King/Elan deal in jeopardy?: King is "evaluating the effect" that FTC's investigation into Elan's Skelaxin will have on its proposed acquisition of Elan's primary care business. King is "evaluating what our rights are under our contract," company says at SG Cowen March 19. FTC opened an investigation into Elan's "Orange Book" patent listings for the muscle relaxant (1"The Pink Sheet" March 17, In Brief). King reiterated that it will not purchase the sleep agent Sonata as a stand-alone product. "The transaction is not structured that way." The $850 mil. deal, which has a deadline of July 31, would add 400 sales reps to King's 800-person force ("The Pink Sheet" Feb. 3, p. 29)...
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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.’
The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?
The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. However, Mark Samuels, CEO of Medicines UK, the trade body representing the off-patent industry, says companies are still face multiple hurdles in the market.
The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.
