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April 15, 2014
08:07 EDTMYL, ACTActavis announces agreement related to Generess FE patent challenge litigation
Actavis (ACT) announced that it has entered into an agreement with Mylan (MYL) and Famy Care to settle all outstanding patent litigation related to Mylan's generic version of Generess. Under the terms of the agreement, Actavis will grant Mylan a license to market its generic version of Generess® FE under its pending Abbreviated New Drug Application beginning on April 1, 2015. Alternatively, Mylan will be permitted to launch an authorized generic version of Actavis' product beginning on October 1, 2015. Other terms of the settlement were not disclosed. Actavis remains in litigation with Lupin Ltd in connection with Lupin's pending ANDA for a generic version of Generess.
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December 24, 2014
08:30 EDTACTAdamas entitled to $30M milestone payment after Namzaric NDA approved
As reported earlier, Adamas Pharmaceuticals (ADMS) and Actavis (ACT) announced that the FDA has approved the New Drug Application for Namzaric, formerly known as MDX-8704. As a result, Adamas is entitled to a $30M milestone payment pursuant to its license agreement with Forest Laboratories, a subsidiary of Actavis, the company disclosed in a regulatory filing.
08:03 EDTACTActavis and Adamas announce FDA approval of Namzaric
Actavis (ACT) and Adamas Pharmaceuticals (ADMS) announced that the FDA has approved the New Drug Application for Namzaric, a fixed-dose combination of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor. Namzaric was approved for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on memantine hydrochloride and donepezil hydrochloride.
December 22, 2014
09:26 EDTACTActavis names Jonathan Kellerman Global Chief Compliance Officer
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07:41 EDTMYLMylan launches generic version of Vivelle-DOT
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December 19, 2014
16:20 EDTACTActavis confirms receipt of positive CHMP opinion for XYDALBA
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11:26 EDTACTAlmirall says unaware of Actavis approach, hasn't received bid, Reuters reports
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11:23 EDTACTActavis considering bid for Spain based Almirall, Bloomberg reports
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11:02 EDTACTActavis receives positive CHMP recommendation for dalbavancin
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10:59 EDTACTActavis considering bid for Spain based Almirall, Bloomberg reports
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December 18, 2014
10:41 EDTMYLHigh option volume stocks
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December 17, 2014
10:53 EDTACTAckman says 'will take hard look' at Valeant shares after restrictions end
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December 16, 2014
16:53 EDTACTAuxilium updates court findings in Actavis testosterone gel patent suit
Auxilium (AUXL) disclosed in a filing that as previously disclosed, on May 23 , Auxilium Pharmaceuticals, and FCB I LLC, as licensor of Testim, filed a lawsuit in the U.S. District Court for the District of New Jersey against Actavis (ACT) for infringement of FCB’s 10 patents listed in the Orange Book as covering Testim testosterone gel. The lawsuit was filed in response to a notice letter, dated April 12, 2012, sent by Actavis Laboratories, regarding its filing with the U.S. Food and Drug Administration of an Abbreviated New Drug Application for a generic 1% testosterone gel product. This letter also stated that the ANDA contained Paragraph IV certifications with respect to the nine patents listed in the Orange Book on that date as covering Testim. The company’s lawsuit filed against Actavis initially involved those nine patents, as well as a 10th patent covering Testim that was issued on May 15, 2012 and is listed in the Orange Book. By the time that the trial commenced in September 2014, the parties had agreed to remove all but one of those patents from the litigation, with the trial focused solely on claim 3 of U.S. Patent # 7,608,607 . The trial commenced in September 2014 and closing arguments occurred in November 2014. On December 16 , the company learned that Judge Linares held that claim 3 of the ‘607 patent is invalid for obviousness. The Judge also found claim 3 invalid for derivation and improper inventorship, but he declined to rule on whether correction of inventorship would be appropriate because it would be futile in light of his ruling on obviousness. Auxilium believes that Actavis is now free to enter the market with its testosterone gel product once it obtains approval from the FDA. At this time, Auxilium is not aware of Actavis having received tentative approval or final approval from the FDA for its testosterone gel product. Auxilium is analyzing the District Court’s opinion and will explore its available options with regard to this matter.
09:52 EDTACT, MYLFDA ruling on generic Celebrex reversed by appeals court
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08:53 EDTACTActavis accretion targets look more achievable, says Sterne Agee
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07:40 EDTACTActavis reports Saunders to lead combined company as CEO
Actavis (ACT) announced the planned senior management team that will lead the global pharmaceutical company following the successful close of the acquisition of Allergan (AGN), anticipated in the second quarter of 2015. Brent Saunders will continue to lead Actavis as CEO and President and a member of the Board of Directors. Paul Bisaro will remain Executive Chairman of the board of directors. The company noted that it anticipates continuing to define the subsequent management levels within the global organization as rapidly as possible between now and the close of the acquisition. Actavis announced that, following the close of the acquisition, its global brand sales and marketing will be structured into three organizations: International Brands, Branded Pharma and Allergan Medical. "Although we are acting rapidly in announcing these appointments, we are making them following extensive discussions with David Pyott, Chairman and CEO of Allergan, and his executive leadership team. We believe that by announcing the proposed structure of the combined organization our shareholders, customers and employee teams will better appreciate our commitment to create the most dynamic company in Growth Pharma and will share our confidence in seamless execution of this combination beginning on Day 1," Saunders said.
December 15, 2014
15:14 EDTACTActavis to appeal injunction requiring Namenda IR distribution
Actavis confirmed that it is filing an emergency appeal to the U.S. Court of Appeals for the Second Circuit seeking to immediately overturn a lower court ruling requiring the company to continue distribution of NAMENDA immediate-release tablets after Judge Robert Sweet of the U.S. District Court for the Southern District of New York issued a preliminary injunction requiring Actavis to continue distribution of NAMENDA immediate-release tablets on Monday, December 15. Actavis reiterated that the ruling will have no impact on its ability to continue focusing its resources on transitioning patients to the convenient and innovative once-daily NAMENDA XR, and that the company is prepared to manage its business in a way that provides the least disruption in its ability to support the marketplace and minimize any financial impact. Further, the company noted that it will work to manage sales and R&D expenses to ensure that, if the District Court decision stands, it will have minimal to no impact on Actavis' 2015 NAMENDA franchise contribution to earnings and longer term company earnings aspirations.
07:58 EDTACTAllergan downgraded to Hold from Buy at Stifel
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December 11, 2014
19:06 EDTACTActavis confirms court ruling to require continued distribution of Namenda IR
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07:32 EDTMYLMylan launches generic version of Hikma Maple's Robaxin injection
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07:06 EDTMYLMylan launches generic version of Orapred ODT
Mylan announced the U.S. launch of its Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg. This product is the first generic version of Shionogi's Orapred ODT. Mylan received final approval from the FDA for its Abbreviated New Drug Application for Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg, and was awarded 180 days of generic drug marketing exclusivity. This product is indicated as an anti-inflammatory or immunosuppressive agent for certain conditions; and also for the treatment of certain endocrine conditions, and for palliation of certain neoplastic conditions. Prednisolone Sodium Phosphate Orally Disintegrating Tablets had U.S. sales of approximately $19.9M for the 12 months ending September 30.
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