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News Breaks
June 9, 2014
08:15 EDTTEVAFDA approves expanded label for Teva's Azilect
Teva Pharmaceutical Industries announced the U.S. Food and Drug Administration has expanded the indication for AZILECT from monotherapy and adjunct to levodopa to now include adjunct to dopamine agonists. The new indication reflects that AZILECT can be used alone or in combination with other Parkinson's disease medications. The approval reinforces the growing clinical evidence demonstrating the benefit of AZILECT across all stages of PD. The FDA approval of the expanded label is based on a supplemental new drug application submitted by Teva, supported by data from the ANDANTE study. The study demonstrated AZILECT provides a clinical benefit by significantly improving total Unified Parkinson's Disease Rating Scale scores compared to placebo in patients on DA monotherapy, while demonstrating tolerability.
News For TEVA From The Last 14 Days
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October 20, 2014
06:28 EDTTEVAAllergan price target raised to $210 from $190 at Citigroup
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October 14, 2014
11:23 EDTTEVABIND Therapeutics and The Conference Forum hold a conference
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11:19 EDTTEVATeva upgraded to Buy from Hold at Standpoint Research
October 9, 2014
16:11 EDTTEVAAlexza reports 32,278 Adasuve units shipped to Teva in Q3
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October 8, 2014
08:05 EDTTEVATeva initiates NDA submission to FDA for CEP-33237
Teva Pharmaceutical announced the initiation of a rolling New Drug Application submission to the U.S. Food and Drug Administration for hydrocodone bitartrate extended-release tablets designed with Teva’s proprietary technology providing potential abuse-deterrent properties CEP-33237 as allowed for fast track designated products. Teva expects to complete the NDA submission by the end of 2014. Teva also announced positive results from a nasal Human Abuse Liability study which supports the NDA. The nasal HAL study found that in nondependent, recreational opioid users, abuse potential for crushed intranasal CEP-33237 was significantly lower than intranasal immediate-release hydrocodone. Teva has now completed positive HAL studies in the two most common routes of hydrocodone abuse, oral and intranasal. CEP-33237 demonstrated a safety profile in the Phase III study that is consistent with the known safety profile of hydrocodone and other opioid analgesic therapies. Adverse events reported in 5% or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included nausea, constipation, vomiting, headache, somnolence and dizziness.
06:47 EDTTEVALawmakers may push for new regulations on generic drug makers, NY Times says
After the prices of some generic drugs soared more than 1,000% over the last year, two influential members of Congress are probing the sector and threatening to look to impose new regulations on it, according to The New York Times. Generic drug makers include Teva (TEVA), Mylan (MYL), Actavis (ACT), and Lannett (LCI).Reference Link
October 6, 2014
11:58 EDTTEVATeva simplifaction plans expected but positive, says BMO Capital
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08:32 EDTTEVATeva identifies 14 pipeline projects for discontinuation or divestment
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08:32 EDTTEVATeva announces results of strategic review of core specialty therapeutic areas
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