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News Breaks
June 26, 2014
08:42 EDTIG, MNKMallinckrodt grants IGI Labs non-exclusive license to launch generic PENNSAID
IGI Laboratories (IG) announced that it has entered into an agreement with Mallinckrodt (MNK) and Nuvo Research to settle a declaratory judgment action brought by IGI, concerning IGI's filing of an abbreviated new drug application with the FDA seeking approval to market a generic version of PENNSAID 1.5% w/w. Under the terms of this agreement, Mallinckrodt granted IGI a non-exclusive license to launch its diclofenac sodium topical solution 1.5% product on March 28, 2015. IGI received tentative approval of its diclofenac sodium topical solution 1.5% from the FDA on May 7. IGI CEO Jason Grenfell-Gardner said, "The agreement provides IGI with a date certain launch of diclofenac sodium topical solution 1.5%. We remain confident in our ability to obtain final FDA approval of our ANDA for diclofenac sodium topical solution 1.5% prior to our agreed upon launch date. The agreement allows IGI to continue to expand its portfolio of generic topical prescription drug products."
News For IG;MNK From The Last 14 Days
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September 16, 2014
09:06 EDTIGIGI Laboratories price target raised to $10 from $7.50 at Craig-Hallum
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07:30 EDTMNKCRT Capital to hold a conference
2nd Annual Investor Conference to be held in Greenwich, CT on September 16.
September 8, 2014
09:23 EDTIGIGI Laboratories price target raised to $9 from $7.25 at Roth Capital
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September 5, 2014
20:38 EDTIGIGI Laboratories management to meet with Craig-Hallum
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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.
September 3, 2014
09:07 EDTMNKMallinckrodt reported MNK-155 HAL study data
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07:53 EDTMNKMallinckrodt management to meet with Deutsche Bank
Meeting to be held in New York on September 3 hosted by Deutsche Bank.

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