Patent Baristas

The U.S. Food and Drug Administration (FDA) announced new steps to strengthen existing protections against the growing problem of counterfeit drugs. The measures, which were recommended in a report by the agency’s Counterfeit Drug Task Force, emphasize certain regulatory actions and the use of new technologies for safeguarding the integrity of the U.S. drug supply. […]

The Boston Globe on ran a story on Senate Finance Committee Chair Chuck Grassley (R-Iowa) and his role as the driving force behind a congressional charge to change FDA. According to the Globe article, Grassley has “exposed internal FDA memos, emails and conversations to unprecedented public scrutiny” in his attempts to “prod the agency to […]

The U.S. Food and Drug Administration has approved Novartis AG’s Omnitrope hormone in what could mark a sea change in the stance taken by the FDA on generic biotechnology drugs. This precedent setting event marks the first follow-on version of a previously approved recombinant biotechnology drug in the U.S. Earlier, a federal judge ordered the […]

Forbes.com reports that Merck is close to obtaining approval for a vaccine against common viruses that lead to cervical cancer. An FDA advisory committee voted 13-0 to approve Merck’s Gardasil, a vaccine that protects against four types of sexually transmitted viruses– two of which are believed to be responsible for about 70% of cervical cancer […]

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires drug companies to file certain agreements with the Federal Trade Commission and the U.S. Department of Justice. The FTC’s Bureau of Competition has now issued a summary of agreements filed with the Commission in fiscal year 2005 by generic and branded drug manufacturers. The […]

A federal judge has ordered the U.S. Food and Drug Administration to decide after a long delay whether Novartis AG can market a version of human growth hormone as a bioequivalent to the one already sold by Pfizer Inc. The order by Judge Ricardo Urbina of the U.S. District Court for the District of Columbia […]

The Federal Trade Commission (FTC) is considering conducting a study to analyze the use and likely short- and long-run competitive effects of authorized generic drugs in the prescription drug marketplace. An authorized generic is chemically identical to a particular brand-name drug, but the brand-name manufacturer authorizes it to be marketed in a generic version. In […]

The Food and Drug Administration (FDA) released an initial list of priority research projects that could advance innovation in medical products. The announcement of the Critical Path Opportunities List signals the next major step in FDA’s Critical Path Initiative aimed at modernizing medical product development, so new medical discoveries are brought to patients faster and […]