The future is bright for RWE in pharma approvals
Real-world evidence (RWE) could help pharma achieve many things – including understanding disease burden better and smarter monitoring of newly marketed therapies to make them safer and more effective. But the most promising near-term use case for RWE, according to a Deloitte survey of pharma executives, is in support of regulatory submissions and label expans ion. For industry stakeholders such as Marc Berger, M.D., this advance is a long time coming. The founder of the real-world data (RWD) and analytics group at Pfizer, Berger has been a contributing author on dozens of policy papers on the use of RWE – including ...
Source: EyeForPharma - January 6, 2022 Category: Pharmaceuticals Authors: Brian Eastwood Source Type: news
FDA approves new use of transplant drug based on real-world evidence
Approval of Prograf (tacrolimus) Using Real-World Evidence (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Approval Demonstrates the Role of Real-World Evidence in Regulatory Decision-Making on Drug Effectiveness
FDA recently approved Prograf (tacrolimus) in combination with other immunosuppressant drugs for the new indication of preventing organ rejection in adult and pediatric patients receiving lung transplantation. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 4, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news
U.S. Food and Drug Administration Expands Indication for Prograf for Prevention of Organ Rejection in Adult and Pediatric Lung Transplant Recipients
NORTHBROOK, Ill., July 20, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 20, 2021 Category: Drugs & Pharmacology Source Type: news
FDA Approves Tacrolimus for Lung Transplants FDA Approves Tacrolimus for Lung Transplants
The drug is the only immunosuppressant approved for the prevention of organ rejection in both adult and pediatric patients undergoing lung transplant. It has been used in lung transplant for 15 years.FDA Approvals (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - July 19, 2021 Category: Surgery Tags: Transplantation News Alert Source Type: news
FDA Approves New Use of Transplant Drug Based on Real-World Evidence
Approval of Prograf (Tacrolimus) Using Real-World Evidence (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Sitagliptin Promising Addition for Preventing Acute GVHD
THURSDAY, Jan. 7, 2020 -- For patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation, sitagliptin combined with tacrolimus and sirolimus results in a low incidence of grade II to IV acute graft-versus-host disease... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 7, 2021 Category: Pharmaceuticals Source Type: news
Lupin, Concord Biotech get USFDA nod for generic immunosuppressant capsules
In alliance with Concord Biotech, the company has received approval from the United States Food and Drug Administration (USFDA) to market Tacrolimus capsules USP, in the strengths of 0.5 mg, 1 mg, and 5 mg, Lupin said in a filing to the BSE. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 12, 2020 Category: Pharmaceuticals Source Type: news
Glenmark Pharma gets USFDA nod for Tacrolimus capsules
Glenmark Pharmaceuticals Inc, USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for Tacrolimus Capsules USP in the strengths of 0.5 mg, 1 mg and 5 mg, Glenmark said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 11, 2020 Category: Pharmaceuticals Source Type: news
Novel tool for tacrolimus monitoring promising, feasible, no cost saving
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 29, 2020 Category: Drugs & Pharmacology Source Type: news
Tacrolimus and not cyclosporin A or sirolimus interacts synergistically in vitro with isavuconazole against Aspergillus species
Conference abstracts (Source: The Aspergillus Website - updates)
Source: The Aspergillus Website - updates - November 8, 2019 Category: Respiratory Medicine Authors: MeganB Source Type: news
Immunosuppressive drug combo keeps lung transplant patients alive longer
Lung transplant patients in a recent study who took a mix of two immunosuppressive drugs, sirolimus and tacrolimus, had a median survival rate of nearly nine years -- two more than the most commonly used combination. (Source: Health News - UPI.com)
Source: Health News - UPI.com - August 29, 2019 Category: Consumer Health News Source Type: news
What is This Itchy Rash?
Discussion
Atopic dermatitis (AD) has a prevalence of 3-5% in the overall U.S. population but is increasing with an estimated 10-15% lifetime risk in childhood. It is even more common in children of color with a prevalence in African-American/black children of 17% and Hispanic children of 14%. Health care utilization data also appears to support more severe disease in children of color also.
Atopic dermatitis or eczema is a common dermatological skin problem which characteristically is a pruritic, papular eruption with erythema. Like most papulosquamous eruptions it often occurs in intertrigenous areas in people with alle...
Source: PediatricEducation.org - July 1, 2019 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news
Podcast: Immunosuppressive treatment for people with proliferative lupus nephritis
Systemic lupus erythematosus, or SLE, is an autoimmune disease that can affect any part of the body. About half the people with it develop lupus nephritis. In the June 2018 update of their Cochrane Review, David Tunnicliffe from the Centre for Kidney Research in the Children ’s Hospital at Westmead and the University of Sydney’s School of Public Health in Australia and colleagues brought together the studies that have tested a range of treatments." Lupus nephritis is a serious condition, leading to end-stage kidney disease in 15% of patients after 10 years. It mainly affects women of child-bearing age, and is more comm...
Source: Cochrane News and Events - May 30, 2019 Category: Information Technology Authors: Lydia Parsonson Source Type: news
Update on the Use of Tacrolimus in Pediatrics Update on the Use of Tacrolimus in Pediatrics
This article provides an update for its use in children.Pediatric Pharmacotherapy (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - March 18, 2019 Category: Allergy & Immunology Tags: Pediatrics Journal Article Source Type: news
