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Sponsors should include clear assessments of necessary future actions in their periodic safety update reports, not simply provide a list of adverse events, according to new guidance from the European Medicines Agency. Read More
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