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July 3, 2014
08:11 EDTTEVATeva files petition with FDA regarding COPAXONE
Teva Pharmaceutical announced that the company has filed a citizen petition regarding the approvability of purported generic versions of COPAXONE. Teva submitted this CP according to the FDA’s procedural guidance and in accordance with the agency’s desire to facilitate public review and comment regarding new scientific data on gene expression. Indeed, Teva previously submitted much of this information to its COPAXONE New Drug Application and FDA responded by asking Teva to resubmit the information as a CP. The FDA said, “This will allow others the opportunity to comment and participate in the decision-making process, will allow Teva the opportunity to comment publicly on the views and opinions of others, and will facilitate creation of an administrative record on which the Agency may base future decisions."
News For TEVA From The Last 14 Days
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September 2, 2014
08:02 EDTTEVATeva reports statistically significant results in reslizumab trial
Teva Pharmaceutical Industries announced that reslizumab, an investigational anti-IL-5 monoclonal antibody, demonstrated clear levels of efficacy in achieving the primary endpoint of reduction in the frequency of clinical asthma exacerbations compared to placebo in two pivotal Phase III studies in patients with inadequately controlled moderate to severe asthma with elevated levels of blood eosinophils. In both trials, reslizumab treatment showed both clinically relevant and statistically significant reductions in the frequency of CAE compared to placebo. Reslizumab has also demonstrated a positive effect on lung function and asthma control in the Phase III program . The combination of an effect on clinically important exacerbations and on improvements and preservation of lung function suggest that reslizumab may be a uniquely differentiated treatment for patients with moderate to severe asthma with elevated levels of blood eosinophils. This initial set of results shows the adverse event profile of reslizumab was comparable to placebo in both trials. The incidence of common AEs was consistent with those seen in a moderate to severe asthma population, the most frequent being upper respiratory tract infections, asthma and headache. Further analyses of additional efficacy and safety data are ongoing. These new data are from two global Phase III 12-month, randomized, double-blind, placebo-controlled, parallel-group studies, evaluating the efficacy and safety of intravenously administered reslizumab once every four weeks, compared to placebo in asthma patients that are inadequately controlled by standard of care therapy.
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 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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