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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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July 29, 2015
06:14 EDTMNKBellerophon expands license agreement with Mallinckrodt for INOpule development
Bellerophon (BLPH) has expanded its license agreement with INO Therapeutics, a division of Mallinckrodt (MNK), allowing Bellerophon to develop INOpulse for the treatment of three additional cardiopulmonary diseases, including chronic thromboembolic pulmonary hypertension, pulmonary hypertension associated with sarcoidosis and pulmonary hypertension associated with pulmonary edema from high altitude sickness. Bellerophon's existing license with INO Therapeutics covers the development of INOpulse for pulmonary arterial hypertension, pulmonary hypertension associated with COPD and pulmonary hypertension associated with idiopathic pulmonary fibrosis. Terms of the expanded license agreement include a 5% royalty on net sales for the three additional indications.
July 27, 2015
17:58 EDTMNKMallinckrodt to sell CMDS business to Guerbet for $270M
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July 24, 2015
10:00 EDTIGOn The Fly: Analyst Upgrade Summary
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08:31 EDTIGIGI Laboratories upgraded to Buy with $11 target at Roth Capital
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06:14 EDTIGIGI Laboratories upgraded to Buy from Neutral at Roth Capital
July 23, 2015
19:06 EDTIGOn The Fly: After Hours Movers
UP AFTER EARNINGS: Amazon (AMZN), up 17.2%... Marketo (MKTO), up 15.4%... Juniper Networks (JNPR), up 9.9%... NetGear (NTGR), up 9.2%... Qlik Technologies (QLIK), up 9.1%... LogMeIn (LOGM), up 9.9%... Pandora (P), up 10.3%... Mitek Systems (MITK), up 7.8%... Proofpoint (PFPT), up 5.1%... Supreme Industries (STS), up 4.7%... Skyworks (SWKS), up 3.6%... IGI Laboratories (IG), up 3.7%... Maxim Integrated Products (MXIM), up 4.1%... Boyd Gaming (BYD), up 4.1%... Trinity Industries (TRN), up 5%... Trinity Industries (N), up 3.2%... Starbucks (SBUX), up 4.5%. ALSO HIGHER: Qorvo (QRVO), up 2.7% after Skyworks reported quarterly results. DOWN AFTER EARNINGS: TrueCar (TRUE), down 33.1% after reporting quarterly results and cutting fiscal 2015 revenue guidance... Tripadvisor (TRIP), down 9.2%... Align Technology (ALGN), down 7.4%... Capital One (COF), down 4.9%... PMC-Sierra (PMCS), down 9.1%... athenahealth (ATHN), down 2.1%. ALSO LOWER: Sunesis Pharmaceuticals (SNSS), down 59.7% after giving vosaroxin regulatory update... Avalanche Biotechnologies (AAVL), down 5.6% after CEO Thomas Chalberg, Jr., Ph.D. resigns and Hans Hull name interim CEO.
16:38 EDTIGIGI Laboratories sees FY15 revenue $35M-$40M, consensus $38.49M
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16:37 EDTIGIGI Laboratories reports Q2 adjusted EPS (4c), consensus (8c)
Reports Q2 revenue $8.9M, consensus $7.63M.
16:10 EDTIGIGI Laboratories submits sixth ANDA of 2015
IGI Laboratories has submitted its sixth abbreviated new drug application to the FDA of 2015, which brings the company's total number of ANDA submissions now pending at the FDA to twenty-eight.
July 17, 2015
08:38 EDTMNKLeerink puts 25% odds on Teva, Mylan deal within 12 months
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