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News Breaks
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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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

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