The US FDA requires a "new vision of drug safety"

2006 ◽  
Vol &NA; (1126) ◽  
pp. 3
Author(s):  
&NA;
Keyword(s):  
Drug Safety ◽  
The Us ◽  
New Vision ◽  
Us Fda

Update on the Office of Drug Safety at the US FDA

2004 ◽  
Vol &NA; (1015) ◽  
pp. 3-4
Author(s):  
R Stather
Keyword(s):  
Drug Safety ◽  
The Us ◽  
Us Fda

Regulatory decisions from the US FDA

2001 ◽  
Vol &NA; (1272) ◽  
pp. 22
Author(s):  
&NA;
Keyword(s):  
The Us ◽  
Us Fda ◽  
Regulatory Decisions

Global Economic Management in the 1990s

2018 ◽  
Keyword(s):  
Soviet Union ◽  
International Economy ◽  
Economic Management ◽  
Poor Countries ◽  
Global Management ◽  
Bretton Woods ◽  
Income Gap ◽  
The Us ◽  
New Vision ◽  
Bretton Woods Institutions

In the chapter, Haq considers the challenges for global economic management that the nineties may bring. He highlights five distinct trends that have emerged in the international economy in the previous quarter of a century: the globalization of markets, decline in the influence of the US, emerging importance of China and Soviet Union, and narrowing of income gap between rich and poor countries. In the light of these trends, Haq stresses on the need for a new vision for Bretton Woods institutions to serve a greater role in global management in the decade of the nineties.

scholarly journals Ravulizumab: a novel C5 inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria

2019 ◽  
Vol 10 ◽  
pp. 204062071987472 ◽  
Author(s):  
Robert M. Stern ◽  
Nathan T. Connell
Keyword(s):  
Paroxysmal Nocturnal Hemoglobinuria ◽  
Bone Marrow Failure ◽  
Phase Iii ◽  
The European Union ◽  
Regulatory Review ◽  
Dosing Schedule ◽  
The Us ◽  
United States Food ◽  
States Food ◽  
Us Fda

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare stem cell disorder characterized by hemolytic anemia, bone marrow failure, and thrombosis. Until recently, the complement inhibitor, eculizumab, was the only United States Food and Drug Administration (US FDA)-approved therapy for the treatment of PNH. Although effective, eculizumab requires a frequent dosing schedule that can be burdensome for some patients and increases the risk of breakthrough intravascular hemolysis. Ravulizumab, an eculizumab-like monoclonal antibody engineered to have a longer half-life, is intended to provide the same benefits as eculizumab but with a more convenient and effective dosing schedule. In two recently published phase III non-inferiority trials, ravulizumab was found to be non-inferior to eculizumab both in efficacy and safety for the treatment of patients with PNH. Based on these results, ravulizumab was approved by the US FDA on 21 December 2018 and is currently under regulatory review in both the European Union and Japan.

scholarly journals Mozobil® (Plerixafor, AMD3100), 10 years after its approval by the US Food and Drug Administration

2019 ◽  
Vol 27 ◽  
pp. 204020661982938 ◽  
Author(s):  
Erik De Clercq
Keyword(s):  
Autologous Transplantation ◽  
Hepatopulmonary Syndrome ◽  
Blood Stream ◽  
Malignant Diseases ◽  
Whim Syndrome ◽  
Natural Ligand ◽  
Cxcr4 Receptor ◽  
The Us ◽  
Us Fda ◽  
Anti Hiv

AMD3100 (plerixafor, Mozobil®) was first identified as an anti-HIV agent specifically active against the T4-lymphotropic HIV strains, as it selectively blocked the CXCR4 receptor. Through interference with the interaction of CXCR4 with its natural ligand, SDF-1 (also named CXCL12), it also mobilized the CD34+stem cells from the bone marrow into the peripheral blood stream. In December 2008, AMD3100 was formally approved by the US FDA for autologous transplantation in patients with Non-Hodgkin’s Lymphoma or multiple myeloma. It may be beneficially used in various other malignant diseases as well as hereditary immunological disorders such as WHIM syndrome, and physiopathological processes such as hepatopulmonary syndrome.

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