Tag Archives: health

State Legislation Needed For Substitution of Interchangeable Biologics

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A great deal of the media coverage relating to California’s Senate Bill 598  neglects to mention a key issue in the biosimilars debate. This bill – or legislation similar to it – is essential to allow for the eventual substitution of interchangeable biologic therapies in the state of California. State laws governing prescription drug substitution were written before the advent of biosimilars and do not take the complexity of biologics into account. California, along with Read More >

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New FDA Final Guidance on Clinical Trial Institutional Review Boards

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On Tuesday, August 27th, the FDA finalized its Guidance for Institutional Review Boards, Clinical Investigators and Sponsors on Institutional Review Board Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an Investigational New Drug/Investigational Device Exemption is Needed.  In an article published earlier today, the Pink Sheet’s Sarah Karlin summarized the goals of this guidance as strengthening human subject protection during clinical research and increasing the efficiency of Read More >

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Involving Patients in the Research Process

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According to the National Psoriasis Foundation, as many as 7.5 million Americans live with psoriasis, making it the most common autoimmune disease in the country. More than just a skin condition, psoriasis puts people at increased risk for other serious diseases such as heart disease, diabetes and depression. Up to 30 percent of people with psoriasis develop psoriatic arthritis, an inflammatory joint disease. A complex disease with a genetic component, psoriasis is not contagious. While Read More >

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How the Orphan Drug Tax Credit Leverages MDA’s Fight against Rare Genetic Diseases

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In the early 1950s, a small group of concerned parents, people with muscular dystrophy and their friends started a volunteer organization, the Muscular Dystrophy Association (MDA), to raise money for research into the causes of rare genetic diseases that mysteriously destroyed muscles and shortened lives. In the decades since — thanks to the support of a caring public and vital corporate partnerships — MDA has become a leading voluntary health agency, funding research in academic Read More >

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Amid Doping Scandals, Industry Must Remain Vigilant

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As doping in sport makes its way back into the news of the day, we must consider the consequences beyond undermining the integrity and honor of sports and competition. Doping undermines the integrity of our industry’s core mission of serving patients through drug discovery and development. Biologic products intended for use as medicines can enhance endurance, minimize recovery time, or promote muscle growth. The same medicines that can be used to help children with devastating Read More >

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