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News Breaks
March 24, 2014
13:30 EDTMYL, TEVADistrict Court upholds Mylan's patents on performist inhalation solution
Mylan announced the United States District Court for the Northern District of West Virginia issued a decision upholding the validity of all patents asserted by Mylan, protecting Perforomist Inhalation Solution. Mylan previously sued Teva alleging that Teva's Abbreviated New Drug Application for this product infringed four Mylan patents covering Perforomist. After a full trial, the Court entered a judgment finding infringement of the patents-in-suit, rejecting Teva's defenses, and enjoining Teva from making, using, offering to sell, selling or importing the inhalation product described in Teva's ANDA. The Court's decision also prevents Teva's ANDA, which has yet to receive a tentative approval from the FDA, from receiving final approval prior to expiration of U.S. Patent Nos. 6,667,344; 6,814,953; 7,348,362; and 7,462,645, which cover Perforomist through June 2021.
News For MYL;TEVA From The Last 14 Days
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August 28, 2014
11:22 EDTTEVA, MYLMylan ANDA for three times per week generic Copaxone accepted by FDA for filing
Mylan (MYL) announced that its abbreviated new drug application for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration. This product is the generic version of Teva's (TEVA) Copaxone 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Copaxone 40 mg/mL had U.S. sales of approximately $411.5M for the 12 months ending June 30, 2014, according to IMS Health.
07:21 EDTTEVATeva recalls batch of generic Parkinson's drug in U.S., Globes reports
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August 22, 2014
08:02 EDTMYLMylan launches first generic Klor-Con Extended-release tablets
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August 21, 2014
15:16 EDTTEVADEA restricts painkiller drug prescriptions to curb abuse, WSJ reports
The Drug Enforcement Agency, or DEA, will reclassify hydrocodone combination painkiller drugs and place them in the category of medical substances that have the highest potential for harm in an attempt to curb the widespread abuse of the drugs, according to The Wall Street Journal. The rescheduling of the drugs will take effect in 45 days and result in people being able to obtain the drug for only 90 days without obtaining a new prescription. Major manufacturers of these drugs include Teva Pharmaceutical (TEVA), Mallinckrodt (MNK), AbbVie (ABBV), and Actavis (ACT). Reference Link
August 20, 2014
11:44 EDTMYLMylan completes second bidding round for GSK prescription portfolio, WSJ says
Mylan (MYL), TPG Capital, Advent International, KKR (KKR), Warburg Pincus and a few Indian prescription manufacturers have completed the second round of bidding for GlaxoSmith Kline's (GSK) portfolio of mature medications, according to The Wall Street Journal, citing people familiar with the sales process. GSK noted that it aims to sell a portfolio of drug brands in the U.S. and EU with yearly sales of approximately $1.66B. Reference Link
11:33 EDTMYLMylan into second round of bidding for GSK drug portfolio, WSJ reports
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August 19, 2014
11:44 EDTMYLMylan launches generic Precedex Injection
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05:11 EDTTEVAGamida Cell announces investment, option agreement with Novartis
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August 18, 2014
10:06 EDTTEVA, MYLLannett surges after upbeat Q4, FY14 outlook
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08:50 EDTTEVATeva management to meet with JPMorgan
Meeting to be held in Boston on August 20 hosted by JPMorgan.
August 14, 2014
17:08 EDTTEVASoros Fund Management gives quarterly update on stakes
NEW STAKES: CONSOL Energy (CNX), Google (GOOG), Level 3 (LVLT), Time Warner (TWC), and New Oriental (EDU). INCREASED STAKES: YPF SA (YPF), Apple (AAPL), Facebook (FB), AIG (AIG), and American Airlines (AAL). DECREASED STAKES: Teva (TEVA), Liberty Global (LBTYK), Barrick Gold (ABX), EQT (EQT), and Comcast (CMCSA). LIQUIDATED STAKES: FedEx (FDX), Monster Beverage (MNST), Google (GOOGL), Devon Energy (DVN), Marathon Petroleum (MPC).
12:58 EDTTEVAJANA Partners gives quarterly update on stakes
NEW STAKES: Apache (APA), FMC Corp (FMC), Civeo (CVEO), PetSmart (PETM), and Charter Communications (CHTR). INCREASED STAKES: Actavis (ACT), AIG (AIG), Mallinckrodt (MNK), HD Supply (HDS), and American Capital (ACAS). DECREASED STAKES: Liberty (LVNTA), Oil States International (OIS), eBay (EBAY), Liberty Media (LMCA), and Liberty Interactive (LINTA). LIQUIDATED STAKES: Sirius XM (SIRI), Juniper (JNPR), Golar LNG (GLNG), Outerwall (OUTR), and Teva (TEVA).

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