The trials and tribulations of doing drug research in children
- Untitled. // BioWorld Today;1/8/2014, Vol. 25 Issue 5, p10
The article reports on 3.58 million U.S. dollars in second round funding secured by biopharmaceutical firm from new and existing investors as of January 8, 2014 which will be used to move the firm's antibody-carbohydrate mabxcite conjugates toward an investigational new drug application filing.
- Genervon Wages Fight to Accelerate the Drug Approval Process. // Chain Drug Review;4/27/2015, Vol. 37 Issue 7, p247
The article reports on the effort of Genervon Biopharmaceuticals LLC to improve the regulatory process for new-drug approvals with an experimental amyotrophic lateral sclerosis (ALS) drug and patients who suffer from the progressive neurodegenerative disease.
- Part II: Implementation of Pharmacokinetic Principles in Pediatric Psychopharmacology. Engle, Krista; Tran, Heather; Robb, Adelaide S. // Child & Adolescent Psychopharmacology News;Aug2015, Vol. 20 Issue 4, p1
The article focuses on application of pharmacokinetic principles in pediatric psychopharmacology dealing with topics like approval of antidepressants by Food and Drug Administration, randomized, placebo-controlled trials (RPCTs) for antidepressant drugs, and use of pediatric pharmacokinetic data...
- Evaluation of Cefaclor in Acute Otitis Media Caused by Ampicillin-resistant H. influenzae. Schwartz, Richard H.; Rodriguez, William J.; Khan, Waheed N.; Brigham, Lori; Ross, Sydney // Clinical Pediatrics;Jul1982, Vol. 21 Issue 7, p402
Cefaclor was used to treat 13 children with acute otitis media caused by ampicillin-resistant strains of Hemophilus influenzae. The children were re-examined on days 4, 10, and 28. Pharmacologic compliance was assessed by means of a bioinhibition assay on a urine specimen obtained on days 4, 7,...
- Treatment of Giardiasis. Lerman, Stephen J.; Walker, Richard A. // Clinical Pediatrics;Jul1982, Vol. 21 Issue 7, p409
Giardia lamblia has emerged as the most common intestinal parasite in the United States. This article presents a brief review of the clinically important aspects of giardiasis and evaluates the currently used therapeutic agents. Three drugs have been advocated for the treatment of giardiasis:...
- Ablynx, Galapagos Announce Big Ambitions for This Year. O'Donnell, Peter // BioWorld International;3/5/2008, Vol. 13 Issue 10, p4
This article reports on some of the projects of the Belgian biotechnology company Ablynx. The company aims to start Phase II development of its ALX-0081 anti-thrombotic agent. It has initiated a program to develop a subcutaneous delivery form of the product. Ablynx also plans to file an...
- Taiwan revamps pharma legs. // R&D Magazine;Mar2007, Vol. 49 Issue 3, p18
The article deals with the plan of the Science and Technology Advisory Board of Taiwan to reduce the time and process steps required by the Department of Health for a new drug application. The policy eliminates the second-step investigation and approval by the agency's Drug Review Board....
- Faster reviews increase risks: study. // Medical Marketing & Media;Dec2013, Vol. 48 Issue 12, p28
The article presents a research study of 20 approved drugs by the U.S. Food and Drug Administration (FDA) in 2008 which shows the need for further systematic assessment of the procedures and standards for testing new drugs.
- IL-1 trap go-ahead. Ratner, Mark // Nature Biotechnology;May2008, Vol. 26 Issue 5, p485
This article reports on the market authorization of Arcalyst, the first drug based on Trap technology. Trap technology involves the fusing of two receptor components and an Fc antibody molecule. Arcalyst is a treatment for cryopyrin-associated periodic syndromes (CAPS), which are hereditary...