BioCentury | Jul 18, 2016
Clinical News

OneCrinone regulatory update

...Juniper said Japan approved OneCrinone progesterone as a luteal phase supplementation in assisted reproductive treatment. Merck...
...Crinone outside Japan, and it is approved in 96 countries. Allergan has U.S. rights to Crinone...
...NASDAQ:JNP), Boston, Mass. Merck KGaA (Xetra:MRK), Darmstadt, Germany Product: OneCrinone ( Crinone ) progesterone ( Prochieve...
BioCentury | Sep 1, 2014
Company News

Columbia Laboratories, XenoGesis deal

...plc (NYSE:ACT, Dublin, Ireland), received a complete response letter from FDA for an NDA for Prochieve...
BioCentury | Sep 23, 2013
Company News

Columbia Laboratories, Molecular Profiles deal

...technical support for its Crinone progesterone to Molecular Profiles and improve responsiveness to its largest Crinone...
...S.A. unit of Merck KGaA (Xetra:MRK, Darmstadt, Germany). Merck Serono has exclusive marketing rights to Crinone...
BioCentury | Apr 15, 2013
Company News

Columbia Laboratories, Merck KGaA sales and marketing update

...granting Merck's Merck Serono S.A. unit exclusive marketing rights to Crinone progesterone outside the U.S. Crinone...
BioCentury | Oct 29, 2012
Clinical News

Crinone regulatory update

...February complete response letter for Prochieve vaginal progesterone gel. The company was seeking approval for Prochieve...
...of the NDA." Watson did not disclose details. Watson markets the product under the name Crinone...
...Columbia Laboratories Inc. (NASDAQ:CBRX), Livingston, N.J. Watson Pharmaceuticals Inc. (NYSE:WPI), Parsippany, N.J. Product: Crinone , Prochieve...
BioCentury | Oct 27, 2012
Company News

FDA denies Watson's formal dispute resolution request

...February complete response letter for Prochieve vaginal progesterone gel. The company was seeking approval for Prochieve...
...of the NDA." Watson did not disclose details. Watson markets the product under the name Crinone...
BioCentury | Apr 2, 2012
Finance

Doubling down

...Watson Pharmaceuticals Inc. (NYSE:WPI) Receives a complete response letter from FDA for an NDA for Prochieve...
BioCentury | Mar 19, 2012
Company News

Columbia Laboratories genitourinary news

...Parsippany, N.J.) said it received a complete response letter from FDA for an NDA for Prochieve...
...birth indication. Watson markets the vaginal progesterone gel delivered via the Bioadhesive Delivery System as Crinone...
BioCentury | Mar 5, 2012
Finance

Highlights of weekly biotech stock moves

...by 10 (42%) to 14 in the wake of an FDA complete response letter for Prochieve...
BioCentury | Mar 5, 2012
Clinical News

Prochieve regulatory update

...Watson said it received a complete response letter from FDA for an NDA for Prochieve vaginal...
...determine next steps. In January, an FDA panel voted 13-4 that the benefit-risk profile of Prochieve...
...Columbia Laboratories Inc. (NASDAQ:CBRX), Livingston, N.J. Watson Pharmaceuticals Inc. (NYSE:WPI), Parsippany, N.J. Product: Prochieve ( Crinone...
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