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News Breaks
June 20, 2014
09:02 EDTTEVATeva reaches settlement in ProAir HFA patent case
Teva Pharmaceutical announced that it has reached a settlement with Perrigo Pharmaceutical and Catalent Pharma Solutions with respect to four patents for Teva’s ProAir HFA Inhalation Aerosol product. This settlement provides a license to Perrigo and Catalent to sell limited units of Perrigo’s generic version of the product for an initial period beginning December 19, 2016 and lasting until June 2018, when the limits will no longer apply. This settlement dismisses pending litigation in the U.S. District Court for the District of Delaware in which Teva filed suit against Perrigo and Catalent in response to a notice of the filing of an ANDA containing a paragraph certification directed against four of the five patents listed in the Orange Book for ProAir HFA. Additional terms of the settlement are agreed by the parties to remain undisclosed. There are currently no additional challenges to the IP for ProAir HFA and no further litigation pending. Teva will continue to vigorously defend its intellectual property rights relating to its products.
News For TEVA From The Last 14 Days
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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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