Tag Archives: health

FDA Week: For Biologics, A Name Isn’t Just A Name (Jim Greenwood op-ed)

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What is in a name? Names help make medicinal products more easily distinguishable by doctors, pharmacists and patients. When you are talking about biologics, complex medicines that are manufactured using living organisms, and biosimilars, medicines that are similar to, but not the same as, innovator biologics, naming is a significant consideration. As a pathway for biosimilars approval is implemented, a clear priority should be to craft a naming convention that both contributes to patient safety Read More >

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National Black HIV/AIDS Awareness Day

National Black HIV/AIDS Awareness Day

In the United States, more than one million people are infected with HIV, with an estimated 50,000 newly diagnosed each year. While African Americans make up only 12-14 percent of the U.S. population they account for nearly half (44 percent) of all the new HIV infections in the U.S. (CDC). Today, as the United States observes National Black HIV/AIDS Awareness Day, we’d like to take a look at some of the scientific advancements made in Read More >

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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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