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News Breaks
June 19, 2014
08:36 EDTACT, NVSDistrict court rules against Actavis' generic version of Novartis' Exelon
Actavis (ACT) confirmed that the U.S. District Court for the District of Delaware has found certain claims of two U.S. patents valid and infringed by Actavis' generic version of Novartis' (NVS) Exelon Patch. Actavis is reviewing the court's decision and will evaluate all available options, including an appeal. Exelon Patch is a prescription medicine used to treat people with mild to moderate dementia associated with Alzheimer's or Parkinson's disease. Actavis' Abbreviated New Drug Application for its generic version of Exelon Patch is currently pending with the FDA.
News For ACT;NVS From The Last 14 Days
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December 16, 2014
09:52 EDTACTFDA 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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08:47 EDTNVSHemispherx Ampligen provides anti-tumor activity
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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.
07:06 EDTNVSBioLineRx and Novartis enter into strategic collaboration agreement
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05:48 EDTNVSNovartis gains FDA approval for Signifor LAR
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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 12, 2014
08:36 EDTNVSNovartis reports BOLERO-1 trial did not meet primary objective
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05:31 EDTNVSNovartis reports Cosentyx 'superior' in head-to-head psoriasis study
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December 11, 2014
19:06 EDTACTActavis confirms court ruling to require continued distribution of Namenda IR
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December 10, 2014
11:40 EDTACTActavis management to meet with Sterne Agee
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09:33 EDTACTActavis launches generic version of Celebrex
Actavis (ACT) announced that it has launched a generic version of Celebrex 50 mg, 100 mg, 200 mg and 400 mg capsules, as part of a settlement agreement with Pfizer (PFE). Celebrex is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. For the 12-month period ending June 30, 2014, Celebrex had U.S. sales of approximately $2.4 billion, according to IMS Health data.
December 9, 2014
09:31 EDTACTZoetis drops after report of Valeant abandoning growth by acquisitions strategy
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06:14 EDTACTAllergan price target raised to $245 from $210 at Citigroup
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December 8, 2014
13:07 EDTNVSNovartis announces data from Jakavi trial
Novartis (NVS) announced data from the largest clinical trial of myelofibrosis patients treated with Jakavi, supporting the safety profile and efficacy benefit as measured in primary and secondary endpoints respectively. In an analysis of 1,144 patients treated with Jakavi to date in this ongoing expanded access study, 69% of patients achieved >50% reduction in spleen size from baseline and patients also experienced a clinically meaningful improvement in myelofibrosis symptom score, important treatment goals for patients with myelofibrosis. Findings from the study were presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, California. Novartis research and development efforts, in collaboration with Incyte Corporation (INCY), include early-phase and post-marketing studies in myelofibrosis and other myeloproliferative neoplasms. More than 50 abstracts on ruxolitinib are being presented at ASH, including three oral presentations exploring combinations of ruxolitinib with various investigational compounds, evaluating the possibility of simultaneously targeting multiple cancer pathways that may be involved in the pathogenesis of myelofibrosis. The JUMP study is a Phase IIIb, expanded-access trial for countries with no access to Jakavi outside of a clinical trial. The open-label, multicenter study analyzed 1,144 enrolled myelofibrosis patients who received daily starting doses of either 5 mg, 15 mg or 20 mg of Jakavi twice daily based on platelet counts at baseline. The primary endpoint is assessment of safety and tolerability of Jakavi. Overall, the safety and efficacy profile of Jakavi was consistent with previous studies.
13:05 EDTNVSNovartis reports six-year results from Phase III ENESTnd study
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12:25 EDTACTAntibiotic makers rise after Merck agrees to buy Cubist
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11:30 EDTNVS, ACTLeerink generics pharmaceutical analyst holds analyst/industry conference call
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05:42 EDTNVSSandoz Phase III data shows filgrastim has similar safety, efficacy as NEUPOGEN
Sandoz, a Novartis (NVS) company, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen's (AMGN) NEUPOGEN in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity. The PIONEER study was a Phase III study designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to mean duration of severe neutropenia following Cycle 1 chemotherapy. PIONEER was a randomized, double-blind, four-group, multi-center non-inferiority trial conducted at 27 centers. The trial randomized 218 breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy.
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