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News Breaks
January 24, 2014
08:13 EDTACTI, TEVATeva, Active Biotech's NERVENTRA 'not favorable' by CHMP
Teva (TEVA) and Active Biotech (ACTI) announced that both companies remain committed to the NERVENTRA clinical development program for multiple sclerosis following the announcement of a negative opinion for the treatment of relapsing-remitting multiple sclerosis by the Committee for Medicinal Products for Human Use of the European Medicines Agency. The CHMP has concluded that the risk-benefit profile of NERVENTRA is not favorable at this time. In accordance with European regulations, Teva and Active Biotech intend to request a re-examination of the CHMP opinion. Teva and Active Biotech are focusing on evaluating the CHMPís review and will continue to liaise closely with the EMA in working to make NERVENTRA available as a new treatment option for patients with RRMS in Europe.
News For ACTI;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 Tevaís 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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