Category Archives: Corporate

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The Value of Innovation to Save and Transform Lives

lab_tech

Patients have greater hope for cures to today’s most complex and challenging diseases thanks to modern specialty medicines, which allow doctors and patients to focus on prevention and avoid hospital care altogether. With the potential to save countless lives and improve so many more, today’s innovative life-enhancing medicines and therapies provide economic value far beyond their cost. The debate surrounding the value of modern specialty medicines focuses narrowly on one aspect – cost – while Read More >

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When The Deck is Stacked Against Innovators, Everyone Loses

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Yesterday, I took part in a series of successful meetings on Capitol Hill regarding the USPTO’s Inter Partes Review system (IPR). Joined by several of BIO’s member companies, we expressed our concerns with how the system is evolving into one which makes it easier for IPR challengers to win than in Federal Court. The implementation of the IPR system – developed through the 2011 America Invests Act – has unintentionally invited abuses of the USPTO Read More >

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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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