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August 6, 2014
17:46 EDTMNKMallinckrodt announces settlement of Ofirmev injection patent litigation
Mallinckrodt announced that its subsidiary, Cadence Pharmaceuticals, has entered into settlement and license agreements with Fresenius Kabi USA resolving pending patent litigation involving Ofirmev injection. The companies are not disclosing specific terms of the settlement and license agreements, except that Cadence has granted Fresenius Kabi a non-exclusive right to market an intravenous acetaminophen product in the U.S. under Fresenius Kabiís NDA on December 6, 2020, or earlier under certain circumstances. Mallinckrodtís subsidiary Cadence has two patents covering Ofirmev listed in the Orange Book, the last of which will expire on June 6, 2021. Cadence had filed suit against Fresenius Kabi in January 2013.
News For MNK From The Last 14 Days
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November 24, 2015
10:25 EDTMNKOptions with decreasing implied volatility
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08:46 EDTMNKMallinckrodt price target lowered to $82 from $97 at Leerink
Leerink analyst Jason Gerberry says Mallinckrodt reported a strong Q4 for Acthar. The analyst wants to see a few more quarters of outperformance, however, before adjusting his estimates. He lowered his price target for Mallinckrodt to $82 citing the group rerating and keeps an Outperform rating on the name.
November 23, 2015
09:18 EDTMNKOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Tyson Foods (TSN), up 2.4%... Mallinckrodt (MNK), up 7.4%. ALSO HIGHER: Novocure (NVCR), up 16.8% after announcing new Phase 3 data from Optune study... CTI BioPharma (CTIC), up 12.7% after the initiation of its rolling new drug application to the FDA for pacritinib... Peabody Energy (BTU), up 14.8% after announcing an asset sale... Sarepta Therapeutics (SRPT), up 5.2% following a positive mention in Barron's. DOWN AFTER EARNINGS: Trina Solar (TSL), down 5.6%. ALSO LOWER: Par Pacific (PARR), down 13.2% after pricing its 3.4M registered direct offering at $22.00... Lions Gate (LGF), down 2.9% after the "Hunger Games" finale opens below the series average.
06:12 EDTMNKValeant questions spread to similar drug companies, WSJ says
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06:03 EDTMNKMallinckrodt reports Q4 adjusted EPS $1.84, consensus $1.77
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November 20, 2015
07:22 EDTMNKMallinckrodt price target lowered to $85 from $130 at Jefferies
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November 19, 2015
09:04 EDTMNKMallinckrodt authoizes $500M expansion to share repurchase program
Mallinckrodt has authorized an incremental $500M share repurchase program. The new authorization permits the company to repurchase up to $500M of Mallinckrodt plc ordinary shares. This new authorization supplements the roughly $200M remaining from the previously authorized share repurchase plan announced in January. Mallinckrodt also authorized management to reduce the company's outstanding debt at its discretion. Both the share repurchase and debt reduction programs are open-ended in time, and based on Mallinckrodt's expected capacity to generate durable earnings and approximately $1B in annual cash flow.
09:02 EDTMNKMallinckrodt board adds $500M to existing share repurchase program
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08:58 EDTMNKMallinckrodt trading halted, pending news
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November 18, 2015
12:06 EDTMNKDrug at center of new pricing concern immaterial to Mallinckrodt, says Northland
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05:51 EDTMNKMallinckrodt price increase raises new questions, WSJ says
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05:39 EDTMNKMallinckrodt raised infant seizure drug price by 2,000%, CBC reported
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November 16, 2015
07:36 EDTMNKMallinckrodt receives FDA clearance for INOmax DSIR plus MRI device
Mallinckrodt announced that the U.S. FDA has cleared INOmax DSIR Plus MRI device for delivery of INOMAX for inhalation during MRI procedures. The INOmax DSIR Plus MRI delivery system is indicated for delivery of INOMAX for inhalation therapy gas into the patient-breathing circuit to provide a constant concentration of nitric oxide to the patient. The INOmax DSIR Plus MRI is indicated for use only with Magnetic Resonance Conditional ventilators validated to be compatible, as identified in the device labeling. The FDA clearance is based on the determination of Substantial Equivalence to the INOmax DSIR. The modifications to INOmax DSIR for the INOmax DSIR Plus MRI device included hardware modifications to the cart, an update of the software to include an MRI set-up wizard and modified labeling. The INOmax DSIR Plus MRI has the same intended therapeutic effect and patient population as the previously cleared INOmax DSIR predicate device.

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