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June 11, 2014
17:19 EDTAMGN, AZNAmgen says Phase 2 study of brodalumab met primary endpoint
Amgen (AMGN) and AstraZeneca (AZN) announced that results from a Phase 2 study evaluating brodalumab in 168 patients with psoriatic arthritis were published in The New England Journal of Medicine. These data will also be presented at the 2014 European League Against Rheumatism Annual Congress in Paris on June 14.. Brodalumab is the only investigational treatment in development that binds to the interleukin-17 receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes. The study showed that treatment with brodalumab significantly improved signs and clinical symptoms associated with the disease, including tender and swollen joints, at 12 weeks as measured by a 20% improvement in the American College of Rheumatology response criteria. The study also showed that many patients continued to improve, and that the improvements were sustained, through the first 52 weeks of the study reported in NEJM. The study achieved its primary endpoint with both doses of brodalumab exhibiting superiority to placebo in ACR20 responses at week 12. These responses continued to improve through 24 weeks and were sustained through the first 52 weeks of the study.1 ACR response criteria are a measure of improvement in tender and swollen joints, as well as patient and physician global assessments of disease activity, pain, disability and inflammatory markers. A 20% improvement from baseline in ACR response rates is known as ACR20, a 50% improvement from baseline is known as ACR50 and a 70% improvement from baseline is known as ACR70.
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July 30, 2014
09:38 EDTAMGNActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL AMZN TWTR NFLX GILD C MA FB RFMD AMGN GNW TSLA
09:04 EDTAMGNOn The Fly: Pre-market Movers
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07:04 EDTAMGNAmgen price target raised to $138 from $125 at RBC Capital
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06:16 EDTAMGNOptions expected to be active: TWTR BWLD AXP DWA PNRA AMGN X FB
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06:10 EDTAZNAstraZeneca enters respiratory disease transaction with Almirall
AstraZeneca announced that it has entered an agreement to transfer to the company the rights to Almirall’s respiratory franchise for an initial consideration of $875M on completion, and up to $1.22B in development, launch, and sales-related milestones. AstraZeneca has also agreed to make various sales-related payments. Upon completion of the transaction, AstraZeneca will own the rights for the development and commercialization of Almirall’s existing proprietary respiratory business, including rights to revenues from Almirall’s existing partnerships, as well as its pipeline of investigational novel therapies. The franchise includes Eklira, LAS40464, LAS100977 or abediterol, and multiple pre-clinical programs. Under the agreement, Almirall Sofotec, an Almirall subsidiary focused on the development of innovative proprietary devices, will also transfer to AstraZeneca. Almirall’s pipeline of respiratory assets and its device capabilities further strengthen AstraZeneca’s respiratory portfolio, which includes Symbicort and Pulmicort, as well as the company’s investigational medicines in development. The addition of aclidinium and the combination of aclidinium with formoterol, both in proprietary Genuair device, will allow AstraZeneca to offer patients a choice between dry powder inhaler and metered dose inhaler devices across a range of molecules and combinations. AstraZeneca and Almirall anticipate that, subject to local consultation and legislation, a significant number of employees dedicated to the respiratory business, including Almirall Sofotec employees, will transfer to AstraZeneca. The transaction is subject to certain competition law clearances as well as other customary terms and conditions. The companies anticipate the transaction will complete by the end of 2014.Reference Link
06:00 EDTAMGNAmgen price target raised to $150 from $143 at Piper Jaffray
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July 29, 2014
18:35 EDTAMGNOn The Fly: After Hours Movers
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16:22 EDTAMGNAmgen says total product sales increased 8% in Q2
Total product sales increased 8% for the second quarter of 2014 versus the second quarter of 2013. The increase was mainly driven by ENBREL, Kyprolis, Prolia and XGEVA. Product sales in the second quarter of 2013 included a positive adjustment of $185M to previous estimates for managed Medicaid rebates based on claims experience.
16:21 EDTAMGNAmgen to reduce global workforce by 12%-15%
The company announced a restructuring plan today to invest in continuing innovation and the launch of its new pipeline molecules, while improving its cost structure. Initial efforts include streamlining the organization, reducing layers of management, increasing managerial spans of responsibility and beginning implementation of a revised geographic site plan. As a first step, the company will reduce staff by 2,400-2,900, beginning later this year and continuing through 2015, predominantly in the U.S. This represents approximately 12% to 15% of Amgen’s global workforce. The company will also close its facilities in the states of Washington and Colorado
16:19 EDTAMGNAmgen raises FY14 EPS view to $8.20-$8.40 from $7.90-$8.20, consensus $8.09
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16:16 EDTAMGNAmgen reports Q2 EPS $2.37, consensus $2.07
Reports Q2 revenue $5.18B, consensus $4.9B.
15:53 EDTAMGNNotable companies reporting after market close
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13:49 EDTAMGNEarnings Preview: Amgen counting on newer drugs to boost sales
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11:11 EDTAMGNAmgen technical comments before results
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July 28, 2014
05:36 EDTAZNQIAGEN, AstraZeneca announce collaboration
QIAGEN (QGEN) announced a collaboration agreement with AstraZeneca (AZN) for the co-development and commercialization of a liquid biopsy-based companion diagnostic to be paired with IRESSA, AstraZeneca's targeted therapy for non-small cell lung cancer, or NSCLC. The project builds on a master framework agreement signed by both companies in 2013 and aims to develop and market a novel QIAGEN companion diagnostic that analyzes plasma samples to assess EGFR mutation status in NSCLC patients. The assay will be designed to guide the treatment of NSCLC patients with Astra Zeneca's oral monotherapy anti-cancer treatment when tumor tissue is not available. QIAGEN already offers the therascreen EGFR RGQ PCR Kit as a tissue-based companion diagnostic for lung cancer patients, which was approved in the U.S. by the FDA in July 2013 and in China in May 2014. The companies will collaborate to create a new companion diagnostic for IRESSA based on liquid biopsy samples from NSCLC patients, rather than requiring invasive surgical collection of tissue samples. Data from several studies, including the IFUM Study presented at the "World Lung 2013" conference, provided evidence of the ability to assess the EGFR status of advanced lung cancer patients using blood / plasma samples. This breakthrough provides hope for patients for whom surgical biopsy is not an option by enabling them to have their EGFR mutation status assessed using a less invasive method.
July 25, 2014
09:19 EDTAMGNAmgen weekly volatility elevated into Q2 and outlook
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07:36 EDTAMGNEMA adopts positive opinion on new indication for Xgeva
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05:35 EDTAMGNBayer, Onyx reports NEXAVAR Phase 3 trial did not meet primary endpoint
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July 22, 2014
05:25 EDTAZNAdams Express, MedImmune announce clinical trial partnership
Advaxis (ADXS) has entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca (AZN). The Phase I/II immunotherapy study will evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis' lead cancer immunotherapy vaccine, ADXS-HPV, as a treatment for patients with advanced, recurrent or refractory human papillomavirus, or HPV,-associated cervical cancer and HPV-associated head and neck cancer. Both MEDI4736 and ADXS-HPV are cancer immunotherapies, a new class of treatments that use the body's own immune system to help fight cancer. Under the terms of the agreement, MedImmune and Advaxis will evaluate the combination as a treatment for HPV-associated cervical cancer and squamous cell carcinoma of the head and neck. The Phase I part of the trial is expected to establish a recommended dose regimen of MEDI4736 with ADXS-HPV, and the Phase II portion will assess the safety and efficacy of the combination. The study will be funded and conducted by Advaxis. Results from the study will be used to determine whether further clinical development of this combination is warranted. Under the terms of the deal, MedImmune has a non-exclusive relationship with respect to HPV-driven tumour types. MedImmune has first right of negotiation for future development of combinations involving MEDI4736 and ADXS-HPV.
July 17, 2014
16:10 EDTAMGNAmgen announces positive Phase 3 results for AMG 416
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