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Stock Market & Financial Investment News

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 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.
October 15, 2014
17:03 EDTNVSNovartis announces CTL019 data demonstrating efficacy in certain ALL patients
Novartis and the University of Pennsylvania's Perelman School of Medicine announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine, or NEJM, evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia, or r/r ALL. The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor, or CAR, therapy CTL019. Largest published cohort to date for CTL019, which served as the basis for recent Breakthrough Therapy designation from the FDA. Sustained remissions of up to two years in r/r ALL patients with six-month event-free survival of 67% and overall survival of 78%.
October 14, 2014
11:23 EDTNVSBIND Therapeutics and The Conference Forum hold a conference
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07:46 EDTACTActavis should be able to mitigate Irish tax downside, says Leerink
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06:03 EDTACTMarket overreacted to new Irish tax rules, says BMO Capital
BMO Capital believes the market may have overreacted yesterday to the report that Ireland is eliminating the "Double Irish" tax loophole. The firm says Allergan (AGN) confirmed that it incorporated potential changes to Irish tax law in its recently raised earnings guidance while Mallinckrodt (MNK) said it does expect the new tax structure to have an immediate impact. BMO views yesterday's pullback in shares of Allergan, Mallinckrodt and Actavis (ACT) as an overreaction.
October 13, 2014
15:12 EDTACTActavis may see modest negative impact from Irish tax change, says BMO Capital
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