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Breakthrough therapy
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#	Item
41	Breakthrough Therapy Program U.S. Food and Drug Administration (FDA) Presentation before the European Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2015-02-13 09:30:33 Clinical research Health Pharmaceutical industry Epidemiology FDA Fast Track Development Program Clinical trial New Drug Application Imaging biomarker Pharmaceutical sciences Pharmacology Food and Drug Administration
42	CY 2015 CDER Breakthrough Therapy Calendar Year Approvals Data as of January 09, 2015 Application Number Add to Reading List Source URL: www.fda.gov
43	Media Inquiries: Jessica Rowlands 202-‐729-‐4089 [removed] Spark Therapeutics Receives FDA Breakthrough Therapy Designation f Add to Reading List Source URL: www.sparktx.com Language: English - Date: 2014-11-25 08:45:10 Emerging technologies Gene delivery Medical genetics Medical research Molecular biology Gene therapy Adeno associated virus and gene therapy of the human retina Biology RPE65 Medicine
44	November 20, 2014 Regeneron and Sanofi Announce that Dupilumab Has Received FDA Breakthrough Therapy Designation in Atopic Dermatitis TARRYTOWN, N.Y. and PARIS, Nov. 20, 2014 /PRNewswire/ -- Regeneron Pharmaceuticals, I Add to Reading List Source URL: files.shareholder.com Language: English Medicine Immunosuppressants Macrolides Atopic dermatitis Regeneron Eczema Pharmacology Dermatitis Atopy Health Type 1 hypersensitivity Immune system
45	CDER Breakthrough Therapy Requests Received in Fiscal Year 2015 Cohort: October 1, [removed]November 28, 2014 Total Requests Received Add to Reading List Source URL: www.fda.gov
46	CDER Breakthrough Therapy Designations Withdrawn after Granting or Rescinded in Fiscal Year 2012 Cohort: July 9, 2012*- September 30, 2012 Data as of September 30, 2012 Withdrawn After Granting Add to Reading List Source URL: www.fda.gov
47	CDER Breakthrough Therapy Designations Withdrawn after Granting or Rescinded in Fiscal Year 2015 Cohort: October 1, [removed]November 28, 2014 Withdrawn After Granting Add to Reading List Source URL: www.fda.gov
48	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use QUARTETTE® safely and effectively. See full prescribing information for QUARTETTE. Quartette® (levonorgestrel/ethi Add to Reading List Source URL: www.herquartette.com Language: English - Date: 2014-08-22 12:19:51 Reproduction Oral contraceptive formulations Combined oral contraceptive pill Levonorgestrel Ethinylestradiol Hormone replacement therapy Estradiol Lamotrigine Breakthrough bleeding Hormonal contraception Endocrine system Medicine
49	“Fortis Cardiac Surgeons Perform Breakthrough Heart Surgery” ~Successfully implant India’s first ‘HEARTMATE II’ LVAD for heart failure~ For more than 1.5million patients in India who annually suffer from heart Add to Reading List Source URL: www.fortishealthcare.com Language: English - Date: 2014-10-20 18:49:25 Cardiology Prosthetics Ventricular assist device Destination therapy Thoratec LVAD Heart failure Cardiac surgery O. H. Frazier Medicine Interventional cardiology Implants
50	SYNAGEVA’S SEBELIPASE ALFA RECEIVES BREAKTHROUGH THERAPY DESIGNATION FOR EARLY ONSET LAL DEFICIENCY FROM THE U.S. FOOD AND DRUG ADMINISTRATION LEXINGTON, Mass., May 20, [removed]Synageva BioPharma Corp. (Synageva) (NASD Add to Reading List Source URL: www.synageva.com Language: English - Date: 2013-05-20 07:13:10 Wolman disease Lysosomal Acid Lipase Deficiency Cholesteryl ester storage disease Lysosomal storage disease Mucopolysaccharidosis Sanfilippo syndrome Wolman Acid lipase disease Lysosomal lipase Health Rare diseases Lipid storage disorders