Tag Archives: congress

Biosimilars at the Federal Circuit – Can the Parties Be Compelled to Dance?

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In 2009, Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”), which for the first time provided for biosimilar or interchangeable biological drug products.  But it was not until March 6, 2015, that the FDA approved the first biosimilar application – an application by Sandoz to market a version of Amgen’s NEUPOGEN® (filgrastrim) biologic drug product.  Nevertheless, there is still a question as to when Sandoz will be able to begin selling its drug product, Read More >

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BIO Coalition Submits Patent Reform Letter to Congress

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BIO, alongside a coalition of patent holders and inventors, submitted a letter to the chairmen and ranking members of the House and Senate Judiciary Committees on December 10 regarding potential changes to the patent system. The coalition thanked members of the committee for their work to develop reforms which would prevent harmful patent enforcement practices, and once again reiterated their opposition to any legislation that would weaken the overall patent system. They also asked that Read More >

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House Ag Subcommittee Considers the Societal Benefits of Biotechnology

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“Organic farmers do not need to demonize conventional farmers, we are one agriculture,” opened Ranking Member. Kurt Schrader (OR-05). On July 9, 2014 at 10:00am, the House Committee on Agriculture, Subcommittee on Horticulture, Research, Biotechnology, and Foreign Agriculture held a public hearing “To consider the societal benefits of biotechnology”. Witnesses included: Dr. David Just, Professor, Co-Director, Cornell Center for Behavioral Economics in Child Nutrition Programs, Charles H. Dyson School of Applied Economics and Management, Cornell University, Ithaca, Read More >

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IPAB: Bad Medicine for Patient Care

DC in Fall

The Independent Payment Advisory Board is bad medicine for patient care, deficit reduction and containing Medicare costs. This board, consisting of 15 bureaucrats appointed by the President, has been given the power to make decisions affecting patients’ quality of care, with almost no oversight and no means for challenging its decisions. IPAB must be repealed. There is widespread support among patient advocacy groups and members of Congress on both sides of the aisle for full Read More >

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The Pivotal Role the Public Market Plays in Financing R&D

KennethMoch-Chimerix

Growing innovators are the heart of our industry. Biotech small businesses face a dual struggle – the daily challenge of running a growing company combined with the roadblocks intrinsic to groundbreaking scientific advancement. Innovative companies must overcome capital formation barriers in order to fund their next generation R&D.  The financing challenges that emerging biotechs face are unique, but we have the potential to save lives and treat patients in desperate need of hope. Today, I Read More >

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