Bleeding Disorders

Anticoagulants Taken With Certain Meds May Up Bleeding Risk

October 05, 2017

And antithrobotic medications linked to higher rate of hematuria-related events in older adults

Prophylaxis vs. On Demand Tx in Patients with Severe Hemophilia

August 31, 2017

Overall, 35.7% of prophylaxis participants were bleed-free and 76.2% had fewer than 2 BEs per year.

BLA for Novel Hemophilia A Therapy Granted Priority Review

By August 24, 2017

The FDA has accepted and granted Priority Review to the Biologics License Application (BLA) of emicizumab (Genentech) for the prophylactic treatment of hemophilia A in adults, adolescents and children with factor VIII inhibitors.

FDA Approves Additional Vial Strengths of Nuwiq for Hemophilia A

By August 22, 2017

In addition to the currently available strengths (250, 500, 1000, 2000 IU), starting in September, Nuwiq will also be supplied in 2500, 3000, and 4000 IU vial strengths.

Caplacizumab Fast-Tracked for Acquired Thrombotic Thrombocytopenic Purpura

By July 26, 2017

The Phase 2 TITAN study (n=75) evaluated the safety and efficacy of caplacizumab with standard of care of plasma exchange and immunosuppression.

Idarucizumab Effective for Dabigatran Reversal in Emergency Situations

July 13, 2017

Effective for dabigatran reversal among patients with uncontrolled bleeding, undergoing urgent surgery

Emicizumab Beneficial in Hemophilia A Patients With Inhibitors to FVIII

By June 29, 2017

The primary analysis of the study arm showed a statistically and clinically significant reduction in bleeding by 87% (risk rate [RR] 0.13; P<0.0001] with emicizumab prophylaxis.

NDA Filed for Tavalisse for Immune Thrombocytopenia Treatment

By June 19, 2017

Tavalisse is an oral treatment designed to inhibit SYK kinase, a key signaling member in the immune process that leads to platelet destruction in ITP.

PPIs May Benefit Older Patients on Antiplatelet Therapy

June 15, 2017

Research suggests proton-pump inhibitors should be co-prescribed in patients age 75 years

Anticoagulation During Pregnancy Linked to Distinct Maternal, Fetal Risks

June 02, 2017

VKA, LMWH tied to lowest risk of adverse maternal, fetal outcomes, respectively

Rebinyn Approved to Treat Hemophilia B

By June 01, 2017

Rebinyn, a recombinant DNA-derived coagulation Factor IX concentrate, temporarily replaces the missing coagulation Factor IX in hemophilia B patients.

Novel Hemophilia A Gene Therapy Gets Fast Track Status

By May 16, 2017

The Food and Drug Administration (FDA) has granted Fast Track designation to SB-525 (Sangamo Therapeutics) for the treatment of hemophilia A.

FDA to Review Fostamatinib for Chronic, Persistent ITP

By April 18, 2017

Rigel announced its submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for fostamatinib for the treatment of patients with chronic and persistent immune thrombocytopenic purpura (ITP).

Emicizumab Evaluated in Children with Hemophilia A

By April 17, 2017

The interim results from HAVEN 2, after a median of 12 weeks of treatment, showed that prophylaxis with emicizumab is associated with clinically meaningful reduction in the number of bleeds over time.

Major Bleeding Risk Similar with Antiplatelets, OAs in Elderly AF Patients

April 17, 2017

Elderly taking aspirin, clopidogrel have major bleeding similar to that seen with oral anticoagulants

Is tPA Use Safe for Sickle Cell Patients in Acute Ischemic Stroke?

By April 11, 2017

Commenting on the study's results, lead author Robert J. Adams, MD, said, "Having sickle cell disease did not adversely affect any of the indicators we measured."

First Consumer Genetic Health Risk Tests Get FDA Approval

By April 06, 2017

While the GHR tests may provide genetic risk information, they cannot determine a person's overall risk for developing a disease, as other factors beyond genetics (ie, environment, lifestyle) may also influence risk.

Intracranial Bleed Risk Compared for Apixaban, Warfarin in A-fib Patients

By March 29, 2017

Patients taking apixaban showed significantly less intracranial hemorrhage (0.33% per year) vs. patients taking warfarin (0.80% per year) no matter the type and location.

CV, Bleeding-Related Mortality Examined Post-Coronary Stenting

By March 24, 2017

Fifty-two (10.9%) of the patients who experienced an ischemic event, and 41 (17.7%) who suffered experieced a bleeding event, died.

Nipride RTU Approved for Immediate BP Reduction

By March 10, 2017

Nipride RTU is approved for immediate blood pressure reduction and also carries a Boxed Warning describing the possibility of excessive hypotension and cyanide toxicity.

Investigational Hemophilia B Gene Therapy Granted Breakthrough Status

By January 30, 2017

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational gene therapy, AMT-060 (uniQure), for the treatment of severe hemophilia B.

FDA Review Underway for Eptacog Beta in Hemophilia

By January 06, 2017

LFB S.A. announced that the FDA has accepted for review the Biologic License Application (BLA) of its recombinant Coagulation Factor VIIa (eptacog beta, activated) for the potential treatment of congenital hemophilia A or B in adolescents and adults with inhibitors.

Red Cross: Urgent Call for Blood, Platelet Donations

By January 04, 2017

The American Red Cross has announced an emergency call for blood and platelet donations today following a severe winter blood shortage. Eligible donors are being asked to schedule an appointment to give blood.

Hemophilia A Treatment Gains Expanded Approval

By December 27, 2016

Adynovate, an extended circulating half-life recombinant Factor VIII (rFVIII), was initially approved for use in patients aged ≥12 years with hemophilia A for on-demand treatment and control of bleeding episodes, and routine prophylaxis to reduce the frequency of bleeding episodes.

Emicizumab Prophylaxis Reduced Number of Bleeds in Hemophilia A Trial

By December 22, 2016

The primary endpoint was the number of bleeds over time among patients with emicizumab prophylaxis or no prophylaxis.

Transfused RBC Storage and Mortality Rates Assessed in Large Cohort

December 20, 2016

For patients who received transfusions in Sweden and Denmark from 2003 to 2012, there was no correlation between the length of red blood cell (RBC) storage and mortality, according to a study published online December 20 in the Annals of Internal Medicine.

Novel Single-Dose Gene Therapy Improves Clotting Factor IX in Hemophilia B

December 08, 2016

A single dose of an experimental gene therapy may benefit patients with hemophilia B, according to trial results presented at the annual meeting of the American Society of Hematology

Certain Antidepressants May Up Risk of Intracranial Hemorrhage

By December 05, 2016

The cohort included 1,363,990 incident users of antidepressants.

Review: Vitamin K Supplementation

November 15, 2016

In addition to its role in hemostasis, vitamin K plays a pivotal role in the metabolism of calcium in the human body.

Case: Recurrent Immune Thrombocytopenia After Flu Shot

November 09, 2016

In a report published online November 8 in Pediatrics, authors present the case of recurrent immune thrombocytopenia (ITP) after influenza vaccination.