BioCentury | Aug 18, 2014
Clinical News

Corifollitropin alfa regulatory update

...Merck disclosed in its 2Q14 financial results that FDA issued a complete response letter for corifollitropin alfa...
...approved in >50 markets outside the U.S., including the EU, where it is marketed as Elonva...
...NYSE:MRK), Whitehouse Station, N.J. Product: Corifollitropin alfa ( Elonva ) ( SCH 900962 , MK-8962 ) (formerly Org 36286...
BioCentury | Jul 30, 2014
Financial News

Merck CEO not interested in inversion deals

...Merck also disclosed in its earnings that FDA issued a complete response letter for corifollitropin alfa...
BioCentury | Sep 16, 2013
Clinical News

Corifollitropin alfa regulatory update

...FDA accepted for review an NDA from Merck for corifollitropin alfa for controlled ovarian stimulation to treat...
...approved in >50 markets outside the U.S., including the EU, where it is marketed as Elonva...
...NYSE:MRK), Whitehouse Station, N.J. Product: Corifollitropin alfa ( Elonva ) ( SCH 900962 , MK-8962 ) (formerly Org 36286...
BioCentury | Feb 1, 2010
Clinical News

Elonva corifollitropin alfa regulatory update

...The EC approved an MAA from Merck for Elonva corifollitropin alfa injection for controlled ovarian stimulation in...
...multiple follicles to treat infertility in women participating in an assisted reproductive technology (ART) program. Elonva...
...stimulating hormone (FSH). Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Elonva corifollitropin alfa (formerly Org 36286...
BioCentury | Dec 7, 2009
Clinical News

Elonva corifollitropin alfa regulatory update

...EMEA's CHMP issued a positive opinion on an MAA from Merck for Elonva corifollitropin alfa for use...
...stimulation in combination with a gonadotropin-releasing hormone (GnRH) antagonist to treat infertility. The application for Elonva...
...the centralized procedure. Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Elonva corifollitropin alfa (formerly Org 36286...
BioCentury | Jul 6, 2009
Clinical News

Corifollitropin alfa: Phase II data

...stimulation in the open-label, uncontrolled Phase II REALIZE trial showed that 100 and 150 ug corifollitropin alfa...
...started cycle was 15.4 +/-6.7 for 100 ug corifollitropin alfa and 17.8 +/-5.1 for 150 ug corifollitropin alfa...
...Human Reproduction and Embryology meeting in Amsterdam. Schering-Plough Corp. (NYSE:SGP), Kenilworth, N.J. Product: Corifollitropin alfa (formerly Org 36286...
BioCentury | Jul 6, 2009
Clinical News

Corifollitropin alfa: Phase III data

...Data from the double-blind, international Phase III ENSURE trial showed that 100 ug corifollitropin alfa significantly increased...
...arms. The incidence of moderate and severe ovarian hyperstimulation syndrome (OHSS) was 3.3% for the corifollitropin alfa...
...Human Reproduction and Embryology meeting in Amsterdam. Schering-Plough Corp. (NYSE:SGP), Kenilworth, N.J. Product: Corifollitropin alfa (formerly Org 36286...
BioCentury | Mar 16, 2009
Strategy

Merck/Schering-Plough pipeline

...review in the U.S. and Europe for rheumatoid arthritis (RA) and other autoimmune conditions, and corifollitropin alfa...
BioCentury | Mar 16, 2009
Strategy

Merck's challenges

...come with baggage. Besides golimumab, Schering-Plough has three compounds from the Organon deal in registration: corifollitropin alfa...
...as corifollitropin alfa is essentially a me-too product and the other two have had regulatory problems. Corifollitropin alfa...
BioCentury | Jan 5, 2009
Clinical News

Corifollitropin alfa regulatory update

...EMEA accepted for review an MAA from Schering-Plough for subcutaneous Corifollitropin alfa to treat infertility. The application...
...women participating in an assisted reproductive program. Schering-Plough Corp. (NYSE:SGP), Kenilworth, N.J. Product: Corifollitropin alfa (formerly Org 36286...
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