Key Developments: Teva Pharmaceutical Industries Ltd (TEVA.N)

TEVA.N on New York Stock Exchange

11 Jul 2014
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Latest Key Developments (Source: Significant Developments)

Teva Pharmaceutical Industries Ltd receives CHMP positive opinion for seasonique Extended-Regimen Contraceptive for Marketing Authorization in Several European Countries
Friday, 4 Jul 2014 02:00am EDT 

Teva Pharmaceutical Industries Ltd:Says European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinion in referral procedure regarding authorization of extended-regimen oral contraceptive.Seasonique (levonorgestrel (0.15 mg)/ethinyl estradiol (0.03 mg) and low-dose ethinyl estradiol (0.01 mg) tablets) for the prevention of pregnancy.CHMP concluded that the benefits of Seasonique outweigh its risks clearing the way for Seasonique`s approval by local health authorities of the European Union (EU) Member States and launch in select countries throughout Europe by the end of 2014.Seasonique is an extended regimen birth control option that contains 84 active pills made up of levonorgestrel/ethinyl estradiol and is followed by seven days of ethinyl estradiol tablets.Ethinyl estradiol tablets are used during the seven days, instead of a placebo interval, allowing women to have four scheduled periods a year and potentially lessening the withdrawal symptoms that result from a sudden, sharp decrease in hormones.Seasonique is backed by extensive clinical trials and real-world experience, and is more than 99 percent effective when taken as directed.  Full Article

Teva Pharmaceutical Industries Ltd files citizen petition with U.S. Food and Drug Administration
Thursday, 3 Jul 2014 08:00am EDT 

Teva Pharmaceutical Industries Ltd:Files Citizen Petition (CP) 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 (NDA) and FDA responded by asking Teva to resubmit the information as a CP.  Full Article

Teva Pharmaceutical Industries Ltd announces FDA approves expanded label for AZILECT for treatment across all stages of Parkinson's disease
Monday, 9 Jun 2014 08:00am EDT 

Teva Pharmaceutical Industries Ltd:U.S. Food and Drug Administration (FDA) has expanded indication for AZILECT (rasagiline tablets) from monotherapy and adjunct to levodopa (LD) to include adjunct to dopamine agonists (DAs).New indication reflects that AZILECT can be used alone or in combination with other Parkinson's disease (PD) medications.Approval reinforces growing clinical evidence demonstrating benefit of AZILECT across all stages of PD.FDA approval of expanded label is based on a supplemental new drug application (sNDA) submitted by Teva, supported by data from the ANDANTE study ( A dd o N to D opamine A go N ists in the T r E atment of Parkinson's disease).Study demonstrated AZILECT providesclinical benefit by significantly improving total Unified Parkinson's Disease Rating Scale (UPDRS) scores compared to placebo in patients on DA monotherapy, while demonstrating tolerability.  Full Article

Teva Pharmaceutical Industries Ltd announces favorable European patent office ruling in COPAXONE patent proceeding
Tuesday, 27 May 2014 02:50pm EDT 

Teva Pharmaceutical Industries Ltd:Says European Patent Office issued decision in favor of Teva in patent opposition proceeding filed by Synthon BV, Mylan and an unidentified third party.On Sept 6, 2012, three opponents commenced an opposition proceeding against European Patent EP 2 177 528, patent for COPAXONE (glatiramer acetate injection) expiring Sept. 09, 2025.European Patent Office specifically determined that claims 1-12 of the '528 patent are valid.Therefore infringing follow-on glatiramer products would not be able to launch prior to patent expiry.Teva will continue to vigorously defend its COPAXONE intellectual property rights against infringement wherever they are challenged.  Full Article

Teva Pharmaceutical Industries receives FDA approval for QVAR (beclomethasone dipropionate HFA) with dose counter
Friday, 23 May 2014 08:00am EDT 

Teva Pharmaceutical Industries Ltd:Says the U.S. Food and Drug Administration (FDA) has approved the use of QVAR((reg))(beclomethasone dipropionate HFA) with a dose counter for ongoing treatment of asthma as a preventative therapy in patients five years of age and older.Dose counter is designed to help asthma patients, as well as their caregivers, keep track of the number of doses remaining in the canister.  Full Article

Teva Pharmaceutical Industries Ltd and Active Biotech to continue with development of Nerventra for Multiple Sclerosis following confirmation of CHMP Opinion
Friday, 23 May 2014 02:30am EDT 

Teva Pharmaceutical Industries Ltd and Active Biotech:Committee for Medicinal Products for Human Use (CHMP) confirmed Jan. 23, opinion to recommend against approval for treatment of relapsing-remitting multiple sclerosis (RRMS) in European Union (EU) at this time.Both companies remain committed to NERVENTRA (laquinimod) clinical development program for multiple sclerosis (MS) and are focused on evaluating the CHMP feedback to determine potential next steps.To further confirm benefits of NERVENTRA on disability progression, Teva is conducting the CONCERTO trial, MS trial with disability progression as the primary endpoint.Says ongoing CONCERTO trial is third Phase III study in RRMS and explores daily doses of NERVENTRA 0.6 mg and 1.2 mg.In addition, Teva is investigating potential of NERVENTRA in progressive forms of MS.Says first trial for this indication is planned to be initiated soon.  Full Article

Teva Pharmaceutical Industries announces FDA acceptance of sNDA Filing for pediatric indication for QNASL
Tuesday, 13 May 2014 08:30am EDT 

Teva Pharmaceutical Industries Ltd:Says U.S. Food and Drug Administration (FDA) accepts for review the supplemental new drug application (sNDA) for a lower dose QNASL Nasal Aerosol for the treatment of seasonal and perennial allergic rhinitis in children 4-11 years of age.QNASL is a waterless nasal allergy aerosol available only by prescription.  Full Article

Teva Pharmaceutical Industries Ltd announces FDA approves Teva's SYNRIBO (Omacetaxine Mepesuccinate) for injection for home administration
Monday, 5 May 2014 08:00am EDT 

Teva Pharmaceutical Industries Ltd:FDA approvs SYNRIBO (omacetaxine mepesuccinate) for injection, for subcutaneous use, to include home administration, and also approved a related Medication Guide and Instructions for Use.With this approval, physicians who treat adults with chronic or accelerated phase CML who are no longer responding to, or who could not tolerate, two or more tyrosine kinase inhibitors (TKIs) will have option to allow their patients to administer SYNRIBO((reg))therapy at home.Teva is working to finalize a comprehensive specialty pharmacy support program which will help facilitate successful home administration of SYNRIBO for HCPs, their patients and caregivers.This program is expected to go live as early as possible in the second quarter of 2014.  Full Article

Teva Pharmaceutical Industries Ltd reaffirms FY 2014 outlook
Thursday, 1 May 2014 07:01am EDT 

Teva Pharmaceutical Industries Ltd:Reaffirms its FY 2014 revenues and EPS guidance.FY 2014 revenue of $20.469 bln, EPS of $4.88 - Thomson Reuters I/B/E/S.  Full Article

Teva Pharmaceutical Industries declares dividend
Thursday, 1 May 2014 07:00am EDT 

Teva Pharmaceutical Industries Ltd:Declares a cash dividend for the first quarter of 2014 of NIS 1.21 per share (about $0.347 according to the rate of exchange on April 29).Record date will be May 20, and payment date will be June 2.  Full Article

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