Teva’s Copaxone Suit Is “Absolutely Unprecedented,” FDA Says
This article was originally published in The Pink Sheet Daily
FDA says Teva’s argument to court about dire impact of potential glatiramer ANDAs does not match its statements to investors.
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Teva’s multiple sclerosis drug Copaxone lost patent protection about three weeks ago. But according to some analysts an immediate generic substitution is still up in the air and the company has not lost the opportunity to capitalize in the interim by switching patients to a new three-injections-a-week formulation.
Wall Street is mixed on whether Teva’s newly approved three-times-weekly formulation will protect its MS blockbuster franchise.
Company expects clinical trials to begin by September and says first batches could be available for emergency use authorization in early 2021; J&J pledges vaccine will be available to public on not-for-profit basis.