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India’s top drug regulatory body plans to fast-track approvals for combination products recommended by the World Health Organization to treat HIV and hepatitis B and C. Read More
The European Medicines Agency has expanded the types of documents it will publish alongside clinical study reports from sponsors’ drug product applications. Read More
Research heads of 19 global pharmaceutical companies signed on to an open letter calling for a quick decision to relocate the European Medicines Agency from London, post-Brexit — preferably at the June meeting of the European Council. Read More
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