Pharmaceuticals

  • Read more: Sequenom vs. Ariosa and international approaches to the patent eligibility of biomedical innovation
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    Sequenom vs. Ariosa and international approaches to the patent eligibility of biomedical innovation

    By Timo Minssen With a potential petition for writ of certiorari in the Sequenom v. Ariosa case approaching, it appears as if the US Supreme Court  will once again have to consider crucial patent eligibility questions with a great significance for biomedical innovation and diagnostic methods. The claims at issue (see U.S. Patent No. 6,258,540 ) are directed to methods of genetic testing by detecting and…

  • Read more: Can the United States Use Mortgage-Like Loans to Pay for High Cost Drugs?
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    Can the United States Use Mortgage-Like Loans to Pay for High Cost Drugs?

    By Elizabeth Guo Pharmaceutical companies are making breakthrough drugs to cure diseases, but no one knows how to pay for them. In 2013 and 2014, FDA approved Solvaldi and Harmoni, which can cure hepatitis C in more than 90% of patients. Solvaldi and Harmoni cost $84,000 and $95,000, respectively, for a standard course of treatment….

  • Read more: FDA Announces Draft Guidance That Would Limit Enforcement Discretion for FMT
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    FDA Announces Draft Guidance That Would Limit Enforcement Discretion for FMT

    By Rachel Sachs Yesterday, the FDA announced a new draft guidance regarding its exercise of its enforcement discretion around the investigational new drug (IND) requirements as they apply to fecal microbiota transplantation, or FMT.  For almost three years now, the FDA has exercised its enforcement discretion for FMT under a rather permissive set of guidelines,…

  • Read more: Jacobus and Catalyst Continue to Race for Approval of LEMS Drug
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    Jacobus and Catalyst Continue to Race for Approval of LEMS Drug

    By Dalia Deak The latest development in the race for approval between Jacobus Pharmaceutical Company and Catalyst Pharmaceuticals is a ‘refuse to file’ letter that the FDA issued to Catalyst indicating that Catalyst’s New Drug Application for Firdapse was incomplete. Both companies are competing for approval of slightly modified forms of a drug—3,4-diaminopyridine, or 3,4-DAP—…

  • Read more: Evolving Industry Structures in Biosimilar Development
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    Evolving Industry Structures in Biosimilar Development

    By Rachel Sachs Yesterday, I had the privilege to moderate a fantastic event here at the Petrie-Flom Center on Assessing the Viability of FDA’s Biosimilars Pathway.  Bringing together expert panelists from legal practice (Donald R. Ware, Partner, Foley Hoag LLP), industry (Konstantinos Andrikopoulos, Lead IP Counsel, Manufacturing, Biogen, Inc.), and academia (W. Nicholson Price II,…

  • Read more: Why Senator Markey’s Message Hurts Children
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    Why Senator Markey’s Message Hurts Children

    By Elizabeth Guo Last week, Senator Edward Markey (D-MA) placed a hold on the Senate’s nomination of Robert Califf’s as head of the Food and Drug Administration (FDA). The move was less against Califf and more as political leverage against FDA’s approval of OxyContin. In August 2015, FDA approved OxyContin, a prescription painkiller, for pediatric…

  • Read more: TOMORROW, 1/29! Fourth Annual Health Law Year in P/Review Symposium
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    TOMORROW, 1/29! Fourth Annual Health Law Year in P/Review Symposium

    MORE SEATS AVAILABLE! Fourth Annual Health Law Year in P/Review January 29, 2016 8:00 AM – 5:00 PM Wasserstein Hall, Milstein West AB  Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA The Fourth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2015 and what to watch out for in 2016. The discussion…

  • Read more: Four Key Issues In Health Law That Are As Relevant As Ever In 2016
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    Four Key Issues In Health Law That Are As Relevant As Ever In 2016

    Petrie-Flom’s Executive Director Holly Fernandez Lynch has a new post over at the Health Affairs Blog as the first entry in a series that will stem from our Fourth Annual Health Law Year in P/Review conference, to be held at Harvard Law School on Friday, January 29, 2016. In it, Holly takes stock of which major issues in health law policy remain outstanding from years…

  • Read more: March-In Rights Alone Won’t Solve Our Drug Pricing Problems
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    March-In Rights Alone Won’t Solve Our Drug Pricing Problems

    By Rachel Sachs On Monday, a group of over 50 members of Congress sent a letter urging the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) to use a little-known statutory provision to take action against high drug prices.  Their goal is laudable, and HHS and the NIH should…

  • Read more: Peeling the Onion: How to Promote Pharmaceutical Innovation and Access to Medicine
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    Peeling the Onion: How to Promote Pharmaceutical Innovation and Access to Medicine

    By Timo Minssen As mentioned in my earlier blog post, I decided to conclude this year by publishing a introductory speech that I gave on April 14th, 2015 at the 2015 Broad Institute Innovation & Intellectual Property Symposium. The speech was part of the session “Bringing Therapies to the Patients” and introduced a panel-discussion with Entrepreneur and Professors of…