Articles By Estel Grace Masangkay
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Merck’s Keytruda Improves Melanoma PFS In Phase 2 Study
11/20/2014
Merck reported positive results from a pivotal Phase 2 study of anti-PD-1 therapy Keytruda (pembrolizumab) as treatment for ipilimumab-refractory advanced melanoma.
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AstraZeneca Presents Phase 3 Results For Lesinurad Combo In Gout
11/20/2014
AstraZeneca presented top-line results from two pivotal Phase 3 trials assessing lesinurad in combination with xanthine oxidase (XO) inhibitor allopurinol in patients with gout.
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Novartis Posts Phase 3 Results For Secukinumab In AS
11/19/2014
Novartis reported positive results from two pivotal Phase 3 studies of secukinumab AIN457) investigating the drug in ankylosing spondylitis (AS).
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Genzyme’s Lemtrada For MS Approved By The FDA
11/19/2014
Sanofi’s subsidiary Genzyme announced that Lemtrada (alemtuzumab) has been approved by the U.S. Food and Drug Administration (FDA) as a treatment for patients with relapsing forms of multiple sclerosis (MS).
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Janssen’s Invega Sustenna sNDA Approved By FDA
11/18/2014
Johnson & Johnson company Janssen Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted approval to the company’s Supplemental New Drug Application (sNDA) for Invega Sustenna as a monotherapy or adjunct treatment for schizoaffective disorder.
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FDA Clears Roche’s Strep A Infection Test
11/18/2014
Roche announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its cobas Strep A test for the detection of group A streptococcus bacterial (Strep A) DNA.
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GSK Files EU Marketing Authorization Application For Eltrombopag In Anemia
11/17/2014
GlaxoSmithKline announced that it has submitted a marketing authorization application to the European Medicines Agency (EMA) for eltrombopag to include an additional indication for the treatment of severe aplastic anemia (SAA).
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AstraZeneca Begins Pre-Clinical Program For Brilinta Reversal Agent
11/17/2014
British drug maker AstraZeneca announced that it has initiated pre-clinical development of an investigational antibody MEDI2452 as a reversal agent for heart drug Brilinta in patients who need urgent surgery or are experiencing a major bleeding event.
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QIAGEN And Novartis Partner For Companion Diagnostics
11/14/2014
QIAGEN, a Netherlands-based company specializing in assays and technologies, announced that it has signed into a master collaboration agreement with Swiss pharmaceutical firm Novartis to develop companion diagnostics for Novartis’ products.
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MedImmune To Present New Data On Autoimmune Drugs At ACR 2014
11/14/2014
AstraZeneca’s global biologics R&D arm MedImmune announced that it will be presenting new data for five of its drugs being developed for inflammation and autoimmune diseases at the upcoming American College of Rheumatology (ACR) 2014 Annual Meeting in Boston, Massachusetts.