The Food and Drug Administration (FDA or Agency) is withdrawing approval of 29 new drug applications (NDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Shionogi Divests and exclusively licenses its paediatric products to Concordia Pharmaceuticals Inc
Concordia and Actavis UK stand accused of breaking UK competition law by artificially lifting the cost of hydrocortisone tablets to the National Health Service with a deal that delayed competition to the drug.
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Private companies have been taking advantage of climbing prices by buying older drugs on the cheap, hiking their stickers, and reselling them, Bloomberg reports, citing data from software company Connecture.
Concordia didn’t give a reason for the switch, noting only that Thompson and the board agreed that “this would be the ideal time for a leadership change.” But he’s not the only chief exec to exit his role in what’s been a tricky year for specialty drugmakers, Concordia included.
Second quarter 2016 revenue of $231.7 million, an increase of 1.4 per cent over the first quarter of 2016 and 208 per cent over the second quarter of 2015 nReported second quarter GAAP net loss of $570.5 million, GAAP earnings per share loss of $11.18, which was primarily due to an adjustment to the carrying values of Nilandron® and Plaquenil® by $567 million due to generic competitionnSecond quarter 2016 adjusted EBITDA1 of $142.3 million and adjusted earnings per share of $1.38
The biggest disaster for Wall Street in the past year was Valeant Pharmaceuticals, the drug company whose stock has lost about 90% of its value since October.
The pharmacy benefits manager slapped aside 35 more drugs in its aggressive 2017 formulary, bringing its list of barred meds to 131. Almost one-third of those additions are meds whose prices went up dramatically in recent months.
Concordia can add trouble with a short seller to the list of things it wishes it didn’t share in common with Valeant Pharmaceuticals.