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Stock Market & Financial Investment News

News Breaks
June 25, 2014
05:32 EDTMYL, ACT, NVS, SHPGShire says New Jersey court found Vyvanse patents infringed
Shire announces that Judge Stanley Chesler of the U.S. District Court for the District of New Jersey granted Shire's summary judgment motion in a patent infringement lawsuit, holding that certain claims of the patents protecting Vyvanse were both infringed and valid. The ruling prevents the five pharmaceutical manufacturers who have filed Abbreviated New Drug Applications from launching generic versions of Vyvanse until the earlier of either a successful appeal to the U.S. Court of Appeals for the Federal Circuit, or the expiration of these patents in 2023. To appeal successfully, the ANDA Defendants must overturn the court's rulings for each of the 18 patent claims, Shire said. The court's summary judgment ruling concerning Shire's motion included 18 patent claims from four of the FDA Orange Book-listed patents for Vyvanse, which cover Vyvanse's active ingredient, the lisdexamfetamine dimesylate compound, and a method of using lisdexamfetamine dimesylate for the treatment of ADHD. Shire's lawsuit is against the five ANDA defendants that filed ANDAs with the FDA seeking to market generic versions of Vyvanse. The defendants are Actavis (ACT), Amneal Pharmaceuticals, Mylan (MYL), Roxane Laboratories and Novartis' (NVS) Sandoz.
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April 17, 2015
14:21 EDTMYLTeva weighing potential bid for Mylan, Dow Jones says
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12:56 EDTMYLFederal Circuit upholds Mylan's patents on Perforomist inhalation solution
Mylan (MYL) announced the United States Court of Appeals for the Federal Circuit upheld the validity and infringement of all four patents asserted by Mylan Specialty, L.P. protecting its Perforomist Inhalation Solution. The Court summarily affirmed the previous decision by the district court against Teva (TEVA). Today's decision prevents Teva from receiving final approval of its ANDA from the FDA prior to expiration of U.S. Patent Nos. 6,667,344; 6,814,953; 7,348,362; and 7,462,645. Those patents cover Perforomist until they expire in June 2021.
08:00 EDTMYLTeva patent loss should move management to acquire Mylan, says Cowen
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05:53 EDTMYLStocks with implied volatility movement; XLNX MYL
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April 16, 2015
15:40 EDTMYL, NVSGeneric 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 Mylanís (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.
12:37 EDTNVSMomenta confirms Glatopa approval, to receive $10M payment
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12:35 EDTNVSSandoz 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.
05:27 EDTNVSAlcon receives FDA approval of AcrySof IQ ReSTOR +2.5 Diopter IOL
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April 15, 2015
09:02 EDTMYLRBC sees Akorn as possible play on Perrigo takeover interest
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April 14, 2015
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 EDTMYLMylan, Teva, Perrigo price targets raised at JPMorgan
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07:20 EDTSHPGShire price target raised to $288 from $267 at JPMorgan
JPMorgan raised its price target for Shire to $288 after lifting its estimates for Lifitegrast in dry eye following the FDA's Priority Review designation. The firm believes the FDA is very likely to approve the application in October of this year, without waiting for the third Phase III study late 2015. It upped its 2020 Lifitegrast forecasts by $600M to $900M and reiterates an Overweight rating on Shire.
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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