FDA Approves First Drug to Prevent GVHD in Cancer Patients FDA Approves First Drug to Prevent GVHD in Cancer Patients
Abatacept is the first drug approved for the prevention of acute graft-vs-host disease. Real-world evidence was part of the approval review.FDA Approvals (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - December 15, 2021 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
FDA approves abatacept for prophylaxis of acute graft versus host disease
On December 15, 2021, the Food and Drug Administration approved abatacept (Orencia, Bristol-Myers Squibb Company) for the prophylaxis of acute graft versus host disease (aGVHD) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Approves First Drug to Prevent Graft Versus Host Disease
SILVER SPRING, Md., Dec. 15, 2021 -- (Healthcare Sales & Marketing Network) -- Today, the U.S. Food and Drug Administration approved Orencia (abatacept) for the prophylaxis (prevention) of acute graft versus host disease (aGVHD), a condition that occurs w... Biopharmaceuticals, FDA Bristol Myers Squibb, Orencia, abatacept, Graft Versus Host (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 15, 2021 Category: Pharmaceuticals Source Type: news
U.S. Food and Drug Administration Approves Orencia (abatacept) in Combination with a Calcineurin Inhibitor and Methotrexate for the Prevention of Acute Graft Versus Host Disease (aGvHD)
PRINCETON, N.J.--(BUSINESS WIRE) December 15, 2021 -- Bristol Myers Squibb (NYSE:BMY) today announced that Orencia (abatacept) was approved by the U.S. Food and Drug Administration (FDA) for the prophylaxis, or prevention, of acute graft... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 15, 2021 Category: Drugs & Pharmacology Source Type: news
Abatacept Shows Signal to Delay Onset of Rheumatoid Arthritis Abatacept Shows Signal to Delay Onset of Rheumatoid Arthritis
Early results of a randomized clinical trial show that a 6-month course of abatacept may delay or prevent progression to rheumatoid arthritis.Medscape Medical News (Source: Medscape Rheumatology Headlines)
Source: Medscape Rheumatology Headlines - November 8, 2021 Category: Rheumatology Tags: Rheumatology News Source Type: news
New Analyses Suggest Favorable Results for STELARA ® (ustekinumab) When Used as a First-Line Therapy for Bio-Naïve Patients with Moderately to Severely Active Crohn’s Disease and Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, October 25, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from two new analyses of STELARA® (ustekinumab) for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC).1,2 In a modelled analysisa focused on treatment sequencing using data from randomized controlled trials, network meta-analysis and literature, results showed patient time spent in clinical remission or response was highest when STELARA was used as a first-line advanced therapy for bio-naïve patients with moderately to severely acti...
Source: Johnson and Johnson - October 25, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Abatacept as Treatment for Diffuse Cutaneous Systemic Sclerosis Abatacept as Treatment for Diffuse Cutaneous Systemic Sclerosis
' Exploratory outcome measures during the open-label extension, including the composite ACR CRISS score, indicate that abatacept might promote overall global improvement in these participants. 'Medscape Medical News (Source: Medscape Dermatology Headlines)
Source: Medscape Dermatology Headlines - October 29, 2020 Category: Dermatology Tags: Rheumatology News Source Type: news
Upadacitinib Tops Abatacept for RA Refractory to DMARDs
FRIDAY, Oct. 16, 2020 -- Upadacitinib is superior to abatacept for patients with rheumatoid arthritis refractory to biologic disease-modifying antirheumatic drugs (DMARDS), according to a study published online Oct. 15 in the New England Journal of... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - October 16, 2020 Category: Pharmaceuticals Source Type: news
Upadacitinib More Effective, Less Safe Than Abatacept for RA Upadacitinib More Effective, Less Safe Than Abatacept for RA
Upadacitinib (Rinvoq) proved superior to abatacept in both disease activity and remission for patients with rheumatoid arthritis, yet led to more adverse events.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - October 15, 2020 Category: Drugs & Pharmacology Tags: Rheumatology News Source Type: news
SIMPONI ARIA ® (golimumab) Approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older
HORSHAM, PA, September 30, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI ARIA® (golimumab) for patients 2 years of age and older for the treatment of active pJIA and has extended the PsA indication for this same patient population. “This latest FDA approval of SIMPONI ARIA for pediatric use in active pJIA and active PsA not only brings a new option to young patients living with these diseases but also adds to the growing body of evidence for this treatment,” said Mathai Mammen, M.D., Ph.D., Global Head, Jans...
Source: Johnson and Johnson - September 30, 2020 Category: Pharmaceuticals Source Type: news
RA Infection Risk With Abatacept, Rituximab and Tocilizumab RA Infection Risk With Abatacept, Rituximab and Tocilizumab
How common are infections among rheumatoid arthritis patients receiving treatment with these non-TNF-inhibitors?Rheumatology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 28, 2020 Category: Consumer Health News Tags: Rheumatology Journal Article Source Type: news
Janssen Announces Submission of Two Applications to U.S. FDA Seeking Approval of SIMPONI ARIA ® (golimumab) for the Treatment of Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis
HORSHAM, PA, April 24, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA® (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), in patients two years of age and older in combination with methotrexate. If approved for these indications, SIMPONI ARIA would be the first anti-tumor necrosis factor (TNF)-alpha biologic agent administered by intravenous infusion available...
Source: Johnson and Johnson - April 24, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
Abatacept More Effective in bDMARD-Naive Patients With RA Abatacept More Effective in bDMARD-Naive Patients With RA
Data from the Swedish Rheumatology Quality register for all patients treated with abatacept for RA showed best results for those with no prior bDMARD exposure, those with less active disease, and males.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 30, 2020 Category: Consumer Health News Tags: Rheumatology News Source Type: news
Havertown Doctor Pleads Guilty to Unlawfully Importing Foreign, Injectable Drugs and Unlawfully Distributing Oxycodone
Thomas Whalen, Havertown PA, Guilty plea, importation, heath care fraud, oxycodone, D.O., controlled substance, Whalen Rheumatology Group, Exton PA, Wilmington DE, Unapproved, Injection, Infusion, Remicade Synvisc, Synvisc-One, Orencia, Prolia/Xgeva, Boniva (Source: Office of Criminal Investigations (OCI) Press Releases)
Source: Office of Criminal Investigations (OCI) Press Releases - December 19, 2019 Category: Medical Law Authors: DOJ Source Type: news
FDA Grants Breakthrough Therapy Designation to Abatacept for Acute GVHD Prevention
The FDA granted a breakthrough therapy designation to abatacept for the prevention of moderate to severe acute graft-versus-host disease in hematopoietic stem cell transplants from unrelated donors. (Source: CancerNetwork)
Source: CancerNetwork - December 4, 2019 Category: Cancer & Oncology Authors: Kristie L. Kahl Source Type: news
