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Health care practitioners are more frequently using laboratory developed tests (LDTs) to diagnose and predict the risk of developing a disease, as well as to inform decisions on disease state management such as for cancer, heart disease and diabetes. As practitioners become increasingly reliant on diagnostic tests to guide important treatment decisions, concerns about the efficacy and safety of new LDTs have simultaneously arisen. As a result, regulatory safeguards that can ensure LDTs’ accuracy are…
On August 24, 2015, the Patent Trial and Appeal Board (PTAB) declined institution of two petitions filed by Coalition For Affordable Drugs for Inter Partes Reviews (IPRs) of Acorda’s patents (U.S. Patent Nos: 8,007,826, 8,663,685) covering Ampyra, a billion-dollar drug for treating multiple sclerosis. Coalition For Affordable Drugs – Petitioner The Petitioner, Coalition For Affordable Drugs, is a wholly owned subsidiary of a hedge fund managed by Kyle Bass, which appears to have little to do with…