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U.S. Marshals Seize Drug Products Manufactured By Caraco Pharmaceutical Laboratories Ltd. FDA Acts To Prevent Repeated Drug Quality Problems
U.S. Marshals, at the request of the Food and Drug Administration, today seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company"s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities. "The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements," said Janet Woodcock, M.D., director of the FDA"s Center for Drug Evaluation and Research. "Compliance with these standards prevents harm to the public."
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New Strategy Proposed For Designing Antibody-Based HIV Vaccine
Most vaccines that protect against viruses generate infection-fighting proteins called antibodies that either block infection or help eliminate the virus before it can cause disease. Attempts to create a vaccine that induces antibodies that prevent HIV infection or disease, however, have so far been unsuccessful. But several recent studies suggest promising new research directions for the development of an antibody-based HIV vaccine, according to John R. Mascola, M.D., deputy director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, and colleagues.
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New York Times Examines Program To Help Orphans Survive 'Fragile Days Of Infancy'
The New York Times examines a program being offered at an orphanage in Tanzania that provides emotional and physical support for newborns and young children who are at a high risk of death after losing their mothers in infancy. "Africa is full of at least 50 million orphans, the legacy of AIDS and other diseases, war and high rates of death in pregnancy and childbirth," the newspaper writes. "With the numbers increasing every day, Africans are struggling to care for them, often in ways that differ strikingly from the traditional concept of an orphanage in the developed world."
Nutrition

Versartis Focusing On Extending Half Life Of Drugs For Metabolic And Endocrine Diseases

Versartis, Inc., a new company developing novel biologics with enhanced properties for patients with metabolic diseases, published abstracts for preclinical data on its two product candidates, VRS-859 (exenatide-rPEG) and VRS-808 (glucagon-rPEG), at the American Diabetes Association Scientific Sessions annual meeting beginning today in New Orleans. Versartis, through a unique licensing agreement with Amunix, Inc., uses the proprietary Amunix recombinant PEGylation (rPEG) technology to extend the half life of established biologics.÷  The Versartis compounds in development have the potential for significantly less frequent dosing and fewer side effects than those products currently on the market or in development. "With VRS-859, we have a product candidate that may become a "best in class" GLP-1 analog for the treatment of type 2 diabetes.÷  This compound has similar preclinical efficacy to exenatide in animal models; and the pharmacokinetics in four species support monthly dosing in humans.÷  VRS-859 can also be administered in a small volume with a small gauge needle," said Jeffrey L. Cleland, Ph.D., Founder and Chief Executive Officer of Versartis. "VRS-808 has the potential to prevent nocturnal hypoglycemia in type 1 diabetes, an unmet medical need," Dr. Cleland continued.÷  "VRS-859 and VRS-808 did not have significant toxicology at very high doses in preclinical studies, including a lack of immunogenicity in all studies.÷  We look forward to moving these products rapidly into human clinical trials to benefit diabetes patients." ABSTRACTS Exenatide: 1994-PO -- "An Extended Half-life Exenatide Construct for Weekly Administration in the Treatment of Diabetes Mellitus" The current approved regimen of exenatide for the treatment of type 2 diabetes mellitus requires administration twice a day and is effective in reducing hemoglobin A1c and body weight. Common side effects of this treatment regimen for exenatide include nausea and hypoglycemia, possibly caused by the high peak levels (Cmax) of exenatide after each injection. The ideal dosage form of exenatide would maintain the exenatide blood level in the therapeutic window for at least one week without a high Cmax, which commonly occurs with depot dosage forms. We designed an extended half-life exenatide construct that contains a long unstructured tail of hydrophilic amino acids referred to as rPEG (Exenatide-rPEG; VRS-859). The rPEG tail both increases the serum half-life and provides a slower rate of absorption, thus reducing the peak-trough ratio significantly from the levels seen with twice daily injection of unmodified exenatide. Attachment of rPEG to a model protein (26.9 kDa) increased serum half-life to 75 hrs with a 99% absolute bioavailability following subcutaneous administration in cynomolgus monkeys. A similar half-life extension is expected with exenatide, enabling weekly or every two week dosing in humans. The preclinical efficacy, pharmacokinetics, and immunogenicity of VRS-859 will be presented. The results of these studies will enable rapid progress of the construct into human clinical trials. Glucagon:÷  2001-PO -- "An Extended Half-life Glucagon Construct for the Prevention of Nocturnal Hypoglycemia" Nocturnal hypoglycemia is a common problem for type I diabetics, especially children, often leading to death. Glucagon is typically used to treat acute hypoglycemia, but the short half-life of glucagon ( Versartis


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