Law enforcement by the US FDA lacks conviction

Pakistan remains a country of vital importance for Al-Qaeda. It is primarily because of Al-Qaeda’s advent, rise and shelter and not to mention the support the terrorist organization found at the landscape of Pakistan during the last two decades. The emergence of in Pakistan can be traced back to the Afghan War (1979-89), with a brief sabbatical in Sudan the Islamist terrorist group rose to gain prominence after shifting back to Afghanistan. It then became a global ‘Islamist’ terrorist entity while based in neighboring Afghanistan and found safe havens in the erstwhile tribal areas of Pakistan in the aftermath of the US invasion of Afghanistan in 2001. Prior to its formation in 1988 in Peshawar (Pakistan), it had worked as Maktab al-Khidmat (Services Bureau) during the Afghan War.2 It had its roots in Pakistan, which had become a transit point of extremists en route to Afghanistan during the War. All high profile Al-Qaeda leaders, later becoming high-value targets, and members of its central Shura had lived in Pakistan at one point in their lives. That is the very reason the Al-Qaeda in Pakistan is termed as Al-Qaeda Core or Central among law enforcement practitioners and intelligence communities. Without going into details of Al-Qaeda’s past in Pakistan the aim of this article is to focus on its current state of affairs and what future lies ahead of it in Pakistan.

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Regulatory decisions from the US FDA

Inpharma Weekly ◽

10.2165/00128413-200112720-00058 ◽

2001 ◽

Vol &NA; (1272) ◽

pp. 22

Author(s):

&NA;

Keyword(s):

The Us ◽

Us Fda ◽

Regulatory Decisions

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

Therapeutic Advances in Hematology ◽

10.1177/2040620719874728 ◽

2019 ◽

Vol 10 ◽

pp. 204062071987472 ◽

Cited By ~ 12

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.

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

Antiviral Chemistry and Chemotherapy ◽

10.1177/2040206619829382 ◽

2019 ◽

Vol 27 ◽

pp. 204020661982938 ◽

Cited By ~ 34

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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