Tag Archives: health

Doping Undermines the Mission of Biotechnology

Sochi Flame

The Olympic Games in Sochi captures the world’s attention as athletes compete to bring home gold. Our industry plays a key role in helping to maintain the integrity and honor of sports and competition by remaining vigilant in our anti-doping efforts. Doping undermines the integrity of our industry’s core mission of serving patients through drug discovery and development. The same medicines that can be used to help children with devastating genetic deficiencies and growth disorders, Read More >

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

Jim Greenwood

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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