Category Archives: Public Policy

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Complexities of Rare Diseases Take the Spotlight at BIO

Orphan Drugs

Global Genes Founder & CEO Nicole Boice opened the BIO 2015 Orphan & Rare Disease Track by addressing a packed session with a simple, powerful statement: “We’re all working to eliminate the challenges of rare diseases, but patients and their advocates aren’t always equipped to fight.” Organizations like Global Genes help families affected by rare disease by connecting them with much needed tools and resources. By better understanding the definition of a “rare” disease, industry Read More >

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Outdated Payments Systems Aren’t Keeping Pace With Medical Innovation

Ensuring Patient Access to Innovative Medicine

We are experiencing an era of rapid medical progress thanks to the accelerated pace at which new breakthroughs are being uncovered. The compression in time between research and the creation of new treatments is a triumph for patients but a challenge for our outdated healthcare delivery system. Our payment systems were constructed to finance medical costs that increased at predictable rates but are now outdated because of the breakthrough medical advances constantly being made. The Read More >

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

Williams-headshot

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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Sen Menendez Asks SEC to Investigate IPR Abuses

Securities and Exchange Commission

New Jersey Senator Bob Menendez has asked the Securities and Exchange Commissioner (SEC) to investigate a new investment scheme designed to manipulate the stock prices of companies engaged in research and development of innovative medical therapies, to determine if the practice is illegal. As reported in this Bloomberg Business article, certain investment firms are shorting the stocks of patent-dependent life sciences companies and then using new patent litigation procedures to challenge their patents and drive Read More >

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Time: How to Breathe New Life Into America’s Health-Care System

21st Century Cures Act

Last week, Rep. Fred Upton (R-MI) published an op-ed – How to Breathe New Life Into America’s Health-Care System – in Time Magazine on the potential of the 21st Century Cures Act to ‘help modernize the health-care innovation infrastructure, incorporate a patient perspective into the drug and device approval process, support advances in personalized medicine, streamline clinical trials, and provide more resources to support cutting-edge research and help young scientists.’ Rep. Upton points out that there are Read More >

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