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Stock Market & Financial Investment News

News Breaks
April 8, 2014
08:46 EDTTEVA, GSKTeva announces first approval, launch of generic Lovaza capsules in the U.S.
Teva (TEVA) announces the approval of the generic equivalent to Lovaza in the United States. Teva believes it is first-to-file and thus far is the only company to receive an approval from FDA. Teva plans to commence shipping immediately. Lovaza Capsules, marketed by GlaxoSmithKline (GSK), had annual sales of approximately $1.1B in the United States, according to IMS data as of December 2013.
News For TEVA;GSK From The Last 14 Days
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August 31, 2014
14:04 EDTGSKWorldwide Business Research to hold a conference
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August 28, 2014
11:22 EDTTEVAMylan 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.
07:34 EDTGSKGSK could start testing Ebola vaccine on humans next week, Bloomberg reports
GlaxoSmithKline could begin tests of its experimental vaccine for Ebola on humans as early as next week in the U.S., Bloomberg reports. GSK is developing the vaccine with the Vaccine Research Center of the National Institutes of Health, and they have received FDA approval to begin the Phase 1 trial, Michael Kurilla, director of the Office of Biodefense, Research Resources and Translational Research, says. Reference Link
07:21 EDTTEVATeva recalls batch of generic Parkinson's drug in U.S., Globes reports
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August 27, 2014
17:49 EDTGSKGSK, Shire rumored to be interested in Tekmira, Daily Mail says
GlaxoSmithKline (GSK) and Shire (SHPG) are rumored to be interested in a bid for Tekmira (TKMR), reports Daily Mail. Tekmira could be a value to potential suitors, capitalized at approximately GBP 400M and the company could cost over GBP 1B in a takeover, Daily Mail adds. Reference Link
08:03 EDTGSKGlaxoSmithKline receives FDA approval for sNDA for Promacta/Revolade
Ligand Pharmaceuticals Incorporated (LGND) announced that its partner GlaxoSmithKline (GSK) has received approval of a supplemental New Drug Application for the once-daily use of Promacta/Revolade in patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. SAA is a blood disorder where the bone marrow fails to make enough red blood cells, white blood cells and platelets.2 Eltrombopag, an oral thrombopoietin receptor agonist, works by helping to induce proliferation and differentiation of bone marrow stem cells to increase production of blood cells.
August 26, 2014
14:42 EDTGSKGlaxoSmithKline receives FDA approval of additional Promacta indication
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08:47 EDTGSKGenetic Technologies says NC court denies GlaxoSmithKline motion to dismiss
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August 25, 2014
12:19 EDTGSKOn The Fly: Midday Wrap
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10:40 EDTGSKBiotechs rise after InterMune acquired by Roche
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August 22, 2014
14:19 EDTGSKViiV Healthcare receives FDA approval for HIV-1 treatment Triumeq
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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
15:35 EDTGSKGlaxoSmithKline receives FDA approval for Arnuity Ellipta in the U.S.
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11:44 EDTGSKMylan 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
08:30 EDTGSKPernix closes acquisition of Treximet
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08:29 EDTGSKPernix Therapeutics to host conference call
Conference call to discuss acquisition of Treximet will be held on August 20 at 9 am. Webcast Link
08:04 EDTGSKPOZEN announces U.S. rights for Treximet acquired by Pernix Therapeutics
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August 19, 2014
05:11 EDTTEVAGamida Cell announces investment, option agreement with Novartis
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August 18, 2014
10:06 EDTTEVALannett 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.

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