Drug licensing

Approximately 30% to 40% of currently licensed drugs are targeted at GPCRs and thus represent a highly significant source of income for many pharmaceutical companies (80). In the specific context of chemokine receptors, it is clear that they are involved in a number of prominent pathologies and thus represent an important therapeutic target (81). For example, chemokines and their receptors lie at the center of all immune and inflammatory disorders and are responsible for the aberrant accumulation of leukocytes at inflamed sites in autoimmune conditions. In addition, over the past 12 years, it has become clear... 

These plans envision assembling a portfolio of in-licensed drug candidates for which collective development risk is deemed to be relatively low. The idea is to in-license molecules that either are too specialized (small market potential) for large pharma or are not visible to their radar because they come from places like Eastern Europe. These stories are favorites of professional investors, because rNPVs can be calculated with relatively low development risk on the basis of demonstrated clinical utility and/or pipeline diversity. Examples include Dura Pharmaceuticals, who marketed prescription products that treat infectious and respiratory diseases, and Gilead who marketed antiviral nucleotides discovered in the Czech Republic. 

B. G. Winchester, Iminosugars From botanical curiosities to licensed drugs, Tetrahedron ... 

Three factors—ease of use, recordkeeping, and acceptance by military personnel and the wider public—underline the importance of licensed drugs. By contrast, the regulatory requirements of IND use, the burden of recordkeeping, and the limited public acceptance (and even rejection) highlight their limits ... 

Licensed drugs are easy to use. Decisions to use them are medical decisions, made by field commanders acting on the advice of their field surgeons, and they are administered by medical personnel. INDs, however, are far more difficult to use They may be used under all the restrictions of IND use, including informed... 

Recordkeeping for the use of licensed drugs is a routine part of medical care of deployed troops. By contrast, recordkeeping requirements for IND use are substantial. Failure to comply with FDA requirements for keeping adequate records characterized the use of INDs in the Gulf War, as it did in the use of the tick-home encephalitis vaccine in Bosnia. 

We recommend first that DoD consolidate authority for all its relationships with FDA related to drugs and biologies for CBW defense into a single OSD office. The two candidates for this responsibility are the ASD(HA) and the DATSD(CBD). Health Affairs lacks authority for research and development and acquisition it is therefore a poor candidate for being the primary OSD point of contact with FDA on acquisition-related issues. The primary FDA-related function of ASD(HA) for CBW defense is to determine the medical indications of use, both for licensed drugs and IND-classified drugs. Therefore, we conclude that Health Affairs should remain the primary OSD authority for this purpose. Moreover, it would encounter an institutional... 

Bioavailability studies using animals are used to compare the efficiency of the delivery of the dosage forms of a drug to the general circulatory system as well as the efficiency of the route of administration for both licensed drugs and new drugs under development. Two useful measurements are relative and absolute bioavailability. 

Applicants must provide information on any patent (s) on the product for which approval is sought or on a method of using the product. Such information is included in the Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations). All approved (licensed) drug products are listed in this book. 

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