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FDA Accepts Supplemental Biologics License Application, Assigns Priority Review and Grants Breakthrough Therapy Designation to Mercks KEYTRUDA (pembrolizumab) for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer
2016-09-07 12:45:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Merck Has Also Submitted a Marketing Authorization Application to the European Medicines Agency for KEYTRUDA in the Same Patient Population Submissions Based on Data from KEYNOTE-024 Trial Showing Superior Progression-Free and Overall Survival Compared to Chemotherapy in Patients Whose Tumors Express High Levels of PD-L1 KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, with a PDUFA, or target action, date of Dec. 24, 2016. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orCourtney Ronaldo, 908-236-1108orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: advanced
review
application
license
The gene therapy revolution is coming. Will the US get left behind?
2016-08-08 19:00:04| Extremetech
US lawmakers have saddled American biotech with another legal restriction, and scientists are only partially engaging with this looming medical and economic problem.
Pigs Demonstrate Potential of Gene Therapy for Metabolic Liver Diseases
2016-07-28 02:00:00| ThePigSite - Industry News
US - As part of research to find a new approach to correct metabolic disorders in humans without a whole organ transplant, a study has tested gene therapy in pigs suffering from hereditary tyrosinemia type 1 (HT1), a metabolic disorder caused by an enzyme deficiency.
Tags: potential
therapy
demonstrate
gene
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
Hemophilia cures are proving gene therapy really is all its cracked up to be
2016-06-15 18:30:07| Extremetech
A number of incoming cures for hemophilia are notable precisely because they're so mundane -- this is the sort of breakthrough we can expect to see again, and again, and again in the near future.
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