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April 16, 2013
11:43 EDTNVS, BAYRY, ACTAppeals court reverses ruling in Actavis patent suit against Bayer
Watson Pharmaceuticals, now known as Actavis (ACT), along with Novartis' (NVS) Sandoz, unit and Lupin Pharmaceuticals, appealed the final judgments of the United States District Court for the District of Nevada in favor of Bayer Healthcare Pharmaceuticals and Bayer Schering Pharma (BAYRY). The Defendants challenged the district court’s entry of summary judgment that asserted claims 13 and 15 of Bayer’s U.S. "’564 patent” are not invalid for obviousness. The appeals court ruled in favor of the generic drug makers and reversed the lower court ruling. Reference Link
News For ACT;BAYRY;NVS From The Last 14 Days
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December 16, 2014
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.
07:56 EDTBAYRYUBS to hold a conference
Agriculture Investor Day is being held in Chicago on December 10.
December 9, 2014
12:22 EDTBAYRYPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
10:23 EDTBAYRYOn The Fly: Analyst Downgrade Summary
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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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05:38 EDTBAYRYBayer downgraded to Neutral from Buy at BofA/Merrill
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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.
December 5, 2014
16:49 EDTACTAdvisory Committee recommends approval Of Actavis' ceftazidime-avibactam
Actavis announced that the Anti-Infective Drugs Advisory Committee convened by the U.S. Food and Drug Administration has voted to recommend approval of Actavis' New Drug Application for ceftazidime-avibactam, an investigational antibiotic being developed to treat hospitalized patients when limited or no treatment options are available for complicated intra-abdominal infections and complicated urinary tract infections caused by Gram-negative pathogens. The committee found the scientific and clinical evidence submitted by Cerexa, a wholly owned subsidiary of Actavis, adequately demonstrated the safety and efficacy of ceftazidime-avibactam in the treatment of the proposed cIAI and cUTI indications. The committee voted not to recommend approval of the combination for hospital-acquired bacterial pneumonia /ventilator-associated bacterial pneumonia and bacteremia.The Advisory Committee recommendation is not binding on the FDA, which makes the final decision regarding approval. Actavis expects FDA action on its NDA for ceftazidime-avibactam during the first quarter of 2015.
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