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News Breaks
February 22, 2013
07:25 EDTACT, NVSEMA gives positive recommendation for Actavis' generic imatinib
The Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Imatinib Actavis, 50 mg and 100 mg hard capsule and 100 mg 400 mg Film-coated tablet intended for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia for whom bone marrow transplantation is not considered as the first line of treatment, pediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis, or adult patients with Ph+ CML in blast crisis. The applicant for this medicinal product is Actavis Group (ACT). Imatinib Actavis is a generic of Novartis' (NVS) Glivec.
News For ACT;NVS From The Last 14 Days
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October 27, 2014
06:28 EDTNVSVirbac acquires veterinary assets from Eli Lilly in U.S.
Virbac announces that it has entered into an agreement with Eli Lilly (LLY) to acquire "major" U.S. veterinary products currently marketed by Novartis (NVS) Animal Health. Eli Lilly has agreed to divest these U.S. assets in connection with the U.S. Federal Trade Commission’s review of Eli Lilly’s pending acquisition of Novartis Animal Health worldwide. Under the terms of this agreement, Virbac would acquire a combination of titles and rights for the U.S. on trademarks, marketing authorizations, patents, know-how, customer lists and other assets, related to two parasiticides for dogs including Sentinel Flavor Tabs and Sentinel Spectrum, currently marketed in the U.S. by Novartis Animal Health. In the U.S., Sentinel Flavor tabs and Sentinel Spectrum are expected to reach total revenues of approximately $90M-$100M in 2014. Adding these brands and commercial franchise to the current Virbac portfolio of products offered to veterinary clinics and pet owners in the U.S. will strengthen Virbac’s presence and penetration in the U.S. companion animal veterinary market and leverage its growth potential. The completion of this transaction is subject to approval by the Federal Trade Commission, which Virbac expects may be received in the near future. It is also conditioned on the closing of the acquisition of Novartis Animal Health by Eli Lilly and should occur shortly thereafter.
October 23, 2014
18:18 EDTACTGlenview Capital acquires stake in Actavis, Bloomberg reports
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11:57 EDTNVSNovartis management to meet with Jefferies
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08:10 EDTACTActavis confirms appeals court upholds Lo Loestrin Fe patent
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05:21 EDTNVSNovartis AIN457 meets primary endpoint in two Phase III studies in AS
Novartis announced that AIN457 met primary and key secondary endpoints in two pivotal Phase III studies, MEASURE 1 and MEASURE 2, in patients with ankylosing spondylitis, or AS. Key endpoints included improvements in signs and symptoms of the disease versus placebo and associated improvements in physical function and quality of life. Secukinumab is an investigational medicine that works by stopping the action of interleukin- 17A, a protein that is central to the development of inflammatory diseases, including AS. MEASURE 1 and MEASURE 2 enrolled a combined total of approximately 600 patients. Detailed results of the studies will be presented at an upcoming medical congress. Joint regulatory applications for secukinumab in AS and PsA are planned for 2015. This follows the secukinumab global regulatory applications for moderate- to-severe plaque psoriasis which were filed in October 2013 with regulatory decisions anticipated in late 2014 or early 2015.
October 22, 2014
08:38 EDTACTActavis signs option to acquire Rhythm Health
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07:44 EDTNVSGlaxoSmithKline backs FY14 view for core EPS 'broadly similar' to FY13
GlaxoSmithKline (GSK) continues to expect full year 2014 core EPS to be broadly similar to 2013 at CER and on ex-divestment basis. Glaxo says its proposed 3-part transaction with Novartis (NVS) is on track for completion in 1H15.
October 21, 2014
07:15 EDTNVSFDA to hold workshop on breast cancer drug development
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06:44 EDTACTActavis among bidders for Omega Pharma, Bloomberg reports
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October 20, 2014
18:51 EDTACTOn The Fly: After Hours Movers
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15:09 EDTNVSNovartis reports FDA advisory committee recommends approval of secukinumab
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the FDA voted unanimously to support the approval of AIN457, or secukinumab, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. A Biologics License Application for secukinumab is currently under FDA review with an anticipated action date in early 2015.
07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
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06:28 EDTACTAllergan price target raised to $210 from $190 at Citigroup
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October 17, 2014
14:50 EDTNVSBARDA asks labs to ramp up Zmapp production, Reuters says
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09:47 EDTACTValeant will not raise Allergan bid ahead of record date, CNBC reports
Valeant (VRX) will not raise its hostile takeover bid for Allergan (AGN) ahead of the record date for the vote, CNBC's David Faber reports. Allergan (AGN) is not currently in takeover talks with Actavis (ACT), Faber added.
09:45 EDTACTAllergan not in deal talks with Actavis, CNBC reports
October 16, 2014
17:27 EDTACTNoven files patent infringement suit against Actavis
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15:10 EDTACTAmerican College of Gastroenterology to hold annual meeting
ACG Annual Scientific Meeting 2014 to be held in Philadlephia, PA on October 17-22.
08:08 EDTACTActavis confirms generic Quillivant XR patent challenge
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08:02 EDTACTIronwood announces initiation of Phase II linaclotide trial
Ironwood Pharmaceuticals (IRWD) announced the initiation of a Phase II clinical trial evaluating linaclotide for the treatment of adults suffering from opioid-induced constipation. Data are expected in the second half of 2015. The clinical trial is being conducted jointly by Ironwood and Actavis plc (ACT), Ironwood’s co-development and co-promotion partner for linaclotide in the United States. Linaclotide is a guanylate cyclase-C agonist approved by the FDA for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Linaclotide is not currently approved for the treatment of OIC. The randomized, double-blind, placebo-controlled, multi-site Phase II clinical trial is expected to enroll approximately 240 adult patients with chronic, non-cancer pain who have been receiving a stable dose of an opioid analgesic and suffer from constipation, defined as fewer than three spontaneous bowel movements per week. Patients will be randomized to receive 145 mcg of linaclotide, 290 mcg of linaclotide, or placebo for eight weeks. The primary endpoint of the trial is an increase in SBM frequency. Additionally, a number of secondary endpoints and exploratory analyses intended to inform future development plans are included in the study design.
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