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Biosimilars Ahead, Proceed with Caution

Richard Dolinar

By Richard M. Dolinar, M.D., Chairman, Alliance for Safe Biologic Medicines In today’s budget-constrained world, the goal for health care is not only to save lives but also to save money. On Friday, May 11, the Food and Drug Administration (FDA) will hold a one-day public hearing on important medicines, known as biosimilars, that are under FDA consideration to come to the United States (U.S.) and offer the opportunity to help achieve the second prong Read More >

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Industry Regulatory Issues to be Highlighted at 2012 BIO International Convention

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In the words of BIO’s Andrew Emmett, Managing Director, Science & Regulatory Affairs, ‘2012 is shaping up to be a momentous year for FDA reform.’ From the reauthorization of the Prescription Drug User Fee Act (PDUFA V) to modernizing and expediting the approval of new drugs and biologics, implementing the new biosimilars pathways and addressing the growing global drug shortage crisis, all eyes are on the current regulatory environment and its role in supporting innovation. Read More >

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Patent-Eligible Subject Matter after Mayo v. Prometheus: Exploring the Path Forward

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Patent-Eligible Subject Matter after Mayo v. Prometheus: Exploring the Path Forward is a public round-table event hosted by the Biotechnology Industry Organization and the George Washington University Law School. Guest speakers at the round-table will discuss implementation of the Prometheus decision in patent prosecution practice, in examination guidance in the United States Patent Office, and in patent litigation.  Speakers will also discuss the implications of the decision on personalized medicine and possible ways forward.  Speakers include: The Hon. Paul Read More >

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Help Children and Adults with Brittle Bones During OI Awareness Week

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By Stuart Tart, Director of Development, Osteogenesis Imperfecta Foundation Ten years ago, Greg and wife Leigh brought their new daughter, Mallie, home from the hospital. When she was 9 days old, Mallie was fussy, leading Greg and Leigh to discover that their baby girl had fractured her right tibia and fibula.  The new parents immediately took their daughter to the doctor, who advised them to take Mallie straight to the emergency room. They discovered that Read More >

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American Invents Act Strategies Highlighted at the IPCC Conference

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By David Saravitz, Alston + Bird Day 2 of the 2012 BIO Intellectual Property Counsels’ Committee (IPCC) Spring Conference kicked off with a panel on the America Invents Act (AIA).  The panel focused on how practitioners and the U.S. Patent & Trademark Office (USPTO) are dealing with various provisions of this new patent act. Mr. Ira Finkelstein, Senior Patent Counsel with Baxter Healthcare, led off the session initially discussing the first-inventor-to-file provision of the AIA (§ Read More >

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