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News Breaks
June 17, 2014
08:05 EDTMYL, ACT, TEVA, NVSTeva 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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August 28, 2015
05:32 EDTNVSNovartis renews pledge with WHO to end leprosy
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August 27, 2015
06:01 EDTTEVAStocks with implied volatility below IV index mean; BBY TEVA
Stocks with implied volatility below IV index mean; Best Buy (BBY) 34, Teva (TEVA) 33 according to iVolatility.
August 26, 2015
10:07 EDTMYLMylan initiated with a Buy at Standpoint Research
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06:55 EDTMYLMylan shares may sell off on affirmative Perrigo deal vote, says BMO Capital
With Mylan (MYL) set to hold a shareholder vote on August 28 regarding its proposed acquisition of Perrigo (PRGO), BMO Capital analyst David Maris predicts that if the vote goes in Mylan's favor, he expects Perrigo shares to rise and Mylan shares to fall. Afterward, he feels added overhangs, such as Teva's (TEVA) and Abbott's (ABT) shareholdings and potential short-term selling by arbitrageurs, will come into play, further pressuring Mylan shares.
05:58 EDTMYLPerrigo CEO says company is 'very active in M&A,' Bloomberg reports
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05:56 EDTTEVAStocks with implied volatility below IV index mean; BBY TEVA
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August 25, 2015
17:11 EDTTEVAU.S. District Court rules in Eli Lilly's favor on Alimta vitamin regimen patent
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15:02 EDTNVS, TEVA, MYLMylan says USPTO institutes IPR of two Copaxone patents
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14:40 EDTMYL, TEVATeva Copaxone patents to be reconsidered by regulators, Bloomberg says
14:16 EDTMYLMylan launches generic version of Pfizer's Zosyn Injection
Mylan (MYL) announced the U.S. launch of Piperacillin and Tazobactam for Injection USP, 3.375g Single-dose Vials, which is the generic version of Pfizer's (PFE) Zosyn Injection. This product is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of certain bacteria. Piperacillin and Tazobactam for Injection USP, 3.375g Single-dose Vials had U.S. sales of approximately $72.1M for the 12 months ending June 30, 2015, according to IMS Health. Mylan's launch of this product adds to the company's growing portfolio of more than 145 injectable products available to patients in the U.S. across a broad array of therapeutic categories including oncology, anti-infectives, anesthesia/pain management and cardiovascular.
13:22 EDTMYLMylan comments on 'misleading' Perrigo statements
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11:27 EDTMYL, TEVATeva to refrain from voting at Mylan special meeting
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08:17 EDTTEVATeva multiple low, says Leerink
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August 24, 2015
13:15 EDTNVSFDA expands use of Novartis' Promacta to include children ages 1 and older
Ligand Pharmaceuticals (LGND) announced that the FDA has approved an expanded use for Promacta, a Novartis (NVS) product, to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was acquired by Novartis in March from GlaxoSmithKline (GSK). Promacta was discovered as a result of research collaboration between GSK and Ligand Pharmaceuticals and was developed by GSK. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 years of age and older and in 2008 for use in adult patients with the same condition. The label expansion of Promacta was based on data from two double-blind, placebo-controlled trials, including the largest Phase 3 clinical trial in this patient population. Treatment with Promacta significantly increased and sustained platelet counts among pediatric patients with chronic ITP with an insufficient response to prior chronic ITP therapies, and some patients taking concomitant ITP medications were able to reduce or discontinue their use of these medications, primarily corticosteroids. Promacta should be used only in those whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
12:11 EDTNVSNovartis announces FDA approves expanded use for Promacta
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10:20 EDTTEVATeva says EMA confirms validation of reslizumab MAA
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August 21, 2015
15:22 EDTMYLMylan clarifies certain inaccuracies related to lowered condition to acquire Perrigo
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08:19 EDTMYLMylan to host special shareholder meeting
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05:51 EDTTEVAStocks with implied volatility below IV index mean; GMCR TEVA
Stocks with implied volatility below IV index mean; Teva (TEVA) 25, Keurig Green Mountain (GMCR) 39 according to iVolatility.
05:25 EDTNVSNovartis acquires all remaining rights to Ofatumumab from GSK
Novartis (NVS) announced that it has entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline (GSK). Ofatumumab, a fully human monoclonal antibody which targets CD20, is being developed for relapsing remitting multiple sclerosis, or RRMS, and other autoimmune indications. Novartis previously acquired the rights to Ofatumumab for oncology indications and it is marketed under the brand name Arzerra. Novartis will be responsible for the worldwide development, regulatory and commercialization activities for Ofatumumab. Under the terms of the agreement, Novartis will make an initial upfront payment of $300M to GSK for the acquisition of the compound and a further payment of $200M payable following the start of a phase III study in MS by Novartis. Upon completion of pre-determined milestones, contingent payments of up to $534M may be made. Novartis will also pay royalties of up to 12% to GSK on any future net sales of Ofatumumab in autoimmune conditions.
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