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Cancer Insurance Checklist: Guía de Cobertura Médica para Personas con Cáncer

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As the world marks World Cancer Day and the U.S. continues to implement the Affordable Care Act, the Cancer Support Community (CSC) is pleased to announce the launch of a Spanish language version of the successful resource, the Cancer Insurance Checklist. This easy-to-use guide is available to assist people with cancer, a history of cancer or at risk for cancer choose a health insurance plan. The need is great.  Nearly a third (31.1 percent) of Read More >

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BIO Responds to GPhA Citizen Petition on Biosimilars Naming

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Last September, the Generic Pharmaceutical Association (GPhA) filed a Citizen Petition with the FDA, requesting the FDA to “implement its INN naming policy equally to all biologics” and to require “all biologics approved under the Section 351(k) pathway…share the same INN [International Nonproprietary Name] as the RPP [reference protein product]” (the GPhA Petition). Today, BIO submitted our response. Contrary to the GPhA Petition, BIO believes that the legal, regulatory, and scientific principles related to biologics and biosimilarity Read More >

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Life Science Leader on TransCelerate’s Efforts to Modernize Drug Development

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Life Science Leader’s Rob Wright has a great profile on TransCelerate BioPharma and their efforts to modernize the drug development and clinical trial landscape. TransCelerate is a nonprofit organization made up of 18 innovate biopharmaceutical companies dedicated to collaborating across the industry to find ways to simplify and accelerate the discovery of new medicines. As the article notes, the challenge involved is enormous: With combined annual revenues in excess of $300 billion and nearly 800,000 employees Read More >

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2013 Novel Drug Approvals

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The FDA approved 24 novel drugs last year by our count, in line with average approvals for the last ten years but down from the decade-high approvals seen in 2012. Our count is a bit lower than the FDA’s count of 27 new approvals, because we did not include imaging agents like Navidea’s Lymphoseek, or reformulations like J&J’s Simponi Aria. 2013 was the first year the breakthrough-designated therapies were approved, with three breakthrough therapies approved: Gilead’s Read More >

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IPAB: Bad Medicine for Patient Care

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The Independent Payment Advisory Board is bad medicine for patient care, deficit reduction and containing Medicare costs. This board, consisting of 15 bureaucrats appointed by the President, has been given the power to make decisions affecting patients’ quality of care, with almost no oversight and no means for challenging its decisions. IPAB must be repealed. There is widespread support among patient advocacy groups and members of Congress on both sides of the aisle for full Read More >

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