Author Archives: Catherine Shaffer

The FDA Should Provisionally Approve Vascepa

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) rocked the biotech industry last week by voting 9 to 2 against approval of Amarin Pharmaceuticals Inc.’s fish-oil derived omega-3 supplement Vascepa in the supplemental indication of mixed dyslipidemia. The drug…

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Patients Take the Lead in Clinical Whole Genome Sequencing

A decade after the first human genome sequence was completed, it would probably be fair to say that whole genome sequencing is not yet ready for prime time. The problem is not the technology ‑ it’s the resulting vast quantity…

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FDA’s Confusing Action Against Burzynski – What Does it Really Mean?

Last month the FDA’s Office of Prescription Drug Promotion (OPDP) issued a warning letter to the Burzynski Research Institute Inc. and the Burzynski Clinic regarding claims made for its antineoplastons A10 and AS2-1 injections that violate the Federal Food, Drug,…

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Burzynski Institute: Patient Exploitation in the Name of Research

A cursory glance at the website of the Burzynski Research Institute Inc. turns up nothing unusual. The website showcases smiling patients and its shiny, mirror-windowed building. There’s a contact number for patients to call and a prominent “Donate” button, implying…

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