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Ninety percent of counterfeit pharmaceuticals seized at the U.S. border in fiscal 2016 were shipped through China, Hong Kong, India, or Singapore. Read More
An FDA workshop on opioids is going ahead today despite concerns from Sen. Ron Wyden (D-Ore.) that some panelists at the conference on pain management are too closely tied to the opioid industry. Read More
The PTO’s Patent Trial and Appeal Board upheld Shire’s patent claims — following a challenge from Green Cross — over methods for the manufacture of Elaprase (idursulfase), an enzyme replacement therapy for Hunter syndrome. Read More
The Maryland state legislature approved a bill to ban excessive price increases for generics and off-patent drugs, sending it to the state’s governor for final approval. Read More
In a Senate committee markup scheduled for May 10, lawmakers will consider the next generation of the FDA’s generic user fee program, using dollar amounts negotiated over the last two years with industry. Read More
The FDA’s proposed plan for spending the $500 million allocated by the 21st Century Cures Act through fiscal 2025 prioritizes patient-focused drug development, qualification of biomarkers, and the use of real-world evidence. Read More