Pivotal Phase 3 Trial for Pediatric Praziquantel Completes with Positive Results
Astellas Pharma Inc.
New pediatric formulation of Praziquantel, which Astellas Pharma Inc. (“Astellas”) provided its formulation technology and has been developed under the initiative of Merck together with its consortium partners, has now been completed its pivotal Phase 3 trial. The favorable results of this clinical trial allow the program to progress towards regulatory file submission to the European Medicines Agency (EMA).
Cambridge, Mass.– December 17, 2021 – Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the Committee for Medicinal P...
22/12/2021PRESS RELEASE Survey
Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for the Treatment of HER2 Positive Advanced Gastric Cancer
Tokyo, Munich– (November 3, 2021) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the European Medicines Agency (EM...
09/11/2021PRESS RELEASE Corporate Announcements
The European Medicines Agency (EMA) has accepted for review under an accelerated assessment procedure the Marketing Authorization Application (MAA) fo...
18/12/2021PRESS RELEASE Research Findings
EMA Adopts a Positive CHMP Opinion for Pfizer’s and OPKO’s Somatrogon, a Long-Acting Treatment for Pediatric Growth Hormone Deficiency
NEW YORK, NY [December 17, 2021] - Pfizer Inc. (NYSE: PFE) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the Europ...
22/12/2021PRESS RELEASE Corporate Announcements