je.st
news
Tag: chmp
Biogen and Sobi Receive Positive Opinion from CHMP for ELOCTAa ...
2015-09-26 06:58:18| Appliances - Topix.net
CAMBRIDGE, Mass. & STOCKHOLM -- -- Biogen and Swedish Orphan Biovitrum AB received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for the marketing authorization of ELOCTA .
Tags: receive
positive
opinion
biogen
Celgene's VIDAZA (Azacitidine for Injection) Receives Positive CHMP...
2015-09-25 15:59:38| Biotech - Topix.net
Expanded indication brings medicine to elderly AML patients who are not eligible for haematopoietic stem cell transplantation and who have >30% myeloblasts in their bone marrow BOUDRY, Switzerland-- -- Celgene International SA rl, a wholly owned subsidiary of Celgene Corporation today announced that that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for an expanded indication of VIDAZAA for the treatment of adult patients aged 65 years or older with acute myeloid leukaemia who are not eligible for haematopoietic stem cell transplantation .
Tags: positive
receives
injection
chmp
Merck Receives Positive CHMP Opinion for Investigational Antibiotic ZERBAXA (Ceftolozane and Tazobactam)
2015-07-27 14:30:00| Merck.com - Product 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of the investigational antibiotic ZERBAXA (ceftolozane and tazobactam) for the treatment of the following infections in adults: complicated intra-abdominal infections, acute pyelonephritis, and complicated urinary tract infections. Language: English Contact: MerckMedia:Pam Eisele, 267-305-3558orRobert Consalvo, 908-236-1127orInvestors:Joseph Romanelli, 908-740-1986orJustin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: positive
opinion
receives
antibiotic
Merck Receives Positive CHMP Opinion for KEYTRUDA (pembrolizumab) for the Treatment of Advanced Melanoma
2015-05-22 13:12:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Opinion for KEYTRUDA Based on Efficacy and Safety Data in More than 1,500 Patients with Advanced Melanoma as Both First-Line Therapy and in those Previously Treated KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the treatment of advanced (unresectable or metastatic) melanoma, as both first-line therapy and in previously treated patients. Language: English Contact: MerckMedia:Pam Eisele, 267-305-3558Claire Mulhearn, 908-236-1118orInvestors:Joseph Romanelli, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: advanced
positive
opinion
treatment
Merck Announces CHMP Issues Positive Opinion for Investigational Antibiotic SIVEXTRO (tedizolid phosphate)
2015-01-26 14:30:00| 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of the investigational antibiotic SIVEXTRO (tedizolid phosphate) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Merck acquired SIVEXTRO as a part of its purchase, through a subsidiary, of Cubist Pharmaceuticals, Inc. Language: English Contact: Media:Pam Eisele, 267-305-3558Jennifer Baird, 781-860-1282orInvestor:Joseph Romanelli, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: issues
positive
opinion
announces