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News Breaks
June 17, 2014
08:05 EDTNVS, MYL, ACT, TEVATeva 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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April 16, 2015
15:40 EDTNVS, MYL, TEVAGeneric Copaxone approval a bit early but expected, says BMO Capital
BMO Capital believes FDA approval for Sandoz (NVS) and Momenta's (MNTA) generic 20mg Copaxone came slightly earlier than the market expected, but the firm added that the generic threat has been well expected. The firm added that it appears Mylan’s (MYL) generic Copaxone hasn't been approved yet, leaving a "legitimate question" about why the FDA approved one generic and not the other. BMO thinks Teva's rate of conversion to the 40mg dose will help retain patients on the Copaxone franchise and it keeps an Outperform rating on Teva shares.
13:42 EDTTEVATeva shares defended at Evercore ISI
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12:37 EDTTEVA, NVSMomenta confirms Glatopa approval, to receive $10M payment
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12:35 EDTNVS, TEVASandoz receives FDA approval for Glatopa as generic competitor to Copaxone
Sandoz, a Novartis (NVS) company, announced the U.S. approval of Glatopa, the first generic version of Teva's (TEVA) Copaxone 20 mg/ml one-time-daily multiple sclerosis therapy. Glatopa, developed in collaboration with Momenta (MNTA) and produced entirely in the U.S., is indicated for the treatment of patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging features consistent with MS.
12:35 EDTTEVAFDA denies Teva attempt to block generic Copaxone
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06:16 EDTTEVAFormer Teva CEO appointed to position of CEO at Ovid Therapeutics
Ovid Therapeutics, a privately held biopharmaceutical company focused on developing therapies for rare and orphan diseases of the brain, appointed Dr. Jeremy Levin as CEO. Levin has served as Chairman of Ovid since 2014 and will continue to serve in this role. Most recently, Levin served as CEO of Teva.
05:27 EDTNVSAlcon receives FDA approval of AcrySof IQ ReSTOR +2.5 Diopter IOL
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April 15, 2015
19:34 EDTTEVAVIVUS files patent infringement lawsuit against Teva
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09:02 EDTMYLRBC sees Akorn as possible play on Perrigo takeover interest
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April 14, 2015
08:03 EDTTEVATeva, Eagle announce NDA for bendamustine HCI accepted for filing
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06:18 EDTACTActavis urges U.S. appeals court to reverse decision on Namenda, AP reports
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April 13, 2015
16:51 EDTNVSDiplomat Pharmacy to dispense Novartis' JADENU
Diplomat Pharmacy is set to distribute JADENU, a drug recently approved by the U.S. FDA to treat patients with chronic iron overload. JADENU is a new oral formulation of EXJADE for the treatment of chronic iron overload due to blood transfusions in patients age 2 and older, and chronic iron due to NTDT in patients age 10 and older.
16:37 EDTACTActavis announces availability of 52mg Liletta to prevent pregnancy
Actavis and Medicines360, a nonprofit women's health pharmaceutical company, announced that Liletta 52 mg is now available in the U.S. for use by women to prevent pregnancy for up to three years.
15:12 EDTMYLMylan enters settlement, license agreement with Pfizer regarding Viagra
Mylan (MYL) announced that its subsidiaries Mylan Inc. and Mylan Pharmaceuticals have entered into a settlement and license agreement with Pfizer (PFE), Pfizer Limited and Pfizer Ireland Pharmaceuticals to settle patent litigation relating to Mylan's Abbreviated New Drug Application filed with the U.S. FDA for Sildenafil Citrate Tablets 25 mg, 50 mg, and 100 mg. This product is the generic version of Viagra, which is indicated to treat erectile dysfunction. Under the terms of the agreement, Mylan will be able to launch its ANDA products pursuant to a royalty-bearing license as early as December 11, 2017, or sooner under certain conditions, subject to FDA approval. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. For the 12 months ending Dec. 31, 2014, Viagra had U.S. sales of approximately $1.3B, according to IMS Health.
10:52 EDTACTMeister says Actavis bought great companies, can continue growing
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09:27 EDTACTActavis and Medicine360 announce Liletta es available in the U.S.
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08:34 EDTACTZoetis names Actavis Executive Chairman Paul Bisaro to board
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07:56 EDTTEVA, MYLMylan, Teva, Perrigo price targets raised at JPMorgan
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06:49 EDTMYLMylan notifies Perrigo of HSR filing regarding proposed acquisition
Mylan N.V. (MYL) announced that it has provided Perrigo (PRGO) with notice of its filing of the premerger notification under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 with the U.S. Federal Trade Commission and the U.S. Department of Justice Antitrust Division regarding its proposed acquisition of Perrigo, as required by the HSR Act. Mylan proposed to acquire Perrigo for $205 per share in a cash-and-stock transaction on April 6.
05:21 EDTNVSNovartis to present new data that confirms high efficacy of Gilenya
Novartis announced new Gilenya analyses to be presented at the 67th American Academy of Neurology, or AAN, Annual Meeting in Washington, DC, from April 18-25, showing how Novartis is advancing methods assessing the impact of relapsing multiple sclerosis, or RMS, for patients and physicians. Data will show how adding brain shrinkage to an existing tool to assess MS disease activity will give a more precise prediction of the likelihood of future disability progression. Accurate assessment of disease activity is key to guide treatment decisions in RMS. A pooled analysis from the two-year phase III FREEDOMS and FREEDOMS II trials will further confirm Gilenya's high efficacy in previously-treated patients with highly-active RMS in achieving 'no evidence of disease activity' across four key measures: relapses, MRI lesions, brain shrinkage and disability progression. Achieving NEDA4 is especially critical for highly-active RMS patients, who are likely to lose more physical and cognitive functions over time despite being treated.
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