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Tag: investigational
02.06.15 -- OPKO Submits Investigational New Drug Application For Factor VIIa-CTP To Treat Hemophilia
2015-02-05 02:31:23| drugdiscoveryonline News Articles
02/06/15 Drug Discovery Online Newsletter
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OPKO Submits Investigational New Drug Application To Initiate A Phase 2a Trial For Its Long-Acting Coagulation Factor VIIa-CTP To Treat Hemophilia
2015-02-04 06:38:34| drugdiscoveryonline Home Page
OPKO Health, Inc. announced the submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) to conduct a Phase 2a study of OPKO's long-acting version of coagulation Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX
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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
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Investigational drug increases PFS in patients with advanced breast cancer
2014-12-17 14:34:20| Biotech - Topix.net
In a groundbreaking study that offers new hope for women with advanced breast cancer, researchers from UCLA's Jonsson Comprehensive Cancer Center have published final clinical trial results that showed the amount of time patients were on treatment without their cancer worsening was effectively doubled in women with advanced breast cancer who took the experimental drug palbociclib. An investigational drug discovered and being developed by Pfizer Inc., palbociclib targets a key family of proteins responsible for cell growth by preventing them from dividing.
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Merck Submits New Drug Application to the Japanese Pharmaceuticals and Medical Devices Agency for Omarigliptin, an Investigational Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes
2014-11-24 14:00:00| Merck.com - Product News
Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, 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 for omarigliptin, its investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes, to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Language: English Contact: MerckMedia:Pam Eisele267-305-3558orKim Hamilton908-740-1863 / 908-391-0131orInvestors:Justin Holko908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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