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News Breaks
February 9, 2013
14:51 EDTARRY, NVS, AZNArray expects to make progress on generating data on hematology programs
In a press release Array BioPharma said : During 2013, Array (ARRY) expects to make substantial progress in generating data to inform registration study decisions for our wholly-owned hematology programs, ARRY-520 and ARRY-614. Array-invented MEK162 will be tested in a Phase 3 trial in NRAS melanoma which is scheduled to start in April 2013, as well as BRAF mutant melanoma later in 2013 (with Novartis (NVS)). Also, AstraZeneca (AZN) recently announced a potential start of a Phase 3 trial with Array-invented selumetinib in non-small cell lung cancer during the second half of 2013.
News For ARRY;NVS;AZN From The Last 14 Days
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October 17, 2014
14:50 EDTNVSBARDA asks labs to ramp up Zmapp production, Reuters says
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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%.
10:48 EDTAZNShire tanks with AbbVie calling board meeting over merger
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October 14, 2014
11:23 EDTAZN, NVSBIND Therapeutics and The Conference Forum hold a conference
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October 13, 2014
10:08 EDTAZNOn The Fly: Analyst Upgrade Summary
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09:21 EDTAZNOn The Fly: Pre-market Movers
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07:53 EDTAZNAstraZeneca upgraded to Buy from Hold at Jefferies
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05:27 EDTAZNAstraZeneca upgraded to Buy from Hold at Jefferies
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October 10, 2014
08:53 EDTARRYArray drug has little evidence of being effective, says Summer Street
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05:13 EDTNVSNovartis reports new analyses of AIN457 Phase III data show consistent efficacy
Novartis announced that new analyses of AIN457 Phase III studies showed that treatment with secukinumab 300 mg resulted in higher rates of clear to almost clear skin at Week 12 versus placebo, regardless of patients' psoriasis disease severity. Secukinumab's new mode of action stops interleukin-17A, which plays a central role in the development of psoriasis. In the analyses, the majority of patients across two disease severity subgroups, including those with severe psoriasis, experienced complete clear to almost clear skin measured as 100 or 90% reduction of respective baseline PASI, or Psoriasis Area and Severity Index. Skin clearance was sustained through one year of treatment. This is important as historically, psoriasis patients' disease severity at the start of treatment has been shown to negatively impact their response to other therapies. Disease severity subgroups were PASI less than or equal to 20 and PASI greater than 20. PASI measures redness, scaling and thickness of psoriatic plaques and the impact in regions of the body. These findings reconfirm the significantly better responses seen in the published FIXTURE study, where secukinumab showed superiority to Enbrel, a standard of care anti-TNF medication.
October 9, 2014
09:20 EDTARRYSummer Street chief scientific officer holds an analyst/industry conference call
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08:10 EDTAZNAstraZeneca reports Phase IIb study of benralizumab met primary endpoint
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October 8, 2014
11:05 EDTNVSLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analyst discusses congestive heart failure and the prospects for LCZ696 in HF-PEF on an Analyst/Industry conference call to be held on October 9 at 3 pm.
07:19 EDTNVSCBI to hold a conference
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06:11 EDTNVSNovartis says expects three executive committee members to leave
Novartis (NVS) confirmed that following completion of the transactions with GlaxoSmithKline (GSK) and Eli Lilly and Company (LLY) in the coming months, that the three business leaders of the Novartis divisions at the center of the transaction will leave the Executive Committee of Novartis. The expected changes to the ECN are subject to the closing of the transactions announced on April 22 - Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with Eli Lilly for its Animal Health Business to close in the first quarter of 2015. George Gunn, currently Division Head, Novartis Animal Health, will reach his contractual retirement age in July 2015 and will retire from Novartis. Upon closing of the Animal Health transaction with Lilly he will leave the ECN. Brian McNamara, currently Division Head, Novartis OTC, will transition to GSK as Head of Americas and Europe for the consumer health businesses, reporting to the President of GSK Consumer Healthcare, effective at closing of the transaction. Andrin Oswald, currently Division Head, Novartis Vaccines, will be leaving Novartis to pursue other opportunities following closing of the transaction with GSK.
October 7, 2014
08:39 EDTNVSImmunoGen says Novartis exercises rights to take licenses under agreement
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07:48 EDTAZNSalix reinstated with a Buy at Jefferies
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October 6, 2014
08:04 EDTNVSBristol-Myers announces Opdivo clinical trial with Novartis therapies
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07:32 EDTAZNAstraZeneca confirms AHA, ACC updated guideline
AstraZeneca confirmed that the American Heart Association and American College of Cardiology have updated the guideline for the management of patients with non–ST-elevation acute coronary syndromes. The guideline supports differentiation among currently available P2Y12 inhibitors, including ticagrelor, clopidogrel, and prasugrel, for these patients. BRILINTA is now preferred over clopidogrel for the management of NSTE-ACS patients who undergo an early invasive or ischemia-guided strategy or those who receive a coronary stent. This is the first time the AHA and ACC have recommended one P2Y12 over another in the treatment of acute coronary syndrome. The approved Prescribing Information for BRILINTA includes information about the approved uses for BRILINTA. BRILINTA has two Boxed WARNINGS, one for bleeding risk and the other for aspirin dose and reduced BRILINTA effectiveness. The Boxed WARNING on BLEEDING RISK states, like other antiplatelet agents, BRILINTA can cause significant, sometimes fatal, bleeding.
05:14 EDTNVSNovartis announce clinical collaboration with Bristol-Myers
Novartis (NVS) announced that it has entered into a clinical collaboration with Bristol-Myers Squibb (BMY) to evaluate the safety, tolerability and preliminary efficacy of three molecularly targeted compounds in combination with Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, Opdivo, in Phase I/II trials of patients with non-small cell lung cancer, or NSCLC. Both studies will be conducted by Novartis. One trial will evaluate the combination of Opdivo with Zykadia, an FDA-approved treatment for patients with anaplastic lymphoma kinase-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. A second study will investigate Opdivo with INC280, a potent and highly selective inhibitor of c-MET receptor tyrosine kinase, and separately with EGF816, a potent, third-generation EGFR tyrosine kinase inhibitor that is active against T790 mutations. INC280 and EGF816 are currently being investigated in various Phase I/II NSCLC trials. Additional details of the collaboration were not disclosed.
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