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FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Mercks Anti-PD-1 Therapy, in Advanced Non-Small Cell Lung Cancer, and Grants Priority Review
2015-06-01 22:34:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. KEYNOTE-001 Data Served as the Basis for U.S. FDA Filing and Breakthrough Therapy Designation in Advanced NSCLC Across Histologies KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Mercks anti-PD-1 therapy, KEYTRUDA (pembrolizumab), for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present. Language: English Contact: MerckMedia:Pamela Eisele, 267-664-0282Claire Mulhearn, 908-200-1889orInvestors:Joseph Romanelli, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Retail Therapy: What happened to Urban Outfitters?
2015-05-31 03:49:49| Apparel - Topix.net
The Urban Outfitters at Fashion Fair closed quietly weeks ago, leaving behind a big blue shell in the outdoor portion of the mall. But the Fresno closure appears to be a reflection of troubles facing the retailer nationwide.
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Bluebird Bio: Transforming The Gene Therapy Landscape In Rare Diseases
2015-05-30 04:35:43| Trucking - Topix.net
Initial SCD data is due in June and significant upside remains if LentiGlobin proves to make a difference in patient lives. The company is in an excellent fundamental position and is well positioned to progress towards late-stage and regulatory submissions.
New Findings Show Durable Anti-Tumor Activity with KEYTRUDA (pembrolizumab), Mercks Anti-PD-1 Therapy, in Patients with Advanced Head and Neck Cancer, Regardless of PD-L1 Expression Status
2015-05-29 20:06:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Results from KEYNOTE-012, the First and Largest Study to Date of an Anti-PD-1 Therapy in Head and Neck Cancer, to be Presented at 2015 ASCO Annual Meeting KEYTRUDA Monotherapy Achieved Overall Response Rate of 25 Percent in Heavily Pre-treated Patients Merck is Advancing a Broad Head and Neck Clinical Program for KEYTRUDA with Five Clinical Trials, Across Multiple Lines of Therapy and in Combination with Other Agents KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced new investigational data evaluating KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, as a monotherapy from the KEYNOTE-012 Phase 1b study in 132 pre-treated patients with recurrent or metastatic head and neck cancer, regardless of PD-L1 expression status. Language: English Contact: MerckMedia:Pamela Eisele, 267-664-0282Claire Mulhearn, 908-200-1889orInvestors:Joseph Romanelli, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Merck Submits U.S. New Drug Application for Grazoprevir/Elbasvir, an Investigational Once-Daily, Single Tablet Combination Therapy, for Treatment of Chronic Hepatitis C Genotypes 1, 4, and 6 Infection
2015-05-28 22:30:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for grazoprevir/elbasvir (100mg/50mg), an investigational once-daily, single tablet combination therapy for the treatment of adult patients with chronic hepatitis C genotypes (GT) 1, 4 or 6 infection. Within 60 days of submission, the FDA will determine whether it will accept for review Merck's application as filed. Language: English Contact: MerckMedia:Doris Li, 908-246-5701orSarra Herzog, 908-740-1871orInvestors:Joe Romanelli, 908-740-1986orJustin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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