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Tag: ema
EMA concerned that EPAs revisiting Phase 2 GHG rules could lead to misaligned regulatory requirements
2017-08-22 11:56:26| Green Car Congress
Tags: lead
rules
requirements
phase
Merck Receives Breakthrough Therapy Designation from FDA and PRIME Status from EMA for Investigational Ebola Zaire Vaccine (V920)
2016-07-25 14:00:00| Merck.com - Corporate 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 two regulatory milestones for the companys investigational vaccine for Ebola Zaire, V920 (rVSVG-ZEBOV-GP, live attenuated): the U.S. Food and Drug Administration (FDA) has granted the vaccine candidate Breakthrough Therapy Designation, and the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) status. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Skip Irvine, 215-652-6059orInvestors:Teri Loxam, 908-740-1986Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: status
prime
therapy
receives
Certara's Synchrogenix Division Provides Unique Technology Solution, Enabling Biopharma Companies To Comply With EMA Policy 70
2016-03-30 06:49:06| drugdiscoveryonline Home Page
Certara, the global biosimulation technology-enabled drug development company, recently announced that its regulatory and medical consultancy, Synchrogenix, has introduced an artificial intelligence (AI) -enabled solution to meet the data transparency requirements of the clinical and drug development market
Tags: policy
technology
unique
companies
European Medicines Agency (EMA) Approves Use of Ingelvac CircoFLEXÂ During Pig Pregnancy, Lactation
2015-09-10 02:00:00| ThePigSite - Industry News
EU - The European Medicines Agency (EMA) has granted the use of Boehringer Ingelheim’s Ingelvac CircoFLEX® during pregnancy and lactation in sows. The vaccine is registered worldwide for the protection of pigs against Porcine Circovirus Type 2 (PCV2) related diseases. Ingelvac CircoFLEX® reduces mortality, clinical signs and lesions associated with PCV2.
Tags: agency
european
pregnancy
pig
MM-398 Receiving The Priority Review Designation By US FDA For New Drug Application And The Acceptance Of Market Authorization Application By EMA In Post-Gemcitabine Metastatic Pancreatic Cancer
2015-07-01 08:52:42| drugdiscoveryonline Home Page
PharmaEngine, Inc. (TWO: 4162) announced that (1) its license partner, Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK), has received the notification from the US Food and Drug Administration (FDA) for the acceptance and the grant of the priority review designation for their New Drug Application (NDA); and (2) its sublicense partner, Baxalta Incorporated, a wholly owned subsidiary of Baxter International Inc. (NYSE: BAX) has received the acceptance of Market Authorization Application (MAA) from the European Medicines Agency (EMA), of MM-398 (irinotecan liposome injection, also known as "nal-IRI,") in the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy
Tags: review
market
application
drug