Adolor and marketing partner GlaxoSmithKline's post-operative constipation therapy Entereg is the first drug to clear FDA with its highest level of Risk Evaluation and Mitigation Strategy - a required controlled distribution program. Entereg is at least the fifth new drug, and the second new molecular entity, to be approved with a REMS since the new authority granted by the FDA Amendments Act went into effect March 25
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.
The European Medicines Agency’s, human medicines committee, the CHMP, is this week poised to issue opinions on potential marketing approvals for 17 products.
The European Medicines Agency is expected to decide whether to recommend EU-wide marketing authorization for six orphan-designated medicines that are all already approved in the US.
