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Stock Market & Financial Investment News

News For NVS;ARRY;AZN From The Last 14 Days
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September 3, 2015
17:57 EDTAZNAstraZeneca confirms FDA approval of Brilinta tablets
AstraZeneca confirmed that the FDA has approved Brilinta tablets at a new 60mg dose to be used in patients with a history of heart attack beyond the first year. With this expanded indication, Brilinta is now approved to reduce the rate of cardiovascular death, myocardial infarction, or MI also known as heart attack, and stroke in patients with acute coronary syndrome, or ACS, or a history of MI. Brilinta is an oral antiplatelet treatment that works by inhibiting platelet activation and was first approved by the FDA in July 2011 on the basis of data from the PLATO study. For at least the first 12 months following ACS, it is superior to clopidogrel and is the first and only FDA approved oral antiplatelet to demonstrate superior reductions in CV death vs clopidogrel. Brilinta also reduces the rate of stent thrombosis in patients who have been stented for the treatment of ACS. In the management of ACS, the recommended maintenance dose of Brilinta is 90mg twice daily during the first year after an ACS event. After one year, patients with a history of heart attack can now be treated with 60mg twice daily. Brilinta should be used with a daily maintenance dose of aspirin of 75-100mg.
17:27 EDTAZNAstraZeneca: FDA approves expanded indication for BRILINTA
AstraZeneca announced that the U.S. FDA has approved BRILINTA tablets at a new 60mg dose to be used in patients with a history of heart attack beyond the first year. With this expanded indication, BRILINTA is now approved to reduce the rate of cardiovascular death, myocardial infarction and stroke in patients with acute coronary syndrome or a history of MI. The new BRILINTA 60mg tablet is expected to be available in pharmacies by the end of September 2015. Reference Link
September 2, 2015
16:20 EDTNVSHealth Canada approves new indications for PrOmnitrope
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12:22 EDTNVSAmgen denied injunction to block Novartis copy of Neupogen, Reuters reports
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12:15 EDTNVSAmgen denied injunction to block Novartis copy of Neupogen, Bloomberg reports
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10:00 EDTAZNOn The Fly: Analyst Upgrade Summary
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06:41 EDTAZNAstraZeneca upgraded to Buy from Hold at HSBC
HSBC upgraded AstraZeneca to Buy based on recent shares weakness and a large amount of Oncology and ImmunoOncology news flow in the coming months.
05:35 EDTNVSNovartis receives EU approval for Revolade
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September 1, 2015
16:33 EDTNVSAmgen, Novartis enter agreement for Alzheimer's, migraine research
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08:33 EDTAZNNektar receives $40M milestone payment from first commercial sale of Moventig
Nektar (NKTR) announced that it has received a $40M cash payment under a license agreement with AstraZeneca (AZN). The payment was triggered by the first commercial sale of MOVENTIG (naloxegol) in Germany. MOVENTIG is the first once-daily, oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication approved in the European Union for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxatives. MOVENTIG is marketed in the U.S. by AstraZeneca as MOVANTIK and is the first once-daily oral PAMORA medication indicated for the treatment of OIC in adult patients with chronic, non-cancer pain. MOVENTIG/MOVANTIK is part of the exclusive worldwide license agreement announced on September 21, 2009 between AstraZeneca and Nektar Therapeutics. Under the terms of the agreement, in addition to the $40 million milestone payment announced today, Nektar received a $100 million milestone payment upon first commercial sale of MOVANTIK in the U.S. in March of 2015. Nektar is also entitled to royalties on worldwide net product sales and up to $375 million in sales milestones. The royalty rate in the U.S. starts at 20% and escalates. The royalty rate in Europe and the rest of the world starts at 18% and escalates. Under the agreement, AstraZeneca is responsible for all sales and marketing activities for MOVANTIK worldwide.
05:33 EDTAZNValeant, AstraZeneca to partner on brodalumab
Valeant Pharmaceuticals (VRX) announced that its affiliate has entered into a collaboration agreement with AstraZeneca (AZN) under which Valeant was granted an exclusive license to develop and commercialize brodalumab. Brodalumab is an IL-17 receptor monoclonal antibody in development for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. Under the agreement, Valeant will hold the exclusive rights to develop and commercialize brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin under a prior arrangement with Amgen Inc., the originator of brodalumab. Valeant will assume all development costs associated with the regulatory approval for brodalumab. Regulatory submission in U.S. and EU for brodalumab in moderate-to-severe psoriasis is planned for Q4. Under the terms of the agreement, Valeant will make an up-front payment to AstraZeneca of $100M, as well as additional pre-launch milestones of up to $170M and further sales-related milestone payments of up to $175M following launch. After approval, AstraZeneca and Valeant will share profits.
August 28, 2015
05:32 EDTNVSNovartis renews pledge with WHO to end leprosy
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August 27, 2015
07:51 EDTAZNRoche catching up fast to Bristol-Myers in immuno-oncology, says Jefferies
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August 25, 2015
15:02 EDTNVSMylan says USPTO institutes IPR of two Copaxone patents
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August 24, 2015
13:15 EDTNVSFDA expands use of Novartis' Promacta to include children ages 1 and older
Ligand Pharmaceuticals (LGND) announced that the FDA has approved an expanded use for Promacta, a Novartis (NVS) product, to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was acquired by Novartis in March from GlaxoSmithKline (GSK). Promacta was discovered as a result of research collaboration between GSK and Ligand Pharmaceuticals and was developed by GSK. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 years of age and older and in 2008 for use in adult patients with the same condition. The label expansion of Promacta was based on data from two double-blind, placebo-controlled trials, including the largest Phase 3 clinical trial in this patient population. Treatment with Promacta significantly increased and sustained platelet counts among pediatric patients with chronic ITP with an insufficient response to prior chronic ITP therapies, and some patients taking concomitant ITP medications were able to reduce or discontinue their use of these medications, primarily corticosteroids. Promacta should be used only in those whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
12:11 EDTNVSNovartis announces FDA approves expanded use for Promacta
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05:13 EDTAZNAstraZeneca to collaborate with Peregrine on cancer immunotherapy clinical trial
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August 23, 2015
12:35 EDTAZNBiotech firms could see 'billions' in sales from new cancer drugs, Barron's says
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August 21, 2015
17:29 EDTARRYArray BioPharma files automatic mixed securities shelf
05:25 EDTNVSNovartis acquires all remaining rights to Ofatumumab from GSK
Novartis (NVS) announced that it has entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline (GSK). Ofatumumab, a fully human monoclonal antibody which targets CD20, is being developed for relapsing remitting multiple sclerosis, or RRMS, and other autoimmune indications. Novartis previously acquired the rights to Ofatumumab for oncology indications and it is marketed under the brand name Arzerra. Novartis will be responsible for the worldwide development, regulatory and commercialization activities for Ofatumumab. Under the terms of the agreement, Novartis will make an initial upfront payment of $300M to GSK for the acquisition of the compound and a further payment of $200M payable following the start of a phase III study in MS by Novartis. Upon completion of pre-determined milestones, contingent payments of up to $534M may be made. Novartis will also pay royalties of up to 12% to GSK on any future net sales of Ofatumumab in autoimmune conditions.
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