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News Breaks
July 28, 2014
05:36 EDTQGEN, AZNQIAGEN, 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.
News For QGEN;AZN From The Last 14 Days
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January 21, 2015
12:30 EDTAZNGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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10:16 EDTAZNLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
January 14, 2015
07:37 EDTAZNJPMorgan to hold a conference
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07:03 EDTAZNAstraZeneca says Pegasus-TIMI 54 study met primary efficacy endpoint
AstraZeneca announced that the PEGASUS-TIMI 54 study, a large scale outcomes trial involving over 21,000 patients, successfully met its primary efficacy endpoint. The study assessed BRILINTA tablets at either 60mg twice daily or 90mg twice daily plus low-dose aspirin for the secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study start. The primary efficacy endpoint was a composite of cardiovascular death, myocardial infarction or stroke. Preliminary analysis did not reveal any unexpected safety issues. Full evaluation of the data is ongoing. The PEGASUS-TIMI 54 study investigated two different doses of ticagrelor on a background of low dose aspirin versus placebo plus low dose aspirin, in patients aged 50 and older with a history of heart attack and one additional CV risk factor. The study was designed to better understand the management of patients more than 12 months after their heart attack, who remain at high risk for major thrombotic events. Complete results from the PEGASUS-TIMI 54 study will be submitted to a scientific meeting in 2015 and pending further analysis, AstraZeneca plans to file this data with regulatory health authorities. The PEGASUS-TIMI 54 study is part of AstraZeneca’s PARTHENON program. The PLATO study, involving over 18,000 ACS patients, was the first study in the program and is the basis on which ticagrelor has been approved in over 100 countries and included in 12 major ACS treatment guidelines globally. Further ongoing PARTHENON studies are investigating ticagrelor for the prevention of cardiovascular events in patients with peripheral arterial disease, ischaemic stroke or transient ischaemic attack, and in patients with diabetes and coronary atherosclerosis. BRILINTA is not approved for secondary prevention of atherothrombotic events in patients with a history of heart attack beyond one year or for the prevention of cardiovascular events in patients with PAD, stroke, diabetes or atherosclerosis.
07:03 EDTAZNAstraZeneca says Pegasus-TIMI 54 study met primary efficacy endpoint
January 12, 2015
09:31 EDTQGENTokai Pharmaceuticals announces collaboration with QIAGEN
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08:37 EDTAZNShire deal suggests most biotech companies in play, says JMP Securities
After Shire (SHPG) agreed to buy NPS Pharmaceuticals (NPSP), JMP Securities says the deal indicates that most biotech companies are in play, particularly those with worldwide rights to their products for well-defined patient populations. The firm expects investors to speculate all week about potential new targets in the space. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
05:36 EDTAZN, QGENQIAGEN announces regulatory registration of lung cancer companion diagnostic
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