FDA’s Draft Biosimilar Guidance: A Good First Step

February 27, 2012

By Richard Dolinar A key component of the Patient Protection and Affordable Care Act (PPACA) of 2010 has just been released with little fanfare. One of the most significant provisions in the law gives the Food and Drug Administration (FDA) the authority to regulate biosimilars, which are attempts to replicate some of the most complex […]

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Alliance to Host Capitol Hill Forum

February 22, 2012

Alliance to Host Capitol Hill Forum The Alliance for Safe Biologic Medicines and Bloomberg Government will host a lunchtime Biosimilars Forum on Capitol Hill this coming Monday, February 27th, 2012 to discuss the FDA’s draft guidance documents on biosimilar product development. Panelists include: Brian Rye, Health-Care Financial Analyst with Bloomberg Government (moderator) Dr. Richard Dolinar, […]

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Alliance member partner, AfPA, video on the benefits of biologics

February 15, 2012

The National Physicians Biologics Working Group today released an educational video featuring a discussion about the benefits of biologic therapies and how they differ from conventional pharmaceuticals. In the four minute video, David Charles, M.D., Chairman of the Alliance for Patient Access, discusses the importance of formulating public policies that ensure access to these biologic […]

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Alliance to host Webinar: Pharmacovigilance 101: What is it and why is it important?

February 14, 2012

The Alliance for Safe Biologic Medicines will host its third webinar on biologic and biosimilar medicines on Thursday, February 16, 2012. Click here to register! The webinar will be hosted by Alliance Chairman Dr. Richard Dolinar. Registration is free! Pharmacovigilance 101: What is it and why is it important? Thursday, February 16, 3:00 PM ET […]

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FDA issues draft guidance on biosimilar product development

February 9, 2012

The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. “When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process,” said […]

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Winning Against Cancer with Safe and Effective Treatments

January 24, 2012

By Andrew Spiegel, Chief Executive Officer of the Colon Cancer Alliance (CCA) MedCity News The marathon battle against cancer continues but we are winning. New statistics from the American Cancer Society show the number of cancer-related deaths has decreased by about 23% in men and 15% in women since 1990. These promising reductions in the […]

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Concerns linger about biotech drugs

January 4, 2012

By Helena R. Berger Florida Sun Sentinel January 4, 2012 A number of medical breakthroughs have helped individuals with severe and chronic disabilities. Many of these are biotech medicines, or biologics, which are advanced prescription drugs made from living organisms rather than chemicals. Biologics are used to treat serious disabilities like Multiple Sclerosis, Parkinson’s and […]

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Medical Innovation and Shortening the Long Goodbye

December 21, 2011

By John Horton Huffington Post Seventeen years ago, Ronald Reagan penned what some have called his “Long Goodbye”: a letter to the American people announcing that he had been diagnosed with Alzheimer’s disease. He poignantly thanked readers for allowing him to serve as president. “I only wish there was some way I could spare Nancy […]

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Regulators and doctors must work together to ensure safety of biologic medicines

December 15, 2011

By Dr. Marcy Zwelling-Aamot, chairperson of the Board of the American Academy of Private Physicians (AAPP) The Hill  The U.S. Food and Drug Administration (FDA) is holding an important public meeting today on its proposed biosimilar user fee program recommendations.  This meeting is a major step in making biosimilars available for the first time in […]

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Emerging patient safety issues under health care reform: follow-on biologics and immunogenicity

December 7, 2011

Emerging patient safety issues under health care reform: follow-on biologics and immunogenicity By Bryan A. Liang and Timothy Mackey Therapeutics and Clinical Risk Managment Abstract: US health care reform includes an abbreviated pathway for follow-on biologics, also known as biosimilars, in an effort to speed up access to these complex therapeutics. However, a key patient […]

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