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News Breaks
January 29, 2014
07:14 EDTDEPO, MNKFDA PDUFA Date for Depomed/Mallinckrodt MNK-795 is January 29, 2014
News For DEPO;MNK From The Last 14 Days
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September 17, 2014
16:18 EDTDEPODepomed says FDA recognizing 7 years orphan-drug exclusivity for Gralise in PHN
Depomed (DEPO) disclosed in a filing that on September 16 the company received a letter from the FDA informing the company that pursuant to the order issued on September 5 by a judge of the U.S. District Court for the District of Columbia, the FDA is recognizing seven years of orphan-drug exclusive approval for the company’s Gralise for the management of postherpetic neuralgia. The letter also confirms the FDA will not approve any abbreviated New Drug Application referencing Gralise during the period of orphan-drug exclusive approval, which began on January 28, 2011. The FDA has 60 days after issuance of the order in Depomed, Inc. v. HHS to file a notice appealing the order to the United States Court of Appeals for the Federal Circuit. The period of orphan drug exclusivity applicable to Gralise for PHN is separate from marketing exclusivity arising from the previously disclosed decision issued on August 19 in the company’s patent litigation lawsuit against Actavis (ACT) related to an ANDA filed by Actavis seeking to market generic versions of Gralise. The decision found that Actavis infringed all seven of the company’s patents asserted in the litigation, upheld the validity of the patents and enjoined FDA approval of the Actavis ANDA until February 26, 2024, the latest expiration date of the infringed patents. On September 15, Actavis filed a notice appealing the decision to the United States Court of Appeals for the Federal Circuit, Depomed stated. Previously disclosed settlement agreements between the Company and two other Gralise ANDA filers permit the sale of generic Gralise beginning on January 1, 2024.
September 16, 2014
07:30 EDTMNKCRT Capital to hold a conference
2nd Annual Investor Conference to be held in Greenwich, CT on September 16.
September 5, 2014
14:36 EDTDEPODepomed summary judgement motion granted in Gralise suit against FDA
Depomed announced that Judge Kentaji Brown Jackson of the federal district court for the District of Columbia has granted Depomed's motion for summary judgment in the company's lawsuit against the FDA seeking an order requiring the FDA to grant Gralise Orphan Drug exclusivity for the management of postherpetic neuralgia. The court's ruling requires that the FDA grant Orphan Drug exclusivity for Gralise for the management of PHN.
September 4, 2014
09:02 EDTMNKMallinckrodt announces MNK-155 Phase 3 efficacy trial met primary endpoint
Mallinckrodt reported that a Phase 3 efficacy trial of investigational MNK-155 met the study’s primary endpoint of improved pain scores vs. placebo over the first 48 hours following bunionectomy. This difference in pain scores was statistically significant in favor of MNK-155. The data is being presented at PAINWeek 2014 on September 2-6. In addition to the Phase 3 study, Mallinckrodt will present data at PAINWeek from several other MNK-155 trials, including the pharmacokinetics, safety and subjective effects of abuse-related characteristics.

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