among the optimists, after all. Meanwhile, there is much to do, as always. So, no time to waste. Please join us as we reach for that needed cup of stimulation and brace for another round of phone calls, meetings and document reading. We trust you can relate. To help you along, yes, we have some tidbits. Have a grand day and do keep us in mind when something fascinating pops up...
Regeneron Drug Lowers Cholesterol In Late-Stage Trial (Reuters)
Glaxo Exec Assists China In Bribery Probe, B...
Source: Pharmalot - October 16, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone. Another sunny day is on the way. Moreover, we are graced with a deliciously cool breeze this morning, as well. All in all, a lovely atmosphere for attacking the workload, yes? So no need to delay. Grab a cup of something stimulating, reach for your to-do list and make a good effort. Meanwhile, here are a few tidbits to start you off. Have a swell day and do stay in touch...
Dementia Drugs Do Not Help Mild Cognitive Impairment (MedPage Today)
UK Docs Warned Of Hemophilia Risk With Sanofi's Plavix (Pharma Times)
Chiesi To Buy Rest Of Cornerstone Therapeutics (Reuters)
EU Approves Sanofi MS Drug Lemt...
Source: Pharmalot - September 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Another Drug for Alzheimer's Flops
Another promising treatment for Alzheimer's has failed to provide any evidence that it reduces cognitive decline and preserves functional abilities in patients with mild to moderate Alzheimer's disease.
+Alzheimer's Reading Room
Another Phase 3 clinical trial for the purpose of finding a treatment for Alzheimer's has failed and ended.
Intravenous immunoglobulin (IVIG) failed to stop Alzheimer's in patients with mild to moderate Alzheimer's disease.
This is just another round of dissapointing and disconcerting news for the entire Alzheimer's community worldwide.
According to the World Health Organization (WHO) someo...
Source: Alzheimer's Reading Room, The - May 9, 2013 Category: Dementia Authors: Bob DeMarco Source Type: blogs
FDA: Enhancing Benefit-Risk Assessment in Regulatory Decision Making
Last summer, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA), which included the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Title I of FDASIA reauthorizes the Prescription Drug User Fee Act (PDUFA), which provides FDA with the necessary user fee resources to maintain an efficient review process for human drug and biologic products. The reauthorization of PDUFA includes performance goals and procedures that represent FDA’s commitments during FY 2013-2017. These commitments are referred to in section 101 of FDASIA.
Section X of these commitments relates ...
Source: Policy and Medicine - April 25, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
Tranexamic Acid (TXA).
Around 25% of severe trauma patients experience acute coagulopathies associated with increased morbidity and mortality rates.
Recently, we have seen an increased understanding of the relationship between trauma and alterations to the coagulation system. A little ironically, this knowledge has been gained largely from battlefield experience including Iraq and Afghanistan.
Tranexamic Acid (TXA) is an antifibrinolytic. That is, it inhibits the activation of plasminogen (and plasmin) thereby preventing the breakdown of existing clots.
One of the negative responses to an acute traumatic event is the muting of the bodies plasmin...
Source: impactEDnurse - January 1, 2013 Category: Nurses Authors: impactEDnurse Tags: the nurses desk: Source Type: blogs
