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News Breaks
June 17, 2014
08:05 EDTTEVA, MYL, NVS, ACTTeva reaches settlement in NUVIGIL patent case
Teva (TEVA) announced that it has reached settlements with Sandoz (NVS), Actavis (ACT), Lupin and Apotex with respect to U.S. Patent 7,132,570 for Teva’s wakefulness product, NUVIGIL tablets. These settlements dismiss a pending appeal with the United States Court of Appeals for the Federal Circuit of a trial court decision that found the ‘570 patent to be valid and infringed. Teva has reached settlements with each of these companies, granting licenses to allow these parties to market their generic products 180 days after Mylan (MYL), the first generic company to file an abbreviated new drug application for the 50 mg, 150 mg, and 250 mg dosages of NUVIGIL. The settlements allow Actavis to launch generic 100 mg and 200 mg dosages in June 2016, and the others may launch these dosages 180 days after Actavis in the 100 mg and 200 mg dosage forms. Additional terms of the settlements are agreed by the parties to remain undisclosed. Previously, Teva settled its patent infringement litigation regarding the ‘570 patent against Mylan, which allowed Mylan to begin selling generic versions of 50 mg, 150 mg, and 250 mg NUVIGIL® under license beginning in June 2016, or earlier under certain circumstances.
News For TEVA;MYL;NVS;ACT From The Last 14 Days
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October 23, 2014
05:21 EDTNVSNovartis AIN457 meets primary endpoint in two Phase III studies in AS
Novartis announced that AIN457 met primary and key secondary endpoints in two pivotal Phase III studies, MEASURE 1 and MEASURE 2, in patients with ankylosing spondylitis, or AS. Key endpoints included improvements in signs and symptoms of the disease versus placebo and associated improvements in physical function and quality of life. Secukinumab is an investigational medicine that works by stopping the action of interleukin- 17A, a protein that is central to the development of inflammatory diseases, including AS. MEASURE 1 and MEASURE 2 enrolled a combined total of approximately 600 patients. Detailed results of the studies will be presented at an upcoming medical congress. Joint regulatory applications for secukinumab in AS and PsA are planned for 2015. This follows the secukinumab global regulatory applications for moderate- to-severe plaque psoriasis which were filed in October 2013 with regulatory decisions anticipated in late 2014 or early 2015.
October 22, 2014
11:59 EDTMYLStocks with call strike movement; MYL AMZN
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09:16 EDTMYLAbbott sees Q4 reported sales growth in high single digits
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08:38 EDTACTActavis signs option to acquire Rhythm Health
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07:44 EDTNVSGlaxoSmithKline backs FY14 view for core EPS 'broadly similar' to FY13
GlaxoSmithKline (GSK) continues to expect full year 2014 core EPS to be broadly similar to 2013 at CER and on ex-divestment basis. Glaxo says its proposed 3-part transaction with Novartis (NVS) is on track for completion in 1H15.
October 21, 2014
07:15 EDTNVSFDA to hold workshop on breast cancer drug development
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06:44 EDTACTActavis among bidders for Omega Pharma, Bloomberg reports
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October 20, 2014
18:51 EDTACTOn The Fly: After Hours Movers
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15:09 EDTNVSNovartis reports FDA advisory committee recommends approval of secukinumab
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the FDA voted unanimously to support the approval of AIN457, or secukinumab, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. A Biologics License Application for secukinumab is currently under FDA review with an anticipated action date in early 2015.
08:04 EDTMYLGerman fund pressured to sell Mylan stake over drug used in executions, FT says
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07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
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07:20 EDTMYLInternational Continence Society to hold annual meeting
ICS Annual Meeting 2014 is being held in Rio de Janeiro, Brazil on October 20-24.
06:28 EDTTEVA, ACTAllergan price target raised to $210 from $190 at Citigroup
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October 17, 2014
14:50 EDTNVSBARDA asks labs to ramp up Zmapp production, Reuters says
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09:47 EDTACTValeant will not raise Allergan bid ahead of record date, CNBC reports
Valeant (VRX) will not raise its hostile takeover bid for Allergan (AGN) ahead of the record date for the vote, CNBC's David Faber reports. Allergan (AGN) is not currently in takeover talks with Actavis (ACT), Faber added.
09:45 EDTACTAllergan not in deal talks with Actavis, CNBC reports
October 16, 2014
17:27 EDTACTNoven files patent infringement suit against Actavis
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15:10 EDTACTAmerican College of Gastroenterology to hold annual meeting
ACG Annual Scientific Meeting 2014 to be held in Philadlephia, PA on October 17-22.
08:08 EDTACTActavis confirms generic Quillivant XR patent challenge
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08:02 EDTACTIronwood announces initiation of Phase II linaclotide trial
Ironwood Pharmaceuticals (IRWD) announced the initiation of a Phase II clinical trial evaluating linaclotide for the treatment of adults suffering from opioid-induced constipation. Data are expected in the second half of 2015. The clinical trial is being conducted jointly by Ironwood and Actavis plc (ACT), Ironwood’s co-development and co-promotion partner for linaclotide in the United States. Linaclotide is a guanylate cyclase-C agonist approved by the FDA for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Linaclotide is not currently approved for the treatment of OIC. The randomized, double-blind, placebo-controlled, multi-site Phase II clinical trial is expected to enroll approximately 240 adult patients with chronic, non-cancer pain who have been receiving a stable dose of an opioid analgesic and suffer from constipation, defined as fewer than three spontaneous bowel movements per week. Patients will be randomized to receive 145 mcg of linaclotide, 290 mcg of linaclotide, or placebo for eight weeks. The primary endpoint of the trial is an increase in SBM frequency. Additionally, a number of secondary endpoints and exploratory analyses intended to inform future development plans are included in the study design.
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