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Updated Legal and Regulatory Frameworks Needed for Biosimilars

Jim Greenwood

Biosimilars raise novel and complex questions of science and law that require updated legal and regulatory frameworks. We call on the FDA to release final guidance on processes and scientific criteria for the approval of biosimilars, outline its approach to naming and labeling, and clarify its conditions for determining a biosimilar to be interchangeable with its reference biological. There has been positive momentum recently, however, we believe the appropriate way to develop policy on such Read More >

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Attacks on Venture Philanthropy Miss Mark Badly

Jim Greenwood

In a highly problematic op-ed in today’s New York Times, freelance journalist Llewellyn Hinkes-Jones attacked venture philanthropy and patient foundation funding of medical research, which has become a valuable source of funding for diseases which may not otherwise receive research dollars. Venture philanthropy organizations bring a singular focus and drive to the process of getting promising therapies from the laboratory bench to the patient as quickly and efficiently as possible, bringing hope – and results – to Read More >

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Wall Street Journal Highlights Promising Gene Therapy Advances

Jim Greenwood

Yesterday, bluebird bio reported some very uplifting news at the annual meeting of the American Society of Hematology. Two patients with beta-thalassemia, a genetic disorder which normally requires regular blood transfusions, have been able to forgo transfusions for at least five months following a gene therapy treatment from bluebird. The Wall Street Journal’s Ron Winslow reports: Bluebird bio’s treatment involves extracting blood stem cells from a patient, treating them with a functioning version of the defective Read More >

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Jim Greenwood Op-Ed: Time to Fund Medical Countermeasures against Threats like Ebola

Jim Greenwood

On Friday, The Hill published an op-ed from BIO President and CEO Jim Greenwood calling on Congressional appropriators to fully fund federal biodefense programs, which partner with industry to develop medical countermeasures against Ebola as well as other threats like smallpox, anthrax, and botulism toxin. President Obama’s supplemental Ebola funding request last week asked Congress to appropriate $157 million in funding for BARDA and $238 million for the National Institutes of Health to support Ebola Read More >

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Gates to contribute $50M for Ebola response

admin-ajax

Bill Gates was on MSNBC’s Morning Joe to discuss the Gates Foundation’s contribution of $50 million to support emergency response to Ebola. Mr. Gates responded to criticism that the U.S. was initially slow to properly address the African crisis. He noted that it would be virtually impossible to respond much quicker to the unprecedented scale of the outbreak. He did call upon other countries to step up and dedicate resources as well. The most recent Read More >

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