• Regulatory NewsRegulatory News

    Public Funds Help Late-Stage Development of About 25% of New Drugs, Study Finds

    One in four new drugs approved in the US between January 2008 and December 2017 received direct funding from public resources for late stage research or through spin-off companies created from public research institutions, a study published in the BMJ on Wednesday found.  As the drug pricing debate has accelerated in recent months, the debate over whether public or private entities do the majority of drug development work has continued, with the general assumption tha...
  • Regulatory NewsRegulatory News

    How Biopharma Companies Use NIH and Vice Versa

    An argument has been brewing on Capitol Hill and elsewhere that boils down to the theory that US taxpayers are fronting billions of dollars’ worth of public research that translates into early-stage products that are later sold to companies, go on to win FDA approval and then reap millions or billions in sales, although the government never sees a dime of those earnings. With the help of a new Congressional Research Service (CRS) report published Friday and some other m...
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    Lawmakers Urge HHS to Exercise 'March-in' Rights to Fight Higher Drug Costs

    A group of 51 lawmakers are calling on the National Institutes of Health (NIH) to issue guidance on when "march-in rights" could be used to bypass patents on drugs developed using federal funding. In a letter led by Rep. Lloyd Doggett (D-TX) to Department of Health and Human Services (HHS) Secretary Sylvia Burwell and NIH Director Francis Collins today, the lawmakers call on NIH to "utilize [its] existing statutory authority to respond to the soaring cost of pharmaceutic...
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    WTO Reviews India's Trade Policies, Including Drug Patents, Compulsory Licensing

    The World Trade Organization (WTO) is conducting its sixth review of India's trade policies this week. To coincide with the review, the WTO Secretariat has released a report on India's trade and related policies, which highlights areas of many areas of progress, while noting some areas of concern related to India's policies on drug patents. Background The WTO routinely reviews its members' trade-related policies in order to track developments that may affect global ...
  • Large Carriers Cave to Animal Rights Groups, Placing New Burdens on Preclinical Research

    • 21 September 2012
    Conducting preclinical research is likely to become even more difficult under new policies announced by major cargo carriers, reports Scientific American . FedEx and UPS, two of the world's largest shipment and logistics companies, have announced respective agreements with People for the Ethical Treatment of Animals (PETA) to prevent the shipment of mammals for use in preclinical testing. The move is likely to place additional burdens on clinical researchers, who r...