Tag Archives: FDA

Mito What???

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Mitochondrial Disease: The Most Common Disease You’ve Probably Never Heard of… About 20 years ago, mitochondrial disease was virtually unheard of.  Just 10 years ago, it was considered rare. Today, according to NORD, a disease is considered rare when less than 200,000 people are affected.  Mitochondrial disease is not a single disease, but rather an entire umbrella of rare diseases.  For example, Alpers disease and Barth syndrome are very different and rare forms of mitochondrial Read More >

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Tekmira Pharmaceuticals Ebola Drug Gets Nod From FDA

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The U.S. Food and Drug Administration has authorized Canada’s Tekmira Pharmaceuticals to provide an experimental drug to people with confirmed or suspected Ebola virus infections, according to an article in The Wall Street Journal. “Our TKM-Ebola drug supplies are limited, but we will continue to help where we can,” Tekmira Chief Executive Mark J. Murray said in a press release. The drug is still in clinical testing to assess whether it is safe and effective. BIO Read More >

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Patients Suffering from Gaucher’s Disease Deserve Better

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Gaucher Disease is one of the over 6,000 rare diseases that affect patients worldwide, representing a frontier of unmet medical need [NCATS, NIH]. The challenges for drug development generally—long and costly research and development timelines—are exacerbated by the inherently small patient populations affected by rare diseases. These patients can be difficult to identify and geographically dispersed and their clinical presentation can be quite disparate, complicating the design and recruitment for clinical trials used to determine Read More >

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Pro-GMO Labeling Business Faces Own Labeling Dilemma

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 “Dr. Bronner’s should spend more time worrying about their own labels.” The Center for Consumer Freedom recently published an interesting piece on Dr. Bronner’s Magic Soaps and his run in with the FDA.  You may know that Dr. Bronner’s Magic Soaps is an outspoken advocate of the scientifically suspect “GMO labeling” movement.  In a warning letter to the company, the FDA states: “Based on our review of the product label, we have determined that your product is promoted for conditions that Read More >

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Docs to FDA: Biosimilars should have different names than branded drugs

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Yesterday, Fierce Biotech highlighted a letter written by more than 10 medical associations and 20 individual specialists to FDA Commissioner Margaret Hamburg saying that biosimilars “must have distinguishable nonproprietary names. The FDA drafted a set of rules for biosimilars in 2012, sparking a debate on whether those drugs should carry the same generic names as the originator products. Now, some doctors are weighing in on the issue, urging the FDA to require biosimilars to have distinguishable names. The physicians argued that using different Read More >

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