Tag Archives: FDA

FDA Commissioner Califf to Industry at #BIO2016: Talk to Patients

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Industry should work with patients and their advocates to better understand their experiences, what they’re looking for in a therapy, and their tolerance for risk, US Food and Drug Administration commissioner Robert Califf emphasized during a fireside chat at the BIO International Convention this afternoon. For the past few years FDA has been meeting with patients and patient advocates to better understand their diseases and medical problems and asking them where regulatory efforts should be Read More >

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Orphan Drug Tax Credit is Crucial to Rare Disease R&D

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The term “rare disease” may be misleading: to be “rare” a disease must effect fewer than 200,000 people in the U.S., but there are over 7,000 rare diseases that have been identified. Taken together, that means that nearly 30 million Americans suffer from a rare disease or condition.  While innovative therapies have been developed for a variety of these diseases—including Sickle Cell Anemia, Gaucher Disease, and Huntington Disease—too many patients still lack treatment options. Developing Read More >

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2015 FDA Approvals: Highest Levels in Over a Decade

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2015 was a blockbuster year for FDA approvals of novel new medicines, many of them for serious and life-threatening conditions. As Dr. John Jenkins of the FDA’s Center for Drug Evaluation and Research (CDER) notes in a recent blog post, “During this past year, we approved many new drugs to treat various forms of cancer, including four to treat multiple myeloma, and others to treat lung, skin, breast, brain, colorectal, and other cancers. We also Read More >

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The March of Genetic Food Progress

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You may already be familiar with Julie Kelly’s contributions to the Genetic Literacy Project but you may not know that she is a cooking instructor and food writer in Orland Park, Illinois. The Wall Street Journal recently published an opinion piece by Julie Kelly on how ‘Farmaceuticals’ and other GM products are slowly being approved, despite political scare campaigns. Ms. Kelly’s piece does a great job of arguing how genetic engineering has gradually overcome fear-mongering and false misrepresentation from those who Read More >

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“Please Wait a Few Moments While Your Pill Prints”

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Since the late 1980’s, innovators have dreamed of living in a world where science could develop anything they want simply by pressing “print.” 3D printing has evolved to create an array of medical applications from prosthetics to printed bones and tissues, and now—3D printed pills. Three days ago, the Food and Drug Administration approved Spritam, the first 3D-printed drug expected to hit the market by early 2016. It was developed by Ohio based Aprecia Pharmaceuticals Read More >

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