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News Breaks
February 14, 2013
09:11 EDTTEVA, SHPGTeva's generic version of Shire's Adderall XR approved by FDA
Teva (TEVA) announced that the FDA has approved its Abbreviated New Drug Application for the generic version of Shire (SHPG)ís Adderall XR Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30 mg capsules for the treatment of attention deficit hyperactivity disorder. Adderall XR had annual sales, including brand and generic sales, of approximately $2B in the United States.
News For TEVA;SHPG From The Last 14 Days
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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.
07:21 EDTTEVATeva recalls batch of generic Parkinson's drug in U.S., Globes reports
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August 27, 2014
17:49 EDTSHPGGSK, 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
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 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.
07:57 EDTSHPGCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.

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