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News Breaks
June 20, 2014
09:24 EDTPRGO, TEVAPerrigo announces settlement in Proair HFA patent case
Perrigo (PRGO) and its partner, Catalent, announced that they have settled their first to file Hatch Waxman litigation with Teva (TEVA) with respect to a generic version of Proair HFA. Pursuant to the settlement, Perrigo has a limited quantity license to launch a generic version of Proair HFA starting on December 19, 2016 and an unlimited quantity license beginning after June 30, 2018. Proair® HFA indicated in patients 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. Brand sales were approximately $1.4B over the last 52-weeks according to Symphony Health Solutions.
News For PRGO;TEVA From The Last 14 Days
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August 29, 2014
09:26 EDTPRGOPerrigo could benefit from potential Omega deal, says RBC Capital
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08:18 EDTPRGOPerrigo among companies showing interest in Omega Pharma, Bloomberg says
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August 28, 2014
12:41 EDTPRGOPerrigo among companies showing interest in Omega Pharma, Bloomberg says
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 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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