Medi-Physics' Ceretec imaging agent launch set for in mid-June for detecting infections.
• By The Pink Sheet
MEDI-PHYSICS CERETEC NEW FORMULATION WILL BE LAUNCHED at the Society of Nuclear Medicine's annual meeting June 12-15 in Minneapolis. Three improvements of the diagnostic imaging agent Ceretec (technetium Tc99m exametazime) were approved April 7 through two efficacy supplements. The new formulation of Ceretec will replace the original version that was approved by FDA in December 1988 for stroke imaging with single photon emission computed tomography, Medi-Physics said.
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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 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.