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News Breaks
March 3, 2014
08:16 EDTTEVA, ALXATeva launches ADASUVE in U.S.
Teva Pharmaceutical (TEVA) announced the commercial launch of ADASUVE inhalation powder 10 mg, the first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. ADASUVE is administered through Alexza Pharmaceuticals' (ALXA) innovative proprietary Staccato single-use, hand held drug delivery technology system. This new drug-device combination product provides rapid systemic delivery by inhalation of a thermally-generated aerosol of loxapine, a first generation antipsychotic, to the lung. Administration of ADASUVE results in rapid absorption of loxapine, with a maximum plasma concentration achieved in approximately 2 minutes. Efficacy was demonstrated in two clinical trials in acute agitation: one in schizophrenia and one in bipolar I disorder. Patients receiving ADASUVE experienced a statistically significant reduction in agitation at two hours, with an effect seen as early as ten minutes post-dose.
News For TEVA;ALXA 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 EDTALXA, TEVAAlexza 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

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