Tag Archives: Biologics

Data Exclusivity Protects Innovators and Assures Investors

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Biotechnology companies must have some certainty that they can protect their investment in the development of new breakthrough therapies for a substantial period of time. This protection helps companies secure much-needed venture capital funding, which is the lifeblood of the industry. A failure to include substantial data exclusivity would undermine incentives to invest in biomedical innovation and thus would slow progress in the development of breakthrough therapies to improve the health and lives of patients Read More >

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Reviewing the drug class of 2011

The drug class of 2011 was larger than the past few graduating classes. We count over 30 new “innovative” drugs found among the list of FDA approvals last year. This is in contrast to the 20-something range of the past few years. On the list are some clear breakthrough treatments and a few glimpses of “the future of biotech”. The specific drugs are listed further below, but first a big picture view: Ten of the approvals were for biologics, Read More >

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Breast Cancer and Biotechnology: Bigger Than Pink

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By David Welch, President/Senior Producer at M2 MultiMedia It had been five years since I produced Biotechnology: Knowledge Serving Life, a video that featured breast cancer patient Lori Lober and her then five year anniversary of being cancer free.  Diagnosed with Stage IV metastatic breast cancer in 2000 Lori had been admitted to an advanced clinical trial for a promising new biologic. Today, Lori credits her treatment for helping to save her life. During the Read More >

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Data Protection, Trans Pacific Partnership, and the US-Jordan FTA (Post 2 of 2)

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This post is a continuation of a previous post: Data Protection, the Trans Pacific Partnership, and the US-Jordan FTA (Post 1 of 2). 4.  Oxfam criticizes pharmaceutical innovators for not making all of their innovative drugs available in Jordan. Ryan responds: a.  Innovator companies introduced few new drugs before IP reform because local companies were using their know-how and clinical data to get marketing approval and brochures describing the drug’s therapeutic function and side effects Read More >

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Huffington Post: Data Exclusivity: Getting the Balance Right

Huffington Post: Data Exclusivity: Getting the Balance Right      A great article on the downsides of cutting or removing data exclusivity provisions for biologics.  The article points out that data protection is needed to enhance safety and create incentives to research and produce new innovative drugs that cost billions of dollars.  However, the author argues that the period must be limited somehow (not 50 years) to ensure generics can entire the market and lower costs.    Finally, the author states that lowering the data exclusivity Read More >

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