From the FDA page on the Orphan Drug Tax Credit. Incentives TAX CREDIT (See Footnote 1 below) FOR TESTING EXPENSES FOR DRUGS FOR RARE DISEASES OR CONDITIONS Introduction Section 45C of the Internal Revenue Code of 1954 allows a credit… Continue Reading
From the FDA page on the Orphan Drug Tax Credit.
IncentivesTAX CREDIT
(See Footnote 1 below)
FOR TESTING EXPENSES FOR
DRUGS FOR RARE DISEASES OR CONDITIONSIntroduction
Section 45C of the Internal Revenue Code of 1954 allows a credit against tax, up to 50 percent of certain clinical testing expenses related to the use of a drug for a rare disease or condition after it is designated as an orphan drug.Notes on the 2004 to 2009 United States Food and Drug Administration Approval of New Molecular Entities (NMEs)
(Cite as Molly Redfield Ward, Notes on the 2004 to 2009 United States Food and Drug Administration Approval of New Molecular Entities (NMEs), KEI Research Note 2010:3) A PDF version of this document is available here. Notes on the 2004… Continue Reading
Notes and data points for prices of orphan products
February 22, 2010., Matthew Herper, “The World’s Most Expensive Drugs,” Forbes. Genzyme’s web page on the cost of treatment. Some data points on Fabrazyme prices. 2004 prices for Replagal 2001 prices for Cerezyme. Myozyme/Lumizyme A 2007 Canadian analysis of (50… Continue Reading
Written submission U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Hearing on Treating Rare and Neglected Pediatric Diseases: Promoting the Development of New Treatments and Cures
Written submission U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Hearing on Treating Rare and Neglected Pediatric Diseases: Promoting the Development of New Treatments and Cures, On the topic of Direct funding, subsidies and incentives for the development… Continue Reading
Transparency, cost benefit analysis and de-linkage of cost of R&D from price of the products for Rare and Neglected Pediatric Diseases
Written submission U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Hearing on Treating Rare and Neglected Pediatric Diseases: Promoting the Development of New Treatments and Cures On the topic of Transparency, cost benefit analysis and de-linkage of cost… Continue Reading
2010 Fabrazyme March-In Request
NIH rejects Fabrazyme March-In Petition
- December 7, 2010. Press release from Fabry patients: DHHS denies patient’s march-in request to end Genzyme’s rationing of treatment for Fabry Disease citing that FDA rules block manufactures from supplying the drug in a timely manner.
- December 7, 2010. Statements by KEI and others on NIH rejection of Fabrazyme March-In Request
Statutes mentioned in 35 USC 210 of the Bayh-Dole Act
When the Bayh-Dole Act was passed in 1980, it included a provision that identified 21 statutes over which the Act would take precedence. I have reordered them according to dates they appear to have been enacted, and provided some details of the referenced statutes.
35 U.S.C. 210 Precedence of chapter.
Misc Intellectual Property Limitations and Exceptions
Copyright Limitations
2 U.S.C. 170 – American Television and Radio Archives
(c) Liability for copyright infringement by Librarian or any employee of Librarian.
Continue ReadingGeneva workshop on ACTA, June 28, 2010
On June 28, 2010, Knowledge Ecology International (KEI) and IQsensato are co-hosting a workshop on the Anti-Counterfeiting Trade Agreement (ACTA).
The Location of the meeting is the Maison des Associations, on Rue des Savoises 15, Geneva, in the Salle Gandhi.
Speakers
- Carlos Correa, University of Buenos Aires
- Erik Josefsson, Adviser, Greens/EFA-European Parliament
- James Love, Knowledge Ecology International (KEI)